Status:
COMPLETED
Irinotecan and Carboplatin in Treating Patients With Metastatic or Recurrent Small Cell Lung Cancer
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
National Cancer Institute (NCI)
Pfizer
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Givi...
Detailed Description
OBJECTIVES: * Determine the response rates in patients with metastatic or recurrent small cell lung cancer treated with irinotecan hydrochloride and carboplatin. * Determine the median survival of pa...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer, meeting 1 of the following criteria:
- Previously untreated metastatic or extensive disease
- Malignant pleural effusion or multifocal lung disease is considered metastatic or extensive disease
- Prior radiotherapy allowed
- Recurrent disease
- Limited, metastatic, or extensive disease
- Relapsed after prior chemotherapy, excluding irinotecan hydrochloride
- At least 90 days since prior chemotherapy
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 1 cm by physical examination or radiographic techniques
- Known brain metastases allowed
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 3 months
- White Blood Cells \> 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- Bilirubin ≤ 1.5 mg/dL
- SGOT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No medical disease that, in the opinion of the investigator, would preclude study treatment
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 10 days since prior radiotherapy (including brain)
- No prior irinotecan hydrochloride
- At least 2 weeks since prior and no concurrent anticonvulsants
- No concurrent radiotherapy
Exclusion
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00387660
Start Date
October 1 2001
End Date
January 1 2009
Last Update
January 10 2018
Active Locations (1)
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1
University of California Davis Cancer Center
Sacramento, California, United States, 95817