Trial of High Dose Topotecan With Carboplatin in Patients With Relapsed Ovarian Carcinoma

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: Female

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. For relapses occurring between 6 and 12 months, no recommendation occur and few studies are conducted. Therefore it seems interesting to develop a research on intensive chemotherapy using a combination of carboplatin (a drug widely used in most ovarian cancer) with Topotecan , use in a high dose protocol. Topotecan has demonstrated its efficacy in relapse ovarian cancer and its possible use in high doses, a recent study (ITOV01) have demonstrated the feasibility of dose escalation of topotecan monotherapy (MTD set at 9 mg / m² / dx 5 days). This project is a feasibility research of the combination of topotecan and carboplatin in a high dose escalation protocol for early ovarian cancer relapse occurring 6 to 12 months after conventional chemotherapy-based platinum salts.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Carboplatin; Topotecan

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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