Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
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 ovarian cancer.
|Study Design:||Primary Purpose: Treatment|
|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 Ovarian Cancer|
|Study Start Date:||May 2000|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
- Determine the objective response rate and duration of response in patients with advanced ovarian cancer treated with nitrocamptothecin.
- Determine the probability of objective response as expressed by the response rate in patients treated with this regimen.
- Determine the toxicity 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 PR or CR.
Patients are followed every 6 weeks until disease progression or the initiation of another antitumor therapy.
PROJECTED ACCRUAL: A total of 28-50 patients (14-25 per stratum) will be accrued for this study.
|Institut Jules Bordet|
|Brussels, Belgium, B-1000|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre de Lutte Contre le Cancer, Georges-Francois Leclerc|
|Dijon, France, 21079|
|CHU de la Timone|
|Marseille, France, 13385|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Centre Eugene Marquis|
|Rennes, France, 35042|
|Rabin Medical Center - Beilinson Campus|
|Petah-Tikva, Israel, 49100|
|Azienda Ospedaliera di Padova|
|Padova (Padua), Italy, 35128|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Ospedale San Giovanni|
|Bellinzona, Switzerland, 6500|
|Clinique De Genolier|
|Genolier, Switzerland, Ch-1272|
|Newcastle General Hospital|
|Newcastle Upon Tyne, England, United Kingdom, NE4 6BE|
|Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Study Chair:||Pierre Fumoleau, MD, PhD||Centre de Lutte Contre le Cancer Georges-Francois Leclerc|