Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

98-112


NCT ID:

NCT00004012


Secondary ID:

CDR0000067229


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Memorial Sloan-Kettering Cancer Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Paul Sabbatini, MD
Study Chair
Memorial Sloan-Kettering Cancer Center

Study Dates

Start Date:December 1998
Completion Date:December 2000
Completion Type:Actual
Primary Completion Date:December 2000
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 20, 2013
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:capecitabine

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Memorial Sloan-Kettering Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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