Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2009-11-30

Brief Summary

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This clinical trial involves the administration of the chemotherapeutic medication vinflunine. Vinflunine is not approved by the FDA and is experimental in the treatment of extensive small cell lung cancer. The purpose of this research trial is to study the effectiveness of vinflunine in patients with relapsed extensive small cell lung cancer, evaluate the toxicity, and evaluate how long the response to this drug lasts.

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Detailed Description

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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.

Conditions

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Carcinoma, Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.

Group Type EXPERIMENTAL

Vinflunine

Intervention Type DRUG

320mg/m2 every 21 days as a 15-20 minute infusion

Interventions

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Vinflunine

320mg/m2 every 21 days as a 15-20 minute infusion

Intervention Type DRUG

Other Intervention Names

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Javlor

Eligibility Criteria

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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