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
- 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
- Estimate the percentage of patients who develop ≥ grade 2 peripheral neurotoxicity from
- Estimate the clinical response rate in patients with measurable disease treated with
- 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.
Masking: Open Label, Primary Purpose: Treatment
Number of patients who have ≥ 1 dose-limiting toxicity during 6 courses of treatment
Amy D. Tiersten, MD
New York University School of Medicine
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|Women and Infants Hospital of Rhode Island||Providence, Rhode Island 02905|
|NYU Cancer Institute at New York University Medical Center||New York, New York 10016|
|Riverside Methodist Hospital Cancer Care||Columbus, Ohio 43214|
|University Cancer Center at University of Washington Medical Center||Seattle, Washington 98195|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center||Orange, California 92868|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|Cancer Care Associates - Saint Francis Campus||Tulsa, Oklahoma 74136-1929|