This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer

This study has been completed.
Information provided by (Responsible Party):
Stephen Cannistra, MD, Beth Israel Deaconess Medical Center Identifier:
First received: December 10, 1999
Last updated: August 9, 2012
Last verified: August 2012

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 Intervention Phase
Ovarian Cancer Peritoneal Cavity Cancer Drug: docetaxel Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Stephen Cannistra, MD, Beth Israel Deaconess Medical Center:

Enrollment: 30
Study Start Date: July 1999
Study Completion Date: March 2003
Primary Completion Date: January 2002 (Final data collection date for primary outcome measure)
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.


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
  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: 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
  More Information

Responsible Party: Stephen Cannistra, MD, Investigator, Beth Israel Deaconess Medical Center Identifier: NCT00004081     History of Changes
Other Study ID Numbers: CDR0000067292
Study First Received: December 10, 1999
Last Updated: August 9, 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 processed this record on September 21, 2017