Status:
TERMINATED
Trial of High Dose Topotecan With Carboplatin in Patients With Relapsed Ovarian Carcinoma
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Ovarian Cancer
Relapses
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
Brief Summary
The early relapse of ovarian cancer occurring within 6 months of chemotherapy including platinum regimen are called relapses 'platinum resistant' consecutively patients die quickly of their disease. F...
Detailed Description
The combination Topotecan plus carboplatin at high doses has been published by Miles Prince et al in 2001. In a triple combination, the authors were able to define the Maximum Tolerated Dose (MTD) of ...
Eligibility Criteria
Inclusion
- Primary ovarian or tubal adenocarcinoma, or peritoneal carcinoma histologically proved
- Age between 18 and 65
- ECOG criteria £ 2
- Patients with first relapsed ovarian carcinoma without platinum-treatment since 6-12 months and after first-line therapy with platinum salt and taxanes together or successively
- Negative viral serology (HbS, HbC and HIV)
- Informed consent
- Patients with social security
Exclusion
- Refractory (relapse \< 6 months) or sensitive (relapse \> 12 months) relapsed ovarian carcinoma
- Life expectancy \< 3 months
- Previous treatment with pelvic radiography
- Previous treatment with Topotecan or other topoisomer I inhibitor
- Non resolutive intestinal obstruction under symptomatic treatment
- Creatinine \> or equal at 1.25N and/or creatinine clearance \< or equal at 60 ml/mn
- Bilirubin \> 1.25N ; transaminase and alkaline phosphatase \> 2N (3N if hepatic metastases were present)
- Abnormal heart (ultrasound only) (FR \< 30%; FEVG \< 50%)
- White blood cells \< or equal at 4.0 x 109/L, Neutrophils \< or equal at 1.5 x 109/L, platelets \< or equal at 100 x 109/L
- Neuropathy: grade \> or equal at 2
- Epilepsy
- Symptomatic cerebral metastases
- Serious psychiatric pathology
- Uncontrolled serious infection
- Patient that already received peripheral blood stem cell support
- Haematopoeitic growth factors allergy
- More than one line chemotherapy
- Impossibility to use an central veinous access
- Hypersensibility to carboplatin or other platinum containing products
- Participation to an other clinical trial
- Absence of effective contraception
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01177501
Start Date
April 1 2009
End Date
March 1 2012
Last Update
November 19 2012
Active Locations (1)
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1
Frédéric Selle
Paris, France, 75020