Irinotecan and Carboplatin in Treating Patients With Metastatic or Recurrent Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: carboplatin; irinotecan
Intervention description: Patients receive 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.; Patients receive irinotecan hydrochloride IV over 90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention MeSH terms: Carboplatin; Irinotecan; Camptothecin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: extensive stage small cell lung cancer; limited stage small cell lung cancer; recurrent small cell lung cancer

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. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin
      works in treating patients with metastatic or recurrent small cell lung cancer.
    

Eligibility criteria:

        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