Combination Paclitaxel, Carboplatin and Temozolomide

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Combination Treatment - Cohort 1

Combination Treatment - Cohort 2

Combination Treatment - Cohort 3

Combination Treatment - Cohort 4

About this trial

This is an interventional treatment trial for Lung Diseases focused on measuring Extensive or recurrent small cell lung cancer Phase I, Paclitaxel, Carboplatin, Temozolomide

Eligibility Criteria

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

Inclusion Criteria: Age greater than or equal to 18 years Karnofsky performance status (KPS) of greater than or equal to 70 (Appendix B) Laboratory values (performed within 14 days prior to study drug administration, inclusive). Absolute neutrophil count (ANC) >1500/mm3 Platelet count >100,000/mm3 Hemoglobin >10 g/dl or 100 g/l BUN and serum creatinine <1.5 times upper limit of laboratory normal Total and direct bilirubin <1.5 times upper limit of laboratory normal SGOT and SGPT <3 times upper limit of laboratory normal Alkaline Phosphatase <3 times upper limit of laboratory normal A life expectancy of greater than 12 weeks Subjects must give written informed consent. Biopsy proven small cell lung cancer. CT of chest, abdomen, pelvis and MRI of head Patients with brain metastases should be asymptomatic to enter the study Exclusion Criteria: No recovery from all active toxicities of prior therapies. Subjects who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics. Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction). Concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin. Prior malignancies which have not required anti-tumor treatment within the preceding 24 months are eligible. Known HIV positivity or AIDS-related illness. Pregnant or nursing women. Women of childbearing potential who are not using an effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions. Men who are not advised to use an effective method of contraception. Progression of disease on prior chemotherapy with paclitaxel and carboplatin, either as single agent or in combination. Known hypersensitivity reaction to taxoid or platinum compound.

Sites / Locations

University of New Mexico Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination Treatment

Arm Description

Paclitaxel at 175 mg/m2 + Carboplatin at area under the curve (AUC) 5 on day 1. Then, Temozolomide at the doses described under "Interventions" from day 2 to day 6 (a total of 5 days). Cycle length is 21 days.

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose of Temozolomide in Combination with Fixed Doses of Paclitaxel and Carboplatin

Temozolomide was administered at different dose levels (see Cohorts 1-4) until the maximum tolerated dose (MTD) was reached. MTD is the dose at which 0/6 or 1/6 patients in the cohort experience dose limiting toxicity (DLT) during the first 4 week cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing DLT. DLT will have occurred when the patient has 1 or more Grade 4 hematologic or nonhematologic toxicities. A DLT must occur in the first cycle of the combination and must be at least possibly attributed to the treatment regimen. Toxicities will be graded according to the NCI CTCAE Version 3.0.

Secondary Outcome Measures

Tumor response rate

Tumor response is evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 as determined by the investigator. Complete response (CR): Disappearance of all evidence of target and non-target lesions. Partial response (P): >= 30% reduction from baseline in the sum of the longest diameter of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. Stable Disease (SD): Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. Progressive disease (PD) for target lesions: >= 20% increase in the sum of diameters of the target lesions taking as reference the smallest sum on study, and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered . PD for non-target lesions is defined as unequivocal appearance of one or more new malignant lesions or unequivocal progression of existing non-target lesions.

Full Information

NCT ID

NCT00249964

First Posted

November 3, 2005

Last Updated

January 15, 2016

Sponsor

New Mexico Cancer Care Alliance

1. Study Identification

Unique Protocol Identification Number

NCT00249964

Brief Title

Combination Paclitaxel, Carboplatin and Temozolomide

Official Title

Phase I Dose Finding Clinical Trial of Combination Paclitaxel, Carboplatin and Temozolomide for Subjects With Solid Tumor Malignancies.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

November 2003 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

New Mexico Cancer Care Alliance

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the maximum tolerable dose of temozolomide in combination with fixed dose of paclitaxel and carboplatin and to determine the overall tumor response rate with this combination and to determine the duration of response.

Detailed Description

The objective of the research study is to test a combination of drugs to treat small cell lung cancer which has spread beyond the lungs (extensive cancer) or come back after earlier treatment (recurrent cancer).

6. Conditions and Keywords

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

Lung Diseases, Cancer

Keywords

Extensive or recurrent small cell lung cancer Phase I, Paclitaxel, Carboplatin, Temozolomide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Combination Treatment

Arm Type

Experimental

Arm Description

Paclitaxel at 175 mg/m2 + Carboplatin at area under the curve (AUC) 5 on day 1. Then, Temozolomide at the doses described under "Interventions" from day 2 to day 6 (a total of 5 days). Cycle length is 21 days.

