TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Telik
ClinicalTrials.gov Identifier:
NCT00102973
First received: February 4, 2005
Last updated: May 30, 2012
Last verified: June 2006
  Purpose

The purpose of this research study is to determine if TLK286 given in combination with carboplatin is more effective than liposomal doxorubicin in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer, that is refractory or resistant to platinum chemotherapy.


Condition Intervention Phase
Ovarian Neoplasms
Drug: TLK286 in Combination with Carboplatin
Drug: Doxorubicin HCl Liposome Injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Liposomal Doxorubicin (Doxil) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-3]

Resource links provided by NLM:


Further study details as provided by Telik:

Primary Outcome Measures:
  • Study Objectives [ Time Frame: Every 8 Weeks ] [ Designated as safety issue: Yes ]
    To demonstrate superiority in the objective response rate (ORR) of TLK286 in combination with carboplatin as compared to active control therapy with liposomal doxorubicin


Enrollment: 244
Study Start Date: December 2004
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TLK286 in Combination with Carboplatin Drug: TLK286 in Combination with Carboplatin
Experimental Arm
Active Comparator: Doxorubisin HCl Liposome Injection Drug: Doxorubicin HCl Liposome Injection
Active Comparator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are a woman 18 years of age or older
  • Have histologically or cytologically confirmed epithelial cancer of the ovary or fallopian tube, or primary peritoneal cancer
  • Have platinum refractory or resistant cancer
  • Measurable disease according to radiographic RECIST criteria with documented tumor progression

Exclusion Criteria:

  • Had treatment with first-line chemotherapy other than platinum-based regimens (carboplatin or cisplatin)
  • Have clinically significant cardiac disease
  • Have any sign of intestinal obstruction interfering with nutrition at the time of study entry
  • Are pregnant or lactating
  • Had prior treatment with liposomal doxorubicin for ovarian cancer
  • Had prior treatment with TLK286
  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: NCT00102973

  Show 222 Study Locations
Sponsors and Collaborators
Telik
  More Information

No publications provided

Responsible Party: Telik
ClinicalTrials.gov Identifier: NCT00102973     History of Changes
Other Study ID Numbers: TLK286.3024
Study First Received: February 4, 2005
Last Updated: May 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Telik:
Ovary

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Doxorubicin
Liposomal doxorubicin
Carboplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014