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Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)

This study has been terminated.
(Business reasons)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00350948
First Posted: July 11, 2006
Last Update Posted: November 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Telik
  Purpose
The purpose of this research study is to determine if Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone 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: Telcyta Drug: Liposomal Doxorubicin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Randomized Study of TLK286 (Telcyta®) in Combination With Liposomal Doxorubicin (Doxil/Caelyx)Versus Liposomal Doxorubicin (Doxil/Caelyx) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)

Resource links provided by NLM:


Further study details as provided by Telik:

Primary Outcome Measures:
  • To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin [ Time Frame: Once 244 planned pts. received at least 2 cycles of study treatment(s) ]

Secondary Outcome Measures:
  • To evaluate and compare the safety profile of each treatment arm [ Time Frame: Any patient who received 1 dose of study treatment(s) will be evaluable for safety. ]

Enrollment: 244
Study Start Date: May 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telcyta + Liposomal Doxorubicin
Telcyta at 1000 mg/m2 followed by Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
Drug: Telcyta
Day 1 of 28 day Cycle.
Other Names:
  • TLK286
  • canfosfamide
Drug: Liposomal Doxorubicin
Day 1 of 28 Day Cycle. 50 mg/m2
Other Names:
  • Doxil
  • Caelyx
Active Comparator: Liposomal Doxorubicin
Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
Drug: Liposomal Doxorubicin
Day 1 of 28 Day Cycle. 50 mg/m2
Other Names:
  • Doxil
  • Caelyx

Detailed Description:
This is a randomized, open label, multicenter, multinational Phase 3 study of TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) as compared to the active control therapy with liposomal doxorubicin (Doxil/Caelyx) as second line therapy in patients with platinum refractory or resistant recurrent ovarian cancer. Patients will be randomly assigned to receive either TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) or active control liposomal doxorubicin (Doxil/Caelyx).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 or primary peritoneal cancer
  • Have platinum refractory or resistant cancer
  • Measurable disease according to radiographic RECIST criteria progression

Exclusion Criteria:

  • Had treatment with first-line chemotherapy other than a platinum-containing regimen
  • Have clinically significant cardiac disease
  • Have any sign of intestinal obstruction interfering with nutrition
  • Are pregnant or lactating
  • Had prior treatment with liposomal doxorubicin
  • Had prior treatment with Telcyta
  Contacts and Locations
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): NCT00350948


  Show 71 Study Locations
Sponsors and Collaborators
Telik
Investigators
Study Director: Gail L. Brown, MD, MBA Telik
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Telik
ClinicalTrials.gov Identifier: NCT00350948     History of Changes
Other Study ID Numbers: TLK286.3025
First Submitted: July 6, 2006
First Posted: July 11, 2006
Last Update Posted: November 27, 2013
Last Verified: November 2013

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