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A Phase II Trial of Weekly, Low-Dose Docetaxel (Taxotere) in Patients With Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Serous Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

A Phase II Trial of Weekly, Low-Dose Docetaxel (Taxotere) in Patients With Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Serous Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Stephen A. Cannistra, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000067292

NCT ID:

NCT00004081

Start Date:

July 1999

Completion Date:

March 2003

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215