Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
- Conditions
- Ovarian Cancer
- Registration Number
- NCT00006230
- 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 ovarian cancer.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 51
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Institut Jules Bordet
🇧🇪Brussels, Belgium
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Ospedale San Giovanni
🇨ðŸ‡Bellinzona, Switzerland
Clinique De Genolier
🇨ðŸ‡Genolier, Switzerland
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
CHU de la Timone
🇫🇷Marseille, France
Rabin Medical Center - Beilinson Campus
🇮🇱Petah-Tikva, Israel
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
🇫🇷Dijon, France
CRLCC Nantes - Atlantique
🇫🇷Nantes-Saint Herblain, France
Azienda Ospedaliera di Padova
🇮🇹Padova (Padua), Italy
Newcastle General Hospital
🇬🇧Newcastle Upon Tyne, England, United Kingdom
Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom