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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
N/A
Not Enrolling
Both
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:

Interventional

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:

No

Principal Investigator

David R. Spigel, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI LUN 122

NCT ID:

NCT00284154

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

Name

Location
Florida Cancer Specialists Fort Myers, Florida  33901
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
Oncology Hematology Care Cincinnati, Ohio  45242