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Docetaxel and Carboplatin in Treating Patients With Relapsed Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cavity 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: NCT00217568
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 21, 2010
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel together with carboplatin works in treating patients with relapsed stage III or stage IV ovarian epithelial or primary peritoneal cavity cancer.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Peritoneal Cavity Cancer Biological: pegfilgrastim Drug: carboplatin Drug: docetaxel Phase 2

Detailed Description:


  • Determine the toxicity of docetaxel and carboplatin in patients with platinum-sensitive stage III or IV ovarian epithelial or primary peritoneal cavity cancer in first relapse.
  • Determine the response rates (complete and partial response) in patients treated with this regimen.
  • Determine relapse rates and event-free survival and overall survival rates in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive pegfilgrastim subcutaneously on day 2 . Treatment repeats every 21 days for up to 6 courses.

After completion of study treatment, patients are followed at 3 weeks, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 years.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Docetaxel and Carboplatin for First Relapsed Platinum-Sensitive Stage III and IV Advanced Ovarian Cancer or Peritoneal Carcinoma
Study Start Date : May 2005
Actual Primary Completion Date : March 2006

Primary Outcome Measures :
  1. Toxicity
  2. Response rates (complete and partial response)
  3. Relapse rates
  4. Event-free survival
  5. Overall survival

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer

    • Stage III or IV disease
    • No borderline tumors
  • Measurable or evaluable disease

    • Measurable disease, defined as evidence of disease by physical examination or radiographic evaluation
    • Evaluable disease, defined as CA 125 ≥ 100 U/mL (confirmed by 2 blood tests performed ≥ 1 week apart)
  • In first relapse

    • Platinum-sensitive disease, defined as initial relapse > 6 months after completion of a platinum-based regimen



  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • Not specified


  • Platelet count ≥ 100,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3


  • Bilirubin normal
  • Meets 1 of the following criteria:

    • SGOT and/or SGPT ≤ 1.5 times upper limit of normal (ULN) AND alkaline phosphatase (AP) ≤ 2.5 times ULN
    • SGOT and/or SGPT ≤ 5.0 times ULN AND AP normal


  • Creatinine ≤ 2.0 mg/dL
  • Creatinine clearance > 50 mL/min


  • LVEF ≥ 50%
  • No poorly controlled arrhythmia
  • No unstable coronary artery disease or myocardial infarction within the past year


  • HIV negative
  • No pre-existing peripheral neuropathy > grade 2
  • No history of allergy to study drugs


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy

  • Not specified


  • At least 3 weeks since prior radiotherapy and recovered


  • Recovered from recent prior surgery


  • No concurrent myelosuppressive therapy

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): NCT00217568

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United States, Washington
Pacific Gynecology Specialists
Seattle, Washington, United States, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
University of Washington School of Medicine
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
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Principal Investigator: Leona A. Holmberg, MD, PhD Fred Hutchinson Cancer Research Center

Layout table for additonal information Identifier: NCT00217568    
Other Study ID Numbers: PSOC 1702
CDR0000441307 ( Registry Identifier: PDQ )
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 21, 2010
Last Verified: September 2010
Keywords provided by Fred Hutchinson Cancer Research Center:
recurrent ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action