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Keep this study
Lead
University of California, Davis
With
National Cancer Institute (NCI)
Pfizer
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 patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and disease stage (metastatic vs relapsed).
Patients receive irinotecan hydrochloride IV over 90 minutes and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | Irinotecan and Carboplatin in Treating Patients With Metastatic or Recurrent Small Cell Lung Cancer