Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug and giving them in different ways may
      kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining topotecan, carboplatin, and
      etoposide in treating patients who have extensive-stage small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the toxicity profile and maximum tolerated dose of sequential topotecan,
           carboplatin, and etoposide in patients with chemotherapy-naive extensive stage small
           cell lung cancer. (Phase I closed to accrual as of 04/04/2003).

        -  Determine the response rate and duration of response in patients with treated with this
           regimen.

        -  Determine the failure-free and overall survival of patients treated with this regimen.

        -  Determine the pharmacokinetics and pharmacodynamics of topotecan and etoposide on this
           schedule in these patients.

      OUTLINE: This is a dose-escalation, multicenter study of topotecan and etoposide. (Phase I
      closed to accrual as of 04/04/2003).

      Patients receive oral topotecan on days 1-5, carboplatin IV over 30 minutes on day 6, and
      oral etoposide on days 6-10. Treatment continues every 3 weeks for 2 courses in the absence
      of disease progression or unacceptable toxicity. Patients with complete response (CR) or
      partial response after the second course receive up to 4 additional courses. Patients with
      brain metastases at initial presentation undergo whole-brain irradiation before the
      chemotherapy regimen. Patients without brain metastases at initial presentation who achieve
      CR undergo prophylactic whole-brain irradiation.

      Sequential dose escalation of topotecan is followed by sequential dose escalation of
      etoposide. Cohorts of 3-6 patients receive escalating doses of topotecan and then etoposide
      until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined
      as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting
      toxicity. (Phase I closed to accrual as of 04/04/2003). In the phase II part of study, an
      additional 11-40 patients are accrued to receive topotecan, carboplatin, and etoposide at the
      MTD.

      Patients are followed every 3 months.

      PROJECTED ACCRUAL: A maximum of 50 patients (3-10 for phase I and 11-40 for phase II) will be
      accrued for this study. (Phase I closed to accrual as of 04/04/2003)
    

Intervention name(s): carboplatin; etoposide; topotecan hydrochloride; radiation therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention MeSH terms: Carboplatin; Etoposide; Topotecan
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: extensive stage small cell lung cancer