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

Completed · Phase 1

Conditions studied: Fallopian Tube Carcinoma, Infectious Disorder, Neutropenia, Ovarian Carcinosarcoma, Primary Peritoneal Carcinoma, Stage III Ovarian Cancer, Stage IV Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT00352300

Run by

Gynecologic Oncology Group

People needed

43

Starts

2006-06-01

Last updated by the study team

2014-12-31

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of 1 of the following:
• Primary peritoneal carcinoma
• Fallopian tube carcinoma
• Ovarian epithelial carcinoma
• Carcinosarcoma
• Stage III or IV disease
• Previously untreated disease, except for mandatory prior surgery
• No ovarian epithelial carcinoma of low malignant potential (i.e., borderline carcinomas)
• GOG performance status 0-2
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• SGOT ≤ 2.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• No peripheral neuropathy (sensory or motor) ≥ grade 2
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
• No septicemia, severe infection, or acute hepatitis
• No prior radiotherapy or chemotherapy
• No prior cancer treatment that would contraindicate study treatment

Where it is running

• 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

Full record on ClinicalTrials.gov

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