Know Cancer

forgot password

A Phase II Trial of Paclitaxel Administered Weekly in Patients With Advanced Ovarian Cancer

Phase 2
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

A Phase II Trial of Paclitaxel Administered Weekly in Patients With Advanced Ovarian Cancer

OBJECTIVES: I. Evaluate the activity of paclitaxel when administered on a weekly schedule to
patients with advanced ovarian cancer who have failed paclitaxel on a 3 or 24 hour infusion
schedule. II. Evaluate the toxic effects of paclitaxel when administered on a weekly
schedule in this patient population. III. Correlate response with quality of life outcomes,
including symptom distress, performance status, and global quality of life.

OUTLINE: This is a single center, open label study. Paclitaxel is administered intravenously
every week as a 1 hour infusion. Patients receive prophylactic anti-allergy premedication
prior to paclitaxel.

PROJECTED ACCRUAL: 25-30 patients accrued per year.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or progressive epithelial
ovarian cancer defined as: A serial rise in CA 125 over a minimum of 3 samples to a level
greater than 50% of the upper limit of normal OR Measurable or evaluable disease Disease
progression following paclitaxel given by 3 or 24 hour infusion within the past 6 months

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky at least 60% Life
expectancy: Not specified Hematopoietic: AGC at least 1500/uL Platelet count at least
100,000/uL Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than
2.0 mg/dL Other: No active or uncontrolled infections No history of grade 3-4 peripheral
neuropathy of any etiology No previously developed severe hypersensitivity reactions to
paclitaxel Not pregnant or lactating Patients of childbearing potential must use effective
method of contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior platinum
based chemotherapy required Complete recovery from the myelosuppressive effects of prior
chemotherapy for a minimum of 3 weeks At least one prior regimen of paclitaxel by 3 or 24
hour infusion within 6 months prior to study, with no intervening chemotherapy Endocrine
therapy: No hormone therapy within 3 weeks of entry onto protocol Radiotherapy: No prior
radiation therapy to major bone marrow ares within 4 weeks of entry onto protocol Surgery:
Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Carol Aghajanian, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 1997

Completion Date:

August 2001

Related Keywords:

  • Ovarian Cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021