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A Phase II Trial of Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Carcinoma, Small Cell

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Trial Information

A Phase II Trial of Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Eligible patients will receive treatment with carboplatin and topotecan.

Topotecan 4mg/m2 IV on days 1, 8.

Carboplatin AUC=5 IV day 1 only .

- Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6
courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

Outcome Description:

Overall response rate is the percent of patients experiencing a complete or partial response by RECIST v. 1 Criteria. Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response category assigned represented the best response obtained during treatment.

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

David R. Spigel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

March 2006

Completion Date:

November 2009

Related Keywords:

  • Carcinoma, Small Cell
  • Lung Cancer
  • Carcinoma, Small Cell
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell



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