CT-2106 for the Second Line Treatment of Ovarian Cancer

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CTI BioPharma
• Treatments: Camptothecin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.