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

Sponsor

Gynecologic Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00352300

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

3.9

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fallopian Tube Carcinoma Infectious Disorder Neutropenia Ovarian Carcinosarcoma Primary Peritoneal Carcinoma Stage III Ovarian Cancer Stage IV Ovarian Cancer	Procedure: Adjuvant Therapy Drug: Carboplatin Drug: Paclitaxel Biological: Pegfilgrastim	Phase 1

Detailed Description

PRIMARY OBJECTIVES:

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:

Estimate the percentage of patients who develop ≥ grade 2 peripheral neurotoxicity from this regimen.
Estimate the clinical response rate in patients with measurable disease treated with this regimen.
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.

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Procedure: Adjuvant Therapy Drug: Carboplatin Given IV Drug: Paclitaxel Given IV Other Names: Anzatax TAX Biological: Pegfilgrastim Given IV Other Names: Filgrastim SD-01 GCSF-SD01 Neulasta

Arm

Intervention/Treatment

Experimental: 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.

Procedure: Adjuvant Therapy

Drug: Carboplatin

Given IV

Drug: Paclitaxel

Given IV

Other Names:

Anzatax

TAX

Biological: Pegfilgrastim

Given IV

Other Names:

Filgrastim SD-01

GCSF-SD01

Neulasta

Outcome Measures

Primary Outcome Measures

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

Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale [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]
Grade of toxicity as assessed by CTCAE v3.0 [Up to 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Medical Center At Irvine-Orange Campus	Orange	California	United States	92868
2	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
3	Cooper Hospital University Medical Center	Camden	New Jersey	United States	08103
4	New York University Langone Medical Center	New York	New York	United States	10016
5	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio	United States	43210
6	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
7	Lake University Ireland Cancer Center	Mentor	Ohio	United States	44060
8	Cancer Care Associates-Midtown	Tulsa	Oklahoma	United States	74104
9	Women and Infants Hospital	Providence	Rhode Island	United States	02905
10	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington	United States	98109
11	University of Washington Medical Center	Seattle	Washington	United States	98195