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

Gynecologic Oncology Group (GOG)

Status and phase

Completed

Phase 1

Conditions

Stage III Ovarian Cancer

Neutropenia

Primary Peritoneal Carcinoma

Ovarian Carcinosarcoma

Infectious Disorder

Stage IV Ovarian Cancer

Fallopian Tube Carcinoma

Treatments

Procedure: Adjuvant Therapy

Drug: Carboplatin

Drug: Paclitaxel

Biological: Pegfilgrastim

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00352300

U10CA027469 (U.S. NIH Grant/Contract)

CDR0000486412

NCI-2009-00622 (Registry Identifier)

GOG-9919

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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