CT-2106 for the Second Line Treatment of Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by:
CTI BioPharma
ClinicalTrials.gov Identifier:
NCT00291837
First received: February 14, 2006
Last updated: February 24, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: CT-2106
Phase 2

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

Resource links provided by NLM:


Further study details as provided by CTI BioPharma:

Primary Outcome Measures:
  • response rate

Secondary Outcome Measures:
  • toxicity
  • response duration
  • time to progression
  • survival

Estimated Enrollment: 40
Study Start Date: November 2004
Study Completion Date: December 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291837

Locations
France
Lyon, France
Saint Brieuc, France
Italy
Campobasso, Italy
United Kingdom
Birmingham, United Kingdom
London, United Kingdom
Newcastle upon Tyne, United Kingdom
Surrey, United Kingdom
Sponsors and Collaborators
CTI BioPharma
Investigators
Principal Investigator: Hilary Calvert, PhD Newcastle General Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00291837     History of Changes
Other Study ID Numbers: CAM203
Study First Received: February 14, 2006
Last Updated: February 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by CTI BioPharma:
ovarian
CT-2106

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 22, 2014