Study:
A Phase I Trial of Dose Dense (Biweekly) Carboplatin Combined With Paclitaxel and Pegfilgrastim (Neulasta): A Feasibility Study in Patients With Untreated Stage III and IV Ovarian, Tubal or Primary Peritoneal Cancer
Rationale:
Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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 pegfilgrastim, may increase the number of
immune cells found in bone marrow or peripheral blood and may help the immune system recover
from the side effects of chemotherapy. Giving carboplatin and paclitaxel together with
pegfilgrastim after surgery may kill any tumor cells that remain after surgery.
Purpose:
This phase I trial is studying the side effects of giving carboplatin and paclitaxel
together with pegfilgrastim in treating patients with stage III or stage IV ovarian
epithelial, fallopian tube, primary peritoneal, or carcinosarcoma cancer.
Study Status: Recruiting
Recruiting:
Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100
| Condition |
Intervention |
Phase |
Fallopian Tube Cancer
Infection
Neutropenia
Ovarian Cancer
Peritoneal Cavity Cancer |
Drug: carboplatin
Drug: paclitaxel
Drug: pegfilgrastim
Procedure: adjuvant therapy |
Phase 1 |
Verified by
Gynecologic Oncology Group
August, 2008
Sponsored by: Gynecologic Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00352300
Study Type: Interventional
Study Design: Treatment, Open Label
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Amy D. Tiersten, MD., Study Chair
Agustin Garcia, MD.,
Franco M. Muggia, MD.,