Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer
Condition: Carcinoma, Small Cell
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Small Cell
Intervention: Topotecan; carboplatin
Intervention description: Topotecan 4mg/m2 IV on days 1, 8.; Carboplatin AUC=5 IV day 1 only .
Intervention MeSH terms: Carboplatin; Topotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung Cancer; Carcinoma, Small Cell

Summary:

      This proposed phase II trial will investigate the combination of topotecan/carboplatin in the
      first-line treatment of patients with extensive-stage SCLC. Topotecan/platinum regimens are
      emerging as common treatments for patients with extensive-stage disease. This trial will be
      one of the first clinical trials to evaluate a combination of weekly topotecan and
      carboplatin in the first-line treatment of extensive-stage SCLC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have confirmed small cell lung cancer with extensive stage disease. This
             includes patients with stage IIIB and IV disease.

          -  Patients with small cell histology are eligible. Large neuroendocrine or mixed small
             cell and non-small cell histology are not eligible.

          -  Patients must have measurable or evaluable disease.

          -  ECOG performance status 0 or 1.

          -  Patients must have adequate bone marrow, liver and kidney function

          -  The patients may have had no previous chemotherapy.

          -  Patients must be able to understand the nature of the study and give written informed
             consent.

        Exclusion Criteria:

          -  Patients with limited stage disease. This includes IA, IB, IIA, IIB, and IIIA.

          -  Age < 18 years old.

          -  History of a prior malignancy within three years with the exception of skin cancer
             (excluding melanoma), cervical carcinoma in situ, in situ breast carcinoma or stage
             A/B prostate cancer.

          -  Female patients who are pregnant or are breast feeding

          -  History of acute myocardial infarction or stroke within 6 months.

          -  Uncontrolled hypertension, unstable angina, New York Heart Association grade II or
             greater CHF, serious cardiac arrhythmia requiring medication, or grade II or greater
             peripheral vascular disease.

          -  Patients who have received other investigational drugs within 28 days.

          -  Patients with CNS involvement (brain or meningeal). The single exception to this is
             the patient previously treated for brain metastases with radiation therapy, or
             surgical excision who has no evidence of active residual metastases on brain MRI at
             the time of study entry.

          -  Patients with large neuroendocrine tumor or mixed small cell and non-small cell
             histology