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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (carboplatin, paclitaxel, pegfilgrastim)

Patients receive carboplatin IV and paclitaxel IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously on day 2.

Group Type EXPERIMENTAL

Adjuvant Therapy

Intervention Type PROCEDURE

Carboplatin

Intervention Type DRUG

Given IV

Paclitaxel

Intervention Type DRUG

Given IV

Pegfilgrastim

Intervention Type BIOLOGICAL

Given IV

Interventions

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Adjuvant Therapy

Intervention Type PROCEDURE

Carboplatin

Given IV

Intervention Type DRUG

Paclitaxel

Given IV

Intervention Type DRUG

Pegfilgrastim

Given IV

Intervention Type BIOLOGICAL

Other Intervention Names

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Anzatax TAX Filgrastim SD-01 GCSF-SD01 Neulasta

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Tiersten

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

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University of California Medical Center At Irvine-Orange Campus

Orange, California, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Cooper Hospital University Medical Center

Camden, New Jersey, United States

Site Status

New York University Langone Medical Center

New York, New York, United States

Site Status

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Lake University Ireland Cancer Center

Mentor, Ohio, United States

Site Status

Cancer Care Associates-Midtown

Tulsa, Oklahoma, United States

Site Status

Women and Infants Hospital

Providence, Rhode Island, United States

Site Status

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States