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A Phase II Trial of VInflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Carcinoma, Small Cell, Lung Cancer

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Trial Information

A Phase II Trial of VInflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer

Eligible patients will receive vinflunine as a 15-20 minute intravenous (IV)infusion once
every three weeks (21 days). This three week treatment period is called a cycle. Patients
whose cancer has not grown or if it has decreased in size may receive up to 6 cycles of
vinflunine. Evaluation will be conducted every other cycle.

Inclusion Criteria:

- Small cell lung cancer with progression after one previous chemotherapy or
chemotherapy/radiation therapy regimen

- Measurable or evaluable disease

- Able to perform activities of daily living with minimal assistance

- Adequate hematological, liver, and kidney function

- Must give written informed consent prior to entry

Exclusion Criteria:

- CNS involvement

- Serious active infection or underlying medical condition

- Significant history of uncontrolled cardiac disease

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 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 criteria 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:

January 2006

Completion Date:

November 2009

Related Keywords:

  • Carcinoma, Small Cell
  • Lung Cancer
  • Extensive stage
  • Relapsed
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell



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