Capecitabine in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer

Ovarian Cancer Clinical Trial

Official title:

Phase II Evaluation Of Capecitabine In Recurrent Platinum-Sensitive Ovarian Or Primary Peritoneal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00006812
• Other study ID #: CDR0000068330
• Secondary ID: GOG-0146L
• Status: Terminated
• Phase: Phase 2
• First received: December 6, 2000
• Last updated: April 10, 2013
• Start date: March 2001

Study information

• Verified date: November 2005
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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 epithelial or primary peritoneal cavity cancer.

Description:

OBJECTIVES:

• Determine the antitumor activity of capecitabine in patients with recurrent, platinum-sensitive ovarian epithelial or primary peritoneal cavity cancer.

• Determine the nature and degree of toxicity of this drug in this patient population.

OUTLINE: This is a multicenter study.

Patients receive oral capecitabine twice daily for 14 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 6-12 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically proven recurrent ovarian epithelial or primary peritoneal cavity cancer

• Measurable disease

• At least 1 unidimensionally measurable lesion

• Ascites and pleural effusions are not considered measurable disease

• Prior therapy must include 1 platinum-based chemotherapy regimen for primary disease containing carboplatin, cisplatin, or another organoplatinum compound

• Treatment-free interval of 6-12 months after response to platinum therapy

• Not eligible for higher priority GOG protocol

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• GOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least lower limit of normal

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• SGOT no greater than 2.5 times ULN

• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine clearance at least 50 mL/min

Other:

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

• No neuropathy (sensory and motor) greater than grade 1

• No other malignancy within the past 5 years except nonmelanoma skin cancer

• No concurrent active infection requiring antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior biologic or immunologic therapy

• No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy:

• See Disease Characteristics

• If no prior therapy with paclitaxel, a second regimen including paclitaxel allowed

• No prior capecitabine or fluorouracil

• No prior chemotherapy for recurrent or persistent disease, including pretreatment with initial chemotherapy regimens

• Recovered from prior chemotherapy

Endocrine therapy:

• At least 1 week since prior hormonal therapy directed at malignant tumor

• Concurrent continuation of hormone replacement therapy allowed

Radiotherapy:

• At least 3 weeks since prior radiotherapy and recovered

• No prior radiotherapy to site(s) of measurable disease

• No prior radiotherapy to more than 25% of bone marrow

Surgery:

• Recovered from prior surgery

Other:

• No prior cancer treatment that would preclude study therapy

• No concurrent amifostine or other protective reagents

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• capecitabine

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Radiation Oncology Branch	Bethesda	Maryland
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Tufts University School of Medicine	Boston	Massachusetts
United States	State University of New York Health Science Center at Brooklyn	Brooklyn	New York
United States	Cooper Hospital/University Medical Center	Camden	New Jersey
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Rush-Presbyterian-St. Luke's Medical Center	Chicago	Illinois
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center at The University of Iowa	Iowa City	Iowa
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	University of Oklahoma College of Medicine	Oklahoma City	Oklahoma
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	State University of New York Health Sciences Center - Stony Brook	Stony Brook	New York
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Garcia AA, Blessing JA, Lenz HJ, Darcy KM, Mannel RS, Miller DS, Husseinzadeh N; Gynecologic Oncology Group. Phase II clinical trial of capecitabine in ovarian carcinoma recurrent 6-12 months after completion of primary chemotherapy, with exploratory TS, — View Citation