Clinical Trials Logo
  1. Home
  2. Ovarian Neoplasms
  3. NCT00350948

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

Ovarian Neoplasms Clinical Trial

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)

Clinical Trial Summary

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.

Clinical Trial 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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00350948
Study type Interventional
Source Telik
Contact
Status Terminated
Phase Phase 3
Start date May 2006
Completion date December 2008
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Active, not recruiting NCT03648489 - Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma) Phase 2
Active, not recruiting NCT02950064 - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations Phase 1
Completed NCT02569983 - The SOCQER-2 Study Surgery in Ovarian Cancer - Quality of Life Evaluation Research
Withdrawn NCT02243059 - Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer Phase 4
Terminated NCT02055690 - PAZOFOS: Phase Ib and Phase II Trial of Pazopanib +/- Fosbretabulin in Advanced Recurrent Ovarian Cancer Phase 1/Phase 2
Completed NCT01719926 - Phase I Platinum Based Chemotherapy Plus Indomethacin Phase 1
Completed NCT00243685 - Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis Phase 2/Phase 3
Completed NCT00415181 - Pharmacogenomics of Paclitaxel in Ovarian Cancer N/A
Recruiting NCT01789229 - Establishment of a Tumor Bank for Tissue Samples
Completed NCT00069160 - Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer Phase 2
Completed NCT00772863 - Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer Phase 2
Completed NCT00046800 - Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer Phase 2
Completed NCT00035100 - EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer Phase 2
Terminated NCT00034372 - Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-Chemotherapy Consolidation for Ovarian Carcinoma Phase 2
Completed NCT00001272 - A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients Phase 1
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Phase 2
Recruiting NCT05001282 - A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRĪ±) Phase 1/Phase 2
Completed NCT02227654 - Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors N/A
Not yet recruiting NCT04055038 - Efficacy of Platinum-based Chemotherapy in Platinum-resistant Ovarian Cancer) (EPITOC) Phase 2/Phase 3