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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01177501
• Date of registration: 06/08/2010
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Trial of High Dose Topotecan With Carboplatin in Patients With Relapsed Ovarian Carcinoma ITOV04
• Scientific title: Phase I Trial of High-dose Topotecan in Association With Carboplatin, With Peripheral Blood Stem Cell Support in Patients With First Relapsed Ovarian Carcinoma Without Platinum-treatment Since 6-12 Months
• Date of first enrolment: April 2009
• Target sample size: 3
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01177501
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: Frédéric Selle, MD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian Cancer

Relapses

Intervention(s)

Drug: Topotecan

Primary Outcome(s)

Identification of the maximum tolerated dose (MTD) of topotecan at 6 weeks [Time Frame: at 6 weeks after the first administration of topotecan]

Secondary Outcome(s)

Pharmacokinetic of topotecan [Time Frame: At 1 and 5 days after the first administration of topotecan]

The response to therapy [Time Frame: From the first day of the administration of topotecan to 2 years]

Pharmacokinetic of carboplatin [Time Frame: At 1 and 5 days after the first administration of topotecan]

The duration of response and the overall survival [Time Frame: From the first day of the administration of topotecan to 2 years]

Secondary ID(s)

P 050603

Source(s) of Monetary Support

Please refer to primary and secondary sponsors