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A Phase II Trial of Oral Capecitabine in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma


Phase 2
N/A
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Trial of Oral Capecitabine in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma


OBJECTIVES: I. Determine the response rate and time to treatment failure in patients with
recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with
oral capecitabine. II. Determine the tolerability and safety of this regimen in these
patients.

OUTLINE: Patients receive oral capecitabine twice daily for 14 days. Treatment continues
every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 14-35 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed recurrent ovarian epithelial carcinoma,
fallopian tube cancer, or primary peritoneal cancer previously treated with at least one
cisplatin based chemotherapy regimen Prior repeat treatment with a taxane and/or platinum
agent allowed Prior repeat treatment with other chemotherapy agent allowed once Recurrent
disease defined as: At least one site of measurable disease by radiograph and/or a rise of
CA-125 over a minimum of 3 samples to a level of at least 50% of upper limit of normal

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 times upper limit of
normal (ULN) SGOT less than 2.0 times ULN Alkaline phosphatase less than 2.0 times ULN
Renal: Creatinine no greater than 1.5 mg/dL Other: Must be able to take oral medication

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No prior fluorouracil based chemotherapy Endocrine therapy: Not specified
Radiotherapy: Not specified Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Paul Sabbatini, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

98-112

NCT ID:

NCT00004012

Start Date:

December 1998

Completion Date:

December 2000

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

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