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Spots Global Cancer Trial Database for Nitrocamptothecin in Treating Patients With Advanced Small Cell Lung Cancer

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Trial Identification

Brief Title: Nitrocamptothecin in Treating Patients With Advanced Small Cell Lung Cancer

Official Title: Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On - 2 Days Off" Oral Treatment in Advanced Small Cell Lung Cancer

Study ID: NCT00006082

Conditions

Lung Cancer

Interventions

rubitecan

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have advanced small cell lung cancer.

Detailed Description: OBJECTIVES: * Determine the objective response and duration of objective response in patients with advanced small cell lung cancer treated with nitrocamptothecin. * Determine the probability of objective response as expressed by the response rate in patients treated with this regimen. * Determine the toxicities of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to disease status (sensitive vs refractory). Patients receive oral nitrocamptothecin daily for 5 consecutive days each week for 3 weeks. Treatment continues every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD) receive up to 4 additional courses past SD. Patients who achieve partial response (PR) or complete response (CR) receive a minimum of 2 additional courses past CR or PR. Patients are followed every 6 weeks until disease progression or initiation of another antitumor treatment. PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for the sensitive disease stratum and a total of 19-24 patients will be accrued for the refractory disease stratum

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

CRLCC Nantes - Atlantique, Nantes-Saint Herblain, , France

Contact Details

Name: Pierre Fumoleau, MD, PhD

Affiliation: Centre Georges Francois Leclerc

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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