Neutropenia Clinical Trial
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
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.
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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