Spots Global Cancer Trial Database for Carboplatin, Paclitaxel, and Pegfilgrastim in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, Primary Peritoneal, or Carcinosarcoma Cancer
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Trial Identification
Brief Title: Carboplatin, Paclitaxel, and Pegfilgrastim in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, Primary Peritoneal, or Carcinosarcoma Cancer
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
Study ID: NCT00352300
Study Description
Brief Summary: 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. 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.
Detailed Description: PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of California Medical Center At Irvine-Orange Campus, Orange, California, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Cooper Hospital University Medical Center, Camden, New Jersey, United States
New York University Langone Medical Center, New York, New York, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Lake University Ireland Cancer Center, Mentor, Ohio, United States
Cancer Care Associates-Midtown, Tulsa, Oklahoma, United States
Women and Infants Hospital, Providence, Rhode Island, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
Contact Details
Name: Amy Tiersten
Affiliation: Gynecologic Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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