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

Phase 1

Completed

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

Interventions: Procedure: Adjuvant Therapy
Drug: Carboplatin
Drug: Paclitaxel
Biological: Pegfilgrastim

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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Treatment (carboplatin, paclitaxel, pegfilgrastim)	Pegfilgrastim	Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2.
Treatment (carboplatin, paclitaxel, pegfilgrastim)	Adjuvant Therapy	Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2.
Treatment (carboplatin, paclitaxel, pegfilgrastim)	Carboplatin	Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2.
Treatment (carboplatin, paclitaxel, pegfilgrastim)	Paclitaxel	Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2.

Primary Outcome Measures

Name	Time	Method
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)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale	Up to 1 year
Grade of toxicity as assessed by CTCAE v3.0	Up to 1 year
Frequency and duration of objective response (complete and partial response) assessed by Response Evaluation Criteria for Solid Tumors (RECIST)	Up to 1 year

Locations (11): Cooper Hospital University Medical Center
🇺🇸
Camden, New Jersey, United States
Riverside Methodist Hospital
🇺🇸
Columbus, Ohio, United States
Lake University Ireland Cancer Center
🇺🇸
Mentor, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
🇺🇸
Seattle, Washington, United States
Cancer Care Associates-Midtown
🇺🇸
Tulsa, Oklahoma, United States
Women and Infants Hospital
🇺🇸
Providence, Rhode Island, United States
University of California Medical Center At Irvine-Orange Campus
🇺🇸
Orange, California, United States
University of Iowa Hospitals and Clinics
🇺🇸
Iowa City, Iowa, United States
New York University Langone Medical Center
🇺🇸
New York, New York, United States
University of Washington Medical Center
🇺🇸
Seattle, Washington, United States