CT-2106 for the Second Line Treatment of Ovarian Cancer

CTI BioPharma

Status and phase

Completed

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: CT-2106

Study type

Interventional

Funder types

Industry

Identifiers

NCT00291837

CAM203

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.