CT-2106 for the Second Line Treatment of Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Phase II Open Label Study of CT-2106 as a Single Agent in Patients With Advanced Metastatic Ovarian Cancer Who Have Failed One Prior Platinum and Taxane Based Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291837
• Other study ID #: CAM203
• Status: Completed
• Phase: Phase 2
• First received: February 14, 2006
• Last updated: February 24, 2010
• Start date: November 2004
• Est. completion date: December 2007

Study information

• Verified date: February 2010
• Source: CTI BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2007
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• CT-2106

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CTI BioPharma

Countries where clinical trial is conducted

France,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate
Secondary	toxicity
Secondary	response duration
Secondary	time to progression
Secondary	survival