Irinotecan and Carboplatin as First-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Carboplatin; irinotecan hydrochloride
Intervention description: Carboplatin dosage calculation to be given on day 1, every 21 days:
Carboplatin (mg) = (AUC of 5) x (GFR + 25)
*up to 6 cycles at physician's discretion; 50 mg/m2 IV on days 1 and 8 every 21 days
Should be infused IV over 30- 90 minutes.
Intervention MeSH terms: Carboplatin; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: extensive stage small cell lung cancer

Summary:

      RATIONALE: The general results of combining irinotecan and platin-based chemotherapies have
      been very encouraging. As the toxicity profile associated with carboplatin is preferable over
      cisplatin it is our expectation that patients and physicians would prefer to use this
      combination if it is equally or more efficacious. To date there has been no agreement
      regarding the optimal combination of these agents. Based on the trials described in the
      protocol and our experience with carboplatin/irinotecan in the treatment of non-small cell
      lung cancer the present trial will utilize a 21-day cycle of irinotecan 50 mg/m2 given on
      days 1 and 8 and carboplatin AUC 5 (based on the Calvert formula) on day 1.

      PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin
      works as first-line therapy in treating patients with extensive-stage small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed small cell lung cancer (SCLC)

               -  Extensive stage small cell lung cancer

          -  Must have ≥ 1 unidimensionally measurable lesion (longest diameter to be recorded) ≥
             20 mm by conventional techniques or ≥ 10 mm by spiral CT scan

               -  Lesion cannot be from a previously irradiated area

               -  Lesions that are considered nonmeasurable include the following:

                    -  Bone lesions

                    -  Leptomeningeal disease

                    -  Ascites

                    -  Pleural/pericardial effusion

                    -  Lymphangitis cutis/pulmonis

                    -  Abdominal masses not confirmed and followed by imaging techniques

                    -  Cystic lesions

                    -  Tumor lesions in a previously irradiated area

          -  No brain metastasis or carcinomatous meningitis unless stable and asymptomatic

        PATIENT CHARACTERISTICS

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 3 months

          -  ANC ≥ 1,500/mm³

          -  Platelet count > 100,000/mm³

          -  Serum bilirubin ≤ 1.5 mg/dL

          -  AST/SGOT ≤ 2.5 times upper limit of normal (ULN) (or ≤ 5 times ULN if liver metastases
             present)

          -  Serum creatinine ≤ 2.0 mg/dl

          -  Hemoglobin ≥ 9.0 g/dl

        Exclusion Criteria:

          -  CNS metastasis excluded unless: stable and asymptomatic

          -  Coexisting medical condition that would preclude study compliance

          -  Patients with Gilbert's disease

          -  Uncontrolled diabetes mellitus, defined as random blood sugar ≥ 300 mg/dl or > 16.6
             mmol/L

          -  Patients who do not discontinue phenytoin, phenobarbitol, carbamazipine, or other
             enzyme-inducing anticonvulsant drugs at least 7 days prior to first treatment dose on
             study. Gabapentin is permitted

          -  Patients who do not discontinue St. John's Wort prior to first treatment dose on
             study.

          -  Patients who are pregnant or breast feeding

          -  Concomitant second active malignancy except for any in situ cancer or adequately
             treated basal cell or squamous cell skin cancer or any cancer from which the patients
             has been disease-free for at least 2 years

          -  No administration of any prior systemic anticancer therapy for extensive stage SCLC
             such as: chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy,
             cytokine therapy, or other experimental agents. Concurrent use of other anticancer
             therapy including inhibitors of vascular endothelial or epidermal growth factor
             pathways is prohibited. Prior radiation is allowed

          -  Symptomatic brain metastasis or carcinomatous meningitis

        PRIOR CONCURRENT THERAPY: