Carboplatin, Paclitaxel, and Pegfilgrastim in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, Primary Peritoneal, or Carcinosarcoma Cancer
|Fallopian Tube Carcinoma Infectious Disorder Neutropenia Ovarian Carcinosarcoma Primary Peritoneal Carcinoma Stage III Ovarian Cancer Stage IV Ovarian Cancer||Procedure: Adjuvant Therapy Drug: Carboplatin Drug: Paclitaxel Biological: Pegfilgrastim||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (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 greater than or equal to 1 dose-limiting toxicity, assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) [ Time Frame: 12 weeks ]
- Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale [ Time Frame: Up to 1 year ]
- Frequency and duration of objective response (complete and partial response) assessed by Response Evaluation Criteria for Solid Tumors (RECIST) [ Time Frame: Up to 1 year ]
- Grade of toxicity as assessed by CTCAE v3.0 [ Time Frame: Up to 1 year ]
|Study Start Date:||June 2006|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment (carboplatin, paclitaxel, pegfilgrastim)
Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2.
Procedure: Adjuvant Therapy
Given IVDrug: Paclitaxel
Other Names:Biological: Pegfilgrastim
I. 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.
I. Estimate the percentage of patients who develop ≥ grade 2 peripheral neurotoxicity from this regimen.
II. Estimate the clinical response rate in patients with measurable disease treated with this regimen.
III. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352300
|United States, California|
|University of California Medical Center At Irvine-Orange Campus|
|Orange, California, United States, 92868|
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|United States, New Jersey|
|Cooper Hospital University Medical Center|
|Camden, New Jersey, United States, 08103|
|United States, New York|
|New York University Langone 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|
|Riverside Methodist Hospital|
|Columbus, Ohio, United States, 43214|
|Lake University Ireland Cancer Center|
|Mentor, Ohio, United States, 44060|
|United States, Oklahoma|
|Cancer Care Associates-Midtown|
|Tulsa, Oklahoma, United States, 74104|
|United States, Rhode Island|
|Women and Infants Hospital|
|Providence, Rhode Island, United States, 02905|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Amy Tiersten||Gynecologic Oncology Group|