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Docetaxel in Treating Women With Ovarian Epithelial or Primary Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT00004081
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 13, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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:

OBJECTIVES:

  • 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 Design

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


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Performance status:

  • ECOG 0-2

Life expectancy:

  • Greater than 2 months

Hematopoietic:

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

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • Acceptable cardiac exam
  • No active cardiac ischemia

Pulmonary:

  • Acceptable pulmonary exam
  • No active pulmonary infection or compromise

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior cytokine therapy

Chemotherapy:

  • 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

Radiotherapy:

  • No prior pelvic radiotherapy

Surgery:

  • Not specified
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00004081


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

Publications:
Responsible Party: Stephen Cannistra, MD, Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00004081     History of Changes
Other Study ID Numbers: CDR0000067292
BIH-99-1286
NCI-V99-1565
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
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action