NCT00006082

Nitrocamptothecin in Treating Patients With Advanced Small Cell Lung Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	rubitecan

Timeline

• Start date: 2000-05-01
• Primary completion: 2002-08-01
• First posted: 2003-05-22
• Last updated: 2012-09-24

Locations

1 site across 1 country: France