drugset / Trial / NCT00350948
Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2006-05
- Primary completion
- 2008-12
- Completion
- 2008-12
Outcome
Missed primary endpoint
Stopped (Business): “Business reasons”
paper 5.6 months for canfosfamide + PLD (n = 65) versus 3.7 months for PLD (n = 60) (hazards ratio, 0.92; P = 0.7243). PMID 20973267 ↗
paper Overall median PFS showed a positive trend but was not statistically significant. PMID 20973267 ↗
Publications
- Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
- Vergote I, Finkler NJ, Hall JB, Melnyk O, Edwards RP, Jones M, Keck JG, Meng L, Brown GL, Rankin EM, Burke JJ, Boccia RV, Runowicz CD, Rose PG. Randomized phase III study of canfosfamide in combination with pegylated liposomal doxorubicin compared with pegylated liposomal doxorubicin alone in platinum-resistant ovarian cancer. Int J Gynecol Cancer. 2010 Jul;20(5):772-80. doi: 10.1111/igc.0b013e3181daaf59.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Subject | canfosfamide | Small molecule | 1000 mg/m2 | Intravenous |