Nitrocamptothecin in Treating Patients With Advanced Ovarian Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00006230|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: rubitecan||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|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|
|Actual Primary Completion Date :||April 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006230
|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 Georges Francois Leclerc|