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

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ClinicalTrials.gov Identifier: NCT00102973
Recruitment Status : Completed
First Posted : February 7, 2005
Last Update Posted : May 31, 2012
Sponsor:
Information provided by (Responsible Party):
Telik

Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Neoplasms Drug: TLK286 in Combination with Carboplatin Drug: Doxorubicin HCl Liposome Injection Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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]
Study Start Date : December 2004
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008


Arm Intervention/treatment
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




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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102973


  Show 222 Study Locations
Sponsors and Collaborators
Telik

Responsible Party: Telik
ClinicalTrials.gov Identifier: NCT00102973     History of Changes
Other Study ID Numbers: TLK286.3024
First Posted: February 7, 2005    Key Record Dates
Last Update Posted: May 31, 2012
Last Verified: June 2006

Keywords provided by Telik:
Ovary

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
Liposomal doxorubicin
Carboplatin
Doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action