drugset / Trial / NCT00569673
Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer
Open-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with G-CSF or pegfilgrastim may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving docetaxel and trabectedin together with G-CSF or pegfilgrastim works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
Timeline
- Start
- 2008-03
- Primary completion
- 2012-01
- Completion
- —
Publications
- Results Monk BJ, Sill MW, Hanjani P, Edwards R, Rotmensch J, De Geest K, Bonebrake AJ, Walker JL. Docetaxel plus trabectedin appears active in recurrent or persistent ovarian and primary peritoneal cancer after up to three prior regimens: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2011 Mar;120(3):459-63. doi: 10.1016/j.ygyno.2010.11.012. Epub 2010 Dec 7.
- Results Monk, M BJ, Sill M, Walker JL, et al.: Activity of docetaxel plus trabectedin in recurrent or persistent ovarian and primary peritoneal cancer: A phase II study of the Gynecologic Oncology Group (GOG). [Abstract] J Clin Oncol 28 (Suppl 15): A-5046, 2010.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Trabectedin | Small molecule | 1.1 mg/m2 | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | Subcutaneous |
| Background | filgrastim | Protein / enzyme biologic | — | Intravenous |