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Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer

Primary Purpose

Lung Cancer, Non-Small Cell

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

HYCAMTIN, oral capsules

Radiation

About this trial

This is an interventional treatment trial for Lung Cancer, Non-Small Cell focused on measuring Brain metastases from Non-Small Cell Lung Cancer, Brain metastases brain tumor lung cancer oral chemotherapy HYCAMTIN topotecan NSCLC WBRT whole brain radiation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

At least one measurable cancerous lesion in the brain from primary non-small cell lung cancer (NSCLC)
Must have received previous chemotherapy
Must be 18 years of age of greater
Must be Easter Cooperative Oncology Group (ECOG) Performance Status 0, 1, 2
At least 2 weeks must have elapsed since any surgery
At least 4 weeks must have elapsed since any radiation to a non-CNS site
Must have adequate bone marrow, renal, and live capacities
Women must be of non-childbearing potential or practice adequate birth control
Males must practice adequate methods of birth control
Must sign written informed consent

Exclusion criteria:

Previous whole brain radiation therapy
Prior treatment with topotecan
Investigational agent within 30 days or 5 half-live
Concomitant therapy with inhibitors of breast cancer resistance protein (BCRP) or P-glycoprotein such as erlotinib or gefitinib
Primary or secondary immunodeficiencies
Gastrointestinal conditions that affect GI absorption or motility
Uncontrolled emesis
Brain metastasis at time of initial diagnosis of NSCLC
History of other malignancy except in situ carcinoma of cervix; nonmelanomatous skin cancer, low grade prostate cancer
Pregnant or intending to become pregnant or intending to father a baby
Any severe concurrent medical condition that could affect compliance.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

topotecan plus radiation

Whole brain radiation

Arm Description

topotecan 1.1 mg/m2 followed by whole brain radiation 3 Gy/day for 10 days, followed by optional continuation therapy with topotecan 2.3 mg/m2 for 5 days Q21 days as monotherapy.

Whole brain radiation 3 Gy/day for 10 days

Outcomes

Primary Outcome Measures

Overall Survival

Overall survival is defined as the time from randomization until the date of death due to any cause. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored.

Secondary Outcome Measures

Six-month Survival

Six-month survival is defined as the percentage of participants alive at 6 months following randomization. The date of last contact was used for those participants who had not died or were lost to follow-up. These participants were classified as having been censored.

Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic)

The number of participants achieving either a CR or PR, per World Health Organization (WHO) Criteria, in the CNS was assessed. CR is defined as the complete disappearance of all known measurable (Must be accurately measured in >=1 dimension) and nonmeasurable disease, without clinical, laboratory, or radiological evidence of recurrence for at least 4 weeks. CR may have been defined in participants with measurable and/or non-measurable disease at Screening. PR is defined as at least a 50% decrease in the sum of the products of the greatest length and perpendicular width of all measurable disease with no clear increase in nonmeasurable disease in participants without measurable disease. In both cases, there must have been no appearance of new disease, and no clinical, laboratory, or radiological evidence of disease progression for at least 4 weeks. Assessment of response was performed by the investigator and was based on unconfirmed responses.

Time to Response (TTR) (CNS-radiologic)

TTR is defined as the time from Randomization until the first documented evidence of CR or PR in the CNS. CR is defined as the complete disappearance of all known measurable (Must be accurately measured in >=1 dimension) and nonmeasurable disease, without clinical, laboratory, or radiological evidence of recurrence for at least 4 weeks. CR may have been defined in participants with measurable and/or non-measurable disease at Screening. PR is defined as at least a 50% decrease in the sum of the products of the greatest length and perpendicular width of all measurable disease with no clear increase in nonmeasurable disease in participants without measurable disease. In both cases, there must have been no appearance of new disease, and no clinical, laboratory, or radiological evidence of disease progression for at least 4 weeks. Assessment of response was performed by the investigator and was based on unconfirmed responses.

Time to Progression (TTP) (CNS-radiologic)

TTP is defined as the time from Randomization until the first documented sign of disease progression in the CNS. Progressive disease (PD) is defined as an increase >=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase >=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. TTP was analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before a TTP event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.

Time to Progression (TTP) (All Sites of Disease-radiologic)

TTP is defined as the time from Randomization until the first documented sign of disease progression in all sites of disease. Progressive disease (PD) is defined as an increase >=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase >=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. TTP was analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before a TTP event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.

Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3

Neurological signs and symptoms data were derived from a participant-reported diary. The participants were asked to assess the following signs and symptoms on a scale of none, mild, moderate, or severe at Months 1 and 3: headache, problems with balance/coordination (PB/C), leg weakness, arm weakness, loss of feeling/numbness (LofF/N), speech difficulty (SD), confusion, loss of memory (LofM), drowsiness, nausea, vomiting, dizziness, visual problems (VP), seizures, leg/ankle swelling (L/AS), heart burn, difficulty sleeping (DS), tiredness, and appetite/weight gain (A/WG).

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3

The investigator assessed participants for the neurological sign and symptom of level of consciousness and assigned each participant to one of the following categories: normal; somnolence or sedation not interfering with function (not intefering); somnolence or sedation interfering with function, but not activities of daily living (ADLs) (interfering); obtundation or stupor, difficult to arouse, inteferring with ADLs (obtundation or stupor); coma.

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3

The investigator (per Common Terminology Criteria for Adverse Events [CTCAE], version 3.0) assessed participants for headache and assigned each participant to one of the following categories: absent, Grade (G) 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3

The investigator (per CTCAE, version 3.0) assessed participants for dizziness/lightheadedness and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3

The investigator (per CTCAE, version 3.0) assessed participants for vertigo and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3

The investigator (per CTCAE, version 3.0) assessed participants for nausea/vomiting and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3

The investigator (per CTCAE, version 3.0) assessed participants for visual problem and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3

The investigator (per CTCAE, version 3.0) assessed participants for seizure and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3

The investigator (per CTCAE, version 3.0) assessed participants for other neurological symptoms and assigned each participant to one of the following categories: absent, G 1, G 2, G 3, G 4, and G 5. Grade refers to the severity of the AE. The CTCAE displays G 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: G 1: mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; G 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; G 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self care ADL; G 4: life-threatening consequences, urgent intervention indicated; G 5: death related to AE.

Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3

The investigator assessed participants' status of cranial nerves II-XII and assigned each participant to one of the following categories: normal; present, not interfering with ADLs; present, interfering with ADLs; life threatening, disabling.

Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3

The investigator assessed participants' status of language (dysphasia or aphasia) and assigned each participant to one of the following categories: absent; awareness of receptive or expressive aphasia, not impairing ability to communicate (not impaired); receptive or expressive dysphasia, impairing ability to communicate (impaired); inability to communicate (unable).

Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3

The investigator assessed participants' status of strength (right upper extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.

Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3

The investigator assessed participants' status of strength (left upper extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.

Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3

The investigator assessed participants' status of strength (right lower extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.

Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3

The investigator assessed participants' status of strength (left lower extremity) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic with weakness on physical examination; Grade 2, symptomatic and interfering with function, but not interfering with ADLs; Grade 3, symptomatic and interfering with ADLs; Grade 4: bedridden or disabling.

Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3

The investigator assessed participants' status of sensation and assigned each participant to one of the following categories: normal; loss of deep tendon reflexes or paresthesia, but not interfering with function (not interfering with function); objective sensory loss or paresthesia interfering with function, but not interfering with ADLs (interfering with function); sensory loss or paresthesia interfering with ADLs (intefering with ADLs); permanent sensory loss that interferes with function (permanent sensory loss).

Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3

The investigator assessed participants' status of ataxia (right upper extremity: finger to nose testing) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.

Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3

The investigator assessed participants' status of ataxia (left upper extremity: finger to nose testing) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.

Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3

The investigator assessed participants' status of ataxia (gait) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.

Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3

The investigator assessed participants' status of ataxia (balance) and assigned each participant to one of the following categories: normal; Grade 1, asymptomatic but abnormal on physical examination, and not interfering with function; Grade 2, mild symptoms interfering with function, but not interfering with ADLs; Grade 3, moderate symptoms interfering with ADLs; Grade 4, bedridden or disabling.

Number of Participants With Any Adverse Event (AE; Both Serious and Non-serious) or Serious Adverse Event (SAE)

An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect. For a list of all SAEs and AEs, see the SAE/AE module of this results summary.

Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range

The worst-case change from Baseline in chemistry parameters was measured as decrease to low (DTL), change to normal or no change (CTN/NC), or increase to high (ITH). The worst-case change value could have been measured at any point during the on-therapy period. Participants are counted twice if the participant "Decreased to Low" and "Increased to High" during the on-therapy period.

Lesion Assessment and Measurement

Lesions were assessed per WHO criteria. For lesion assessment data, see the outcome measure entitled "Number of participants with a complete response (CR) or a partial response (PR) (central nervous system [CNS]-radiologic)."

Brain Symptoms

Brain symptoms were assessed as the number of participants with neurological signs and symptoms. For brain symptom data, see the outcome measures entitled "Number of participants with the indicated investigator assessment for the neurological sign and symptom of X at Baseline, Month 1, and Month 3."

Number of Participants Who Died or Progressed

Disease-related events were measured as the number of participants who died or progressed. Progressive disease (PD) is defined as an increase >=25% in any measurable lesion or, in participants with non-measurable disease only, an estimation of an increase >=25%. In both cases, determination of progression included the appearance of any new lesions, or signification worsening of conditions presumed to be related to malignancy. Participants with clinical or laboratory evidence of possible disease progression were to be evaluated radiologically. Data were analyzed with censoring for extended loss to follow-up to account for two or more missed assessments before an event. The date of the last adequate CNS assessment before extended loss to follow-up was used for censored participants.

Full Information

NCT ID

NCT00390806

First Posted

October 19, 2006

Last Updated

December 5, 2013

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00390806

Brief Title

Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer

Official Title

A Randomized, Phase III, Open-Label Study of Oral Topotecan Plus Whole-Brain Radiation Therapy (WBRT) Compared With WBRT Alone in Patients With Brain Metastases From Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The current prognosis for patients with metastatic brain cancer from NSCLC is very poor. The current standard treatment for this disease is radiation therapy to the brain. The goal of the current study is to test whether the combination of orally administered HYCAMTIN capsules and whole brain radiation therapy will prolong the survival time of patients with this potentially serious condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Non-Small Cell

Keywords

Brain metastases from Non-Small Cell Lung Cancer, Brain metastases brain tumor lung cancer oral chemotherapy HYCAMTIN topotecan NSCLC WBRT whole brain radiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

472 (Actual)

8. Arms, Groups, and Interventions

Arm Title

topotecan plus radiation

Arm Type

Experimental

Arm Description

topotecan 1.1 mg/m2 followed by whole brain radiation 3 Gy/day for 10 days, followed by optional continuation therapy with topotecan 2.3 mg/m2 for 5 days Q21 days as monotherapy.

Arm Title

Whole brain radiation

Arm Type

Active Comparator

Arm Description

Whole brain radiation 3 Gy/day for 10 days

Intervention Type

Drug

Intervention Name(s)

HYCAMTIN, oral capsules

Other Intervention Name(s)

HYCAMTIN, oral capsules

Intervention Description

topotecan oral capsules 1.1 mg/m2

Intervention Type

Radiation

Intervention Name(s)

Radiation

Intervention Description

Whole brain radiation

Primary Outcome Measure Information:

Title

Overall Survival

Description

Time Frame

From the time of Randomization until the date of death due to any cause (up to 195 weeks)

Secondary Outcome Measure Information:

Title

Six-month Survival

Description

Time Frame

Month 6

Title

Number of Participants With a Complete Response (CR) or a Partial Response (PR) (Central Nervous System [CNS]-Radiologic)

Description

Time Frame

From the time of Randomization until the time of CR or PR (up to 75 weeks)

Title

Time to Response (TTR) (CNS-radiologic)

Description

Time Frame

From the time of Randomization until the first documented evidence of CR or PR (up to 75 weeks)

Title

Time to Progression (TTP) (CNS-radiologic)

Description

Time Frame

From the time of Randomization until the first documented sign of disease progression (up to 75 weeks)

Title

Time to Progression (TTP) (All Sites of Disease-radiologic)

Description

Time Frame

From the time of Randomization until the first documented sign of disease progression (up to 75 weeks)

Title

Number of Participants Who Ranked Each Individual Indicated Neurological Sign and Symptom as None, Mild, Moderate, or Severe at Months 1 and 3

