Clinical Trial: Carboplatin, Paclitaxel, and Pegfilgrastim in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, Primary Peritoneal, or Carcinosarcoma Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Pe

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 Summary:

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.


Sponsor: Gynecologic Oncology Group

Current Primary Outcome: 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 ]

Original Primary Outcome:

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

Information By: Gynecologic Oncology Group

Dates:
Date Received: July 13, 2006
Date Started: June 2006
Date Completion:
Last Updated: December 29, 2014
Last Verified: December 2014