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Phase II Study of Irinotecan and Carboplatin in Metastatic or Relapsed Small-Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

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Trial Information

Phase II Study of Irinotecan and Carboplatin in Metastatic or Relapsed Small-Cell Lung Cancer


- 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.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Inclusion Criteria


- 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


- ECOG performance status 0-2

- Life expectancy ≥ 3 months

- WBC > 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

- 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


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

Evidence of disease progression during the study

Safety Issue:


Principal Investigator

Derick H. Lau, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis


United States: Federal Government

Study ID:




Start Date:

October 2001

Completion Date:

January 2009

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • limited stage small cell lung cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



University of California Davis Cancer Center Sacramento, California  95817