Description

Time Frame

Months 1 and 3

Title

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Level of Consciousness at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Headache at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Dizziness/Lightheadedness at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Vertigo at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Nausea/Vomiting at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Visual Problem at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Seizure at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment for the Neurological Sign and Symptom of Other Neurological Symptoms at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment of Cranial Nerves II-XII at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment of Language (Dysphasia or Aphasia) at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment of Strength (Right Upper Extremity) at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment of Strength (Left Upper Extremity) at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment of Strength (Right Lower Extremity) at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment of Strength (Left Lower Extremity) at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment of Sensation at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment of Ataxia (Right Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment of Ataxia (Left Upper Extremity: Finger to Nose Testing) at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment of Ataxia (Gait) at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With the Indicated Investigator Assessment of Ataxia (Balance) at Baseline, Month 1, and Month 3

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants With Any Adverse Event (AE; Both Serious and Non-serious) or Serious Adverse Event (SAE)

Description

Time Frame

From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)

Title

Number of Participants With the Indicated Worst-case Change From Baseline in the Indicated Chemistry Parameters With Respect to the Normal Range

Description

Time Frame

From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)

Title

Lesion Assessment and Measurement

Description

Time Frame

From the time of Randomization until the time of CR or PR (up to 75 weeks)

Title

Brain Symptoms

Description

Time Frame

Baseline, Month 1, and Month 3

Title

Number of Participants Who Died or Progressed

Description

Time Frame

From Randomization until the last clinic visit associated with the study, up until 35 days after the start of the last course of treatment (up to 75 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: At least one measurable cancerous lesion in the brain from primary non-small cell lung cancer (NSCLC) Must have received previous chemotherapy Must be 18 years of age of greater Must be Easter Cooperative Oncology Group (ECOG) Performance Status 0, 1, 2 At least 2 weeks must have elapsed since any surgery At least 4 weeks must have elapsed since any radiation to a non-CNS site Must have adequate bone marrow, renal, and live capacities Women must be of non-childbearing potential or practice adequate birth control Males must practice adequate methods of birth control Must sign written informed consent Exclusion criteria: Previous whole brain radiation therapy Prior treatment with topotecan Investigational agent within 30 days or 5 half-live Concomitant therapy with inhibitors of breast cancer resistance protein (BCRP) or P-glycoprotein such as erlotinib or gefitinib Primary or secondary immunodeficiencies Gastrointestinal conditions that affect GI absorption or motility Uncontrolled emesis Brain metastasis at time of initial diagnosis of NSCLC History of other malignancy except in situ carcinoma of cervix; nonmelanomatous skin cancer, low grade prostate cancer Pregnant or intending to become pregnant or intending to father a baby Any severe concurrent medical condition that could affect compliance.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

