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:
Information provided by (Responsible Party):
Telik
ClinicalTrials.gov Identifier:
NCT00350948
First received: July 6, 2006
Last updated: November 26, 2013
Last verified: November 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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) ] [ Designated as safety issue: Yes ]

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. ] [ Designated as safety issue: Yes ]

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

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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350948

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

No publications provided by Telik

Additional 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
Study First Received: July 6, 2006
Last Updated: November 26, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Ministry of Social Affairs, Public Health and the Environment
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Brazil: Ministry of Health

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
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014