CT-2106 for the Second Line Treatment of Ovarian Cancer

Phase 2

Completed

• Conditions: Ovarian Cancer

• Registration Number: NCT00291837
• Lead Sponsor: CTI BioPharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2006-02-14
• Study First Submitted QC: 2006-02-14
• Study First Posted: 2006-02-15
• Primary Completion: 2006-06
• Study Completion: 2007-12
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-24
• Last Update Posted: 2010-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
response rate

Secondary Outcome Measures

Name	Time	Method
toxicity
response duration
time to progression
survival