GSK Investigational Site

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85304

Country

United States

Facility Name

GSK Investigational Site

City

Hot Springs

State/Province

Arkansas

ZIP/Postal Code

71913

Country

United States

Facility Name

GSK Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

GSK Investigational Site

City

Duarte

State/Province

California

ZIP/Postal Code

91010-3000

Country

United States

Facility Name

GSK Investigational Site

City

Pleasant Hill

State/Province

California

ZIP/Postal Code

94523

Country

United States

Facility Name

GSK Investigational Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80012

Country

United States

Facility Name

GSK Investigational Site

City

Lakeland

State/Province

Florida

ZIP/Postal Code

33805

Country

United States

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

GSK Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

GSK Investigational Site

City

Elk Grove Village

State/Province

Illinois

ZIP/Postal Code

60007

Country

United States

Facility Name

GSK Investigational Site

City

Galesburg

State/Province

Illinois

ZIP/Postal Code

61401

Country

United States

Facility Name

GSK Investigational Site

City

Park Ridge

State/Province

Illinois

ZIP/Postal Code

60068

Country

United States

Facility Name

GSK Investigational Site

City

Rockford

State/Province

Illinois

ZIP/Postal Code

61108

Country

United States

Facility Name

GSK Investigational Site

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60077

Country

United States

Facility Name

GSK Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46227

Country

United States

Facility Name

GSK Investigational Site

City

Westwood

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

Facility Name

GSK Investigational Site

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42003

Country

United States

Facility Name

GSK Investigational Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

GSK Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

GSK Investigational Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

GSK Investigational Site

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65201

Country

United States

Facility Name

GSK Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64154

Country

United States

Facility Name

GSK Investigational Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

Country

United States

Facility Name

GSK Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

GSK Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89135

Country

United States

Facility Name

GSK Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87109

Country

United States

Facility Name

GSK Investigational Site

City

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

GSK Investigational Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

GSK Investigational Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215-1199

Country

United States

Facility Name

GSK Investigational Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

GSK Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43235

Country

United States

Facility Name

GSK Investigational Site

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401-8122

Country

United States

Facility Name

GSK Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29403

Country

United States

Facility Name

GSK Investigational Site

City

Bedford

State/Province

Texas

ZIP/Postal Code

76022

Country

United States

Facility Name

GSK Investigational Site

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78412

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75320-2510

Country

United States

Facility Name

GSK Investigational Site

City

Duncanville

State/Province

Texas

ZIP/Postal Code

75137

Country

United States

Facility Name

GSK Investigational Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

GSK Investigational Site

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79415

Country

United States

Facility Name

GSK Investigational Site

City

Sherman

State/Province

Texas

ZIP/Postal Code

75090

Country

United States

Facility Name

GSK Investigational Site

City

Sugarland

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

GSK Investigational Site

City

Everett

State/Province

Washington

ZIP/Postal Code

98201

Country

United States

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

Washington

ZIP/Postal Code

98684

Country

United States

Facility Name

GSK Investigational Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

GSK Investigational Site

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1C 8X3

Country

Canada

Facility Name

GSK Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Facility Name

GSK Investigational Site

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 5P9

Country

Canada

Facility Name

GSK Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

GSK Investigational Site

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2H1

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 4M1

Country

Canada

Facility Name

GSK Investigational Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

GSK Investigational Site

City

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1529

Country

Hungary

Facility Name

GSK Investigational Site

City

Csorna

ZIP/Postal Code

9300

Country

Hungary

Facility Name

GSK Investigational Site

City

Gyula

ZIP/Postal Code

5703

Country

Hungary

Facility Name

GSK Investigational Site

City

Győr

ZIP/Postal Code

9024

Country

Hungary

Facility Name

GSK Investigational Site

City

Miskolc

ZIP/Postal Code

3529

Country

Hungary

Facility Name

GSK Investigational Site

City

Mátraháza

ZIP/Postal Code

3233

Country

Hungary

Facility Name

GSK Investigational Site

City

Nyíregyháza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

GSK Investigational Site

City

Pécs

ZIP/Postal Code

7623

Country

Hungary

Facility Name

GSK Investigational Site

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

GSK Investigational Site

City

Székesfehérvár

ZIP/Postal Code

8000

Country

Hungary

Facility Name

GSK Investigational Site

City

Törökbálint

ZIP/Postal Code

2045

Country

Hungary

Facility Name

GSK Investigational Site

City

Zalaegerszeg-Pozva

ZIP/Postal Code

8900

Country

Hungary

Facility Name

GSK Investigational Site

City

Bialystok

ZIP/Postal Code

15-540

Country

Poland

Facility Name

GSK Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-769

Country

Poland

Facility Name

GSK Investigational Site

City

Gdansk

ZIP/Postal Code

80-211

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

31-115

Country

Poland

Facility Name

GSK Investigational Site

City

Olsztyn

ZIP/Postal Code

10-226

Country

Poland

Facility Name

GSK Investigational Site

City

Olsztyn

ZIP/Postal Code

10-357

Country

Poland

Facility Name

GSK Investigational Site

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

GSK Investigational Site

City

Kazan

ZIP/Postal Code

420111

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

105229

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

115 478

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

128128

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

129 128

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Obninsk

ZIP/Postal Code

249036

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Orenburg

ZIP/Postal Code

460021

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St-Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Voronezh

ZIP/Postal Code

394062

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Banska Bystrica

ZIP/Postal Code

975 17

Country

Slovakia

Facility Name

GSK Investigational Site

City

Bratislava

ZIP/Postal Code

826 06

Country

Slovakia

Facility Name

GSK Investigational Site

City

Nitra

ZIP/Postal Code

949 01

Country

Slovakia

12. IPD Sharing Statement

Learn more about this trial

Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer

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Oral HYCAMTIN Plus Whole Brain Radiation Therapy In Treatment Of Brain Metastases Resulting From Non-Small Lung Cancer

Lung Cancer, Non-Small Cell

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial