Status:
COMPLETED
CT-2106 for the Second Line Treatment of Ovarian Cancer
Lead Sponsor:
CTI BioPharma
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this sudy is to determine the response rate of CT-2106 in patients with advanced ovarian cancer who have failed one prior platinum and taxane based regimen.
Eligibility Criteria
Inclusion
- Patients with advanced ovarian carcinoma, who have failed one prior platinum and taxane containing regimen
- Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes administered concomitantly
- At least one measurable lesion according to RECIST
- ECOG performance status 0 or 1
- at least 18 years old
- Adequate haematological function
- Adequate renal and hepatic functions
- Normal coagulation parameters
Exclusion
- Platinum-sensitive patients (Group 2) who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval of \> 12 months
- Pregnant or lactating patients
- Prior treatment with camptothecins
- Presence or history of CNS metastasis or carcinomatous leptomeningitis;
- Current active infection per investigator assessment;
- Unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis;
- Current history of chronic diarrhea \>= grade 1 (CTCAE version 3);
- Surgery or radiotherapy ≤ 4 weeks before first study treatment. In case of cytoreductive surgery for the progression of the disease, ≤ 2 weeks before the 1st study treatment are allowed;
- Other uncontrolled, serious illness or medical condition, as determined by the investigator;
- Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation;
- Concurrent treatment with any other anti-cancer therapy;
- Known HIV positivity or AIDS-related illness;
- Patients who cannot be regularly followed up for psychological, social, familial or geographic reasons.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00291837
Start Date
November 1 2004
End Date
December 1 2007
Last Update
February 26 2010
Active Locations (7)
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1
Lyon, France
2
Saint-Brieuc, France
3
Campobasso, Italy
4
Birmingham, United Kingdom