Original Query: ALL
Previous Study | Return to List | Next Study

Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal 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: NCT00004081
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 13, 2012
Information provided by (Responsible Party):
Stephen Cannistra, MD, Beth Israel Deaconess Medical Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating women who have ovarian epithelial cancer or primary peritoneal cancer that has not responded to previous treatment.

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

Detailed Description:


  • Determine the activity of docetaxel in women with platinum resistant, refractory ovarian epithelial or primary peritoneal serous cancer.

OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive a minimum of 6 courses of therapy, including 2 courses beyond CR.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Weekly, Low-Dose Docetaxel (Taxotere) in Patients With Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Serous Cancer
Study Start Date : July 1999
Primary Completion Date : January 2002
Study Completion Date : March 2003

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.

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


  • Histologically confirmed ovarian epithelial or primary peritoneal serous cancer that is resistant to platinum therapy
  • Platinum resistance as defined by one of the following:

    • Relapse within 6 months of platinum based chemotherapy
    • Residual disease after completion of platinum based chemotherapy
    • Disease progression while receiving platinum based chemotherapy
    • Marker only relapse (CA-125 elevation) and measurable disease
  • Bidimensionally measurable disease on exam or CT scan



  • 18 and over


  • Female

Performance status:

  • ECOG 0-2

Life expectancy:

  • Greater than 2 months


  • WBC at least 3,000/mm3
  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3


  • Bilirubin no greater than upper limit of normal (ULN)
  • SGPT or SGOT no greater than 1.5 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN


  • Creatinine no greater than 1.5 mg/dL


  • Acceptable cardiac exam
  • No active cardiac ischemia


  • Acceptable pulmonary exam
  • No active pulmonary infection or compromise


  • Not pregnant or nursing
  • No severe peripheral neuropathy (grade 2 or greater)
  • No other significant psychiatric or medical conditions that would interfere with compliance
  • No other malignancies within the past 3 years, except:

    • Limited basal or squamous cell skin cancer
    • Carcinoma in situ of the cervix


Biologic therapy:

  • No prior cytokine therapy


  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy for ovarian epithelial or peritoneal serous cancer
  • Prior paclitaxel allowed
  • No prior docetaxel
  • At least 3 years since prior chemotherapy for other disease

Endocrine therapy:

  • Not specified


  • No prior pelvic radiotherapy


  • Not specified

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): NCT00004081

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Study Chair: Stephen A. Cannistra, MD Beth Israel Deaconess Medical Center

Publications of Results:
Responsible Party: Stephen Cannistra, MD, Investigator, Beth Israel Deaconess Medical Center Identifier: NCT00004081     History of Changes
Other Study ID Numbers: CDR0000067292
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 13, 2012
Last Verified: August 2012

Keywords provided by Stephen Cannistra, MD, Beth Israel Deaconess Medical Center:
recurrent ovarian epithelial cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Peritoneal Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action