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

SCRI Development Innovations

Status and phase: Completed; Phase 2

Conditions: Lung Cancer; Carcinoma, Small Cell

Treatments: Drug: Vinflunine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00284154

SCRI LUN 122

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Intervention

Experimental group

Description:

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

Treatment:

Drug: Vinflunine