Capecitabine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004012

Enrollment

Unknown

Registered

2004-05-25

Start date

1998-12-31

Completion date

2000-12-31

Last updated

2013-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer

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 capecitabine in treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.

Detailed description

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.

Interventions

DRUGcapecitabine

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026