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Gemcitabine Plus Oxaliplatin in Advanced Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

Primary Purpose

Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Oxaliplatin

Gemcitabine

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Non small cell lung cancer, advanced stage IIIB, Stage IV

Eligibility Criteria

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

Inclusion Criteria:

Histologic or cytologic diagnosis of NSCLC, Stage IV or selected stage IIIB (with positive pleural effusion or separate tumor nodules in the same lobe) according to the American Joint Committee on Cancer (AJCC).
No prior chemotherapy.
Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
No other forms of cancer therapy, such as radiation, immunotherapy for at least 4 weeks before the enrollment in study.
Performance status of 0, 1, 2 on the ECOG criteria.
At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).
Estimated life expectancy of at least 12 weeks.
Patient compliance that allow adequate follow-up.
Adequate organ function including the following:Adequate hematologic function: WBC count ≥ 3,500/uL, absolute neutrophil count (ANC) ≥ 1,500/uL, and platelet count ≥ 100,000/uLAdequate hepatic function: bilirubin ≤ 1.5 x UNL, ALT or AST ≤ 2.5 x UNL.Adequate renal function: creatinine ≤ 1.5mg/dL.
Informed consent from patient
Males or females at least 18 years old.
If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative hCG test within 7 days prior to the study registration.

Exclusion Criteria:

MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia
Serious concomitant infection including post obstructive pneumonia
Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
Pregnant or nursing women
Psychiatric disorder that would preclude compliance.
Major surgery other than biopsy within the past two weeks.

Sites / Locations

National Cancer Center, Korea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

study arm

Arm Description

GemOx

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

To access the toxicity

To estimate the time to progression and overall survival

To evaluate the improvement quality of life

To estimate the overall survival

Full Information

NCT ID

NCT00453115

First Posted

March 27, 2007

Last Updated

October 22, 2010

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT00453115

Brief Title

Gemcitabine Plus Oxaliplatin in Advanced Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

Official Title

A Phase II Study of Gemcitabine Plus Oxaliplatin for Patients With Advanced Stage IIIB or IV Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2006 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Oxaliplatin is a diaminocyclohexane platinum compound, with a mechanism of action similar to that of cisplatin. Oxaliplatin has a more manageable toxicity profile than cisplatin, with no renal toxicity and a lower incidence of hematological and gastrointestinal toxicities. Gemcitabine and oxaliplatin are both active in NSCLC with no overlapping toxicity. Preclinical studies show a synergistic effect of the gemcitabine-oxaliplatin combination. The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic index.

Detailed Description

The combination of gemcitabine-oxaliplatin is attractive in NSCLC patients as it may improve the therapeutic index. We are conducting a phase II study to evaluate the response rate and toxicity of the gemcitabine-oxaliplatin combination both given every 4 weeks in patients with advanced NSCLC.

6. Conditions and Keywords

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

Lung Cancer

Keywords

Non small cell lung cancer, advanced stage IIIB, Stage IV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

study arm

Arm Type

Experimental

Arm Description

GemOx

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

oxaliplatin 85mg/m2 iv on D1 and 15, every 4 weeks until disease progression

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

gemcitabine 1250mg/m2 iv on day 1 and 15, every 4 weeks until disease progression

Primary Outcome Measure Information:

Title

Response rate

Time Frame

every 12 weeks during until disease progression

Secondary Outcome Measure Information:

Title

To access the toxicity

Time Frame

the first day of the treatment to 30 days after the last dose of study drug

Title

To estimate the time to progression and overall survival

Time Frame

the first day of treatment to the date that disease progression is reported

Title

To evaluate the improvement quality of life

Time Frame

before the first treatment and every cycle d1 until diseas progression

Title

To estimate the overall survival

Time Frame

the first day of the treatment to death date

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologic or cytologic diagnosis of NSCLC, Stage IV or selected stage IIIB (with positive pleural effusion or separate tumor nodules in the same lobe) according to the American Joint Committee on Cancer (AJCC). No prior chemotherapy. Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease. No other forms of cancer therapy, such as radiation, immunotherapy for at least 4 weeks before the enrollment in study. Performance status of 0, 1, 2 on the ECOG criteria. At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000). Estimated life expectancy of at least 12 weeks. Patient compliance that allow adequate follow-up. Adequate organ function including the following:Adequate hematologic function: WBC count ≥ 3,500/uL, absolute neutrophil count (ANC) ≥ 1,500/uL, and platelet count ≥ 100,000/uLAdequate hepatic function: bilirubin ≤ 1.5 x UNL, ALT or AST ≤ 2.5 x UNL.Adequate renal function: creatinine ≤ 1.5mg/dL. Informed consent from patient Males or females at least 18 years old. If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative hCG test within 7 days prior to the study registration. Exclusion Criteria: MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia Serious concomitant infection including post obstructive pneumonia Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence) Pregnant or nursing women Psychiatric disorder that would preclude compliance. Major surgery other than biopsy within the past two weeks.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heung Tae Kim, M.D.

Organizational Affiliation

National Cancer Center, Korea

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cancer Center, Korea

City

Goyang-si

State/Province

Gyeonggi-dog

ZIP/Postal Code

411-769

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Gemcitabine Plus Oxaliplatin in Advanced Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)

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