Study:
A Phase II Evaluation of Docetaxel (NSC #628503) Plus Trabectedin (Yondelis®), R279741, IND # Pending) With Growth Factor Support in the Third-Line Treatment of Recurrent or Persistent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
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.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer |
Biological: filgrastim
Biological: pegfilgrastim
Drug: docetaxel
Drug: trabectedin |
Phase 2 |
Verified by
Gynecologic Oncology Group
June, 2009
Sponsored by: Gynecologic Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00569673
Study Type: Interventional
Study Design: Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio 44111
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Bradley J. Monk, MD., Study Chair
Kristine M. Zanotti, MD.,