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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group Identifier:
First received: July 13, 2006
Last updated: December 29, 2014
Last verified: December 2014

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Gynecologic Oncology Group:

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) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
  • Frequency and duration of objective response (complete and partial response) assessed by Response Evaluation Criteria for Solid Tumors (RECIST) [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Grade of toxicity as assessed by CTCAE v3.0 [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 43
Study Start Date: June 2006
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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

Detailed Description:


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.


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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00352300

United States, California
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States, 92868
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
United States, New York
New York University Langone Medical Center
New York, New York, United States, 10016
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
Cancer Care Associates-Midtown
Tulsa, Oklahoma, United States, 74104
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Amy Tiersten Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group Identifier: NCT00352300     History of Changes
Other Study ID Numbers: GOG-9919, NCI-2009-00622, CDR0000486412, GOG-9919, GOG-9919, GOG-9919, U10CA027469
Study First Received: July 13, 2006
Last Updated: December 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Communicable Diseases
Fallopian Tube Neoplasms
Mixed Tumor, Mullerian
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Hematologic Diseases
Leukocyte Disorders
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Connective and Soft Tissue
Neoplasms, Glandular and Epithelial
Ovarian Diseases
Urogenital Neoplasms
Paclitaxel processed this record on October 09, 2015