COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00352300
Recruitment Status : Completed
First Posted : July 14, 2006
Last Update Posted : December 31, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

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:


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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
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 : June 2006
Actual Primary Completion Date : July 2010

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Number of patients with > grade 1 peripheral neuropathy based on the GOG neurotoxicity scale [ Time Frame: Up to 1 year ]
  2. 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 ]
  3. Grade of toxicity as assessed by CTCAE v3.0 [ Time Frame: Up to 1 year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00352300

Layout table for location information
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)
Layout table for investigator information
Principal Investigator: Amy Tiersten Gynecologic Oncology Group

Layout table for additonal information
Responsible Party: Gynecologic Oncology Group Identifier: NCT00352300    
Other Study ID Numbers: GOG-9919
NCI-2009-00622 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
GOG-9919 ( Other Identifier: Gynecologic Oncology Group )
GOG-9919 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: July 14, 2006    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Mixed Tumor, Mullerian
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Leukocyte Disorders
Hematologic Diseases
Neoplasms, Complex and Mixed
Neoplasms, Connective and Soft Tissue
Albumin-Bound Paclitaxel