Intervention Type

Drug

Intervention Name(s)

Combination Treatment - Cohort 1

Other Intervention Name(s)

Paraplatin (Carboplatin), Taxol (Paclitaxel), Temodar (Temozolomide)

Intervention Description

Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1. Temozolomide at 75 mg/m2 per day from day 2 to day 6.

Intervention Type

Drug

Intervention Name(s)

Combination Treatment - Cohort 2

Other Intervention Name(s)

Paraplatin (Carboplatin), Taxol (Paclitaxel), Temodar (Temozolomide)

Intervention Description

Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1. Temozolomide at 100 mg/m2 per day from day 2 to day 6.

Intervention Type

Drug

Intervention Name(s)

Combination Treatment - Cohort 3

Other Intervention Name(s)

Paraplatin (Carboplatin), Taxol (Paclitaxel), Temodar (Temozolomide)

Intervention Description

Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1. Temozolomide at 125 mg/m2 per day from day 2 to day 6.

Intervention Type

Drug

Intervention Name(s)

Combination Treatment - Cohort 4

Other Intervention Name(s)

Paraplatin (Carboplatin), Taxol (Paclitaxel), Temodar (Temozolomide)

Intervention Description

Paclitaxel at 175 mg/m2 intravenously + Carboplatin at AUC 5 intravenously on day 1. Temozolomide at 150 mg/m2 per day from day 2 to day 6.

Primary Outcome Measure Information:

Title

Maximum Tolerated Dose of Temozolomide in Combination with Fixed Doses of Paclitaxel and Carboplatin

Description

Temozolomide was administered at different dose levels (see Cohorts 1-4) until the maximum tolerated dose (MTD) was reached. MTD is the dose at which 0/6 or 1/6 patients in the cohort experience dose limiting toxicity (DLT) during the first 4 week cycle with the next higher dose having at least 2/3 or 2/6 patients experiencing DLT. DLT will have occurred when the patient has 1 or more Grade 4 hematologic or nonhematologic toxicities. A DLT must occur in the first cycle of the combination and must be at least possibly attributed to the treatment regimen. Toxicities will be graded according to the NCI CTCAE Version 3.0.

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Tumor response rate

Description

Tumor response is evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0 as determined by the investigator. Complete response (CR): Disappearance of all evidence of target and non-target lesions. Partial response (P): >= 30% reduction from baseline in the sum of the longest diameter of all lesions. CR and PR criteria should be met again after 4 weeks and before 6 weeks after initial assessment. Stable Disease (SD): Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. Progressive disease (PD) for target lesions: >= 20% increase in the sum of diameters of the target lesions taking as reference the smallest sum on study, and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered . PD for non-target lesions is defined as unequivocal appearance of one or more new malignant lesions or unequivocal progression of existing non-target lesions.

Time Frame

7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Age greater than or equal to 18 years Karnofsky performance status (KPS) of greater than or equal to 70 (Appendix B) Laboratory values (performed within 14 days prior to study drug administration, inclusive). Absolute neutrophil count (ANC) >1500/mm3 Platelet count >100,000/mm3 Hemoglobin >10 g/dl or 100 g/l BUN and serum creatinine <1.5 times upper limit of laboratory normal Total and direct bilirubin <1.5 times upper limit of laboratory normal SGOT and SGPT <3 times upper limit of laboratory normal Alkaline Phosphatase <3 times upper limit of laboratory normal A life expectancy of greater than 12 weeks Subjects must give written informed consent. Biopsy proven small cell lung cancer. CT of chest, abdomen, pelvis and MRI of head Patients with brain metastases should be asymptomatic to enter the study Exclusion Criteria: No recovery from all active toxicities of prior therapies. Subjects who are poor medical risks because of non-malignant systemic disease as well as those with acute infection treated with intravenous antibiotics. Frequent vomiting or medical condition that could interfere with oral medication intake (eg, partial bowel obstruction). Concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin. Prior malignancies which have not required anti-tumor treatment within the preceding 24 months are eligible. Known HIV positivity or AIDS-related illness. Pregnant or nursing women. Women of childbearing potential who are not using an effective method of contraception. Women of childbearing potential must have a negative serum pregnancy test 24 hours prior to administration of study drug and be practicing medically approved contraceptive precautions. Men who are not advised to use an effective method of contraception. Progression of disease on prior chemotherapy with paclitaxel and carboplatin, either as single agent or in combination. Known hypersensitivity reaction to taxoid or platinum compound.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fa-Chyi Lee, MD

Organizational Affiliation

University of New Mexico

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of New Mexico Cancer Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Lung Diseases, Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

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