Carboplatin, Paclitaxel, and Pegfilgrastim in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, Primary Peritoneal, or Carcinosarcoma 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.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Procedure: adjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Number of patients who have ≥ 1 dose-limiting toxicity during 6 courses of treatment [ Designated as safety issue: Yes ]
- Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale [ Designated as safety issue: Yes ]
- Frequency and duration of objective response (complete and partial response) [ Designated as safety issue: No ]
- Grade of toxicity as assessed by CTCAE V3.0 [ Designated as safety issue: Yes ]
|Study Start Date:||June 2006|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
- Establish the feasibility of adjuvant dose-dense carboplatin and paclitaxel followed by pegfilgrastim, in terms of absence of grade 3 or 4 nonhematologic toxicities without major dose delays or additional hematological support (e.g., red blood cell or platelet transfusions or admission for febrile neutropenia), in patients with stage III-IV ovarian epithelial, fallopian tube, primary peritoneal cancer, or carcinosarcoma cancer.
- Estimate the percentage of patients who develop ≥ grade 2 peripheral neurotoxicity from this regimen.
- Estimate the clinical response rate in patients with measurable disease treated with this regimen.
- Assess the toxicity of this regimen.
OUTLINE: This is a multicenter study.
Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352300
|United States, California|
|Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center|
|Orange, California, United States, 92868|
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242-1002|
|United States, New York|
|NYU Cancer Institute at New York University Medical Center|
|New York, New York, United States, 10016|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210-1240|
|Riverside Methodist Hospital Cancer Care|
|Columbus, Ohio, United States, 43214-3998|
|United States, Oklahoma|
|Oklahoma University Cancer Institute|
|Oklahoma City, Oklahoma, United States, 73104|
|Cancer Care Associates - Saint Francis Campus|
|Tulsa, Oklahoma, United States, 74136-1929|
|United States, Rhode Island|
|Women and Infants Hospital of Rhode Island|
|Providence, Rhode Island, United States, 02905|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98104|
|University Cancer Center at University of Washington Medical Center|
|Seattle, Washington, United States, 98195-6043|
|Study Chair:||Amy D. Tiersten, MD||New York University School of Medicine|
|Study Chair:||Agustin Garcia, MD||Premiere Oncology|
|Study Chair:||Franco M. Muggia, MD||New York University School of Medicine|