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

Primary Purpose

Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
capecitabine
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian epithelial cancer, primary peritoneal cavity cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Jonsson Comprehensive Cancer Center, UCLA
  • Chao Family Comprehensive Cancer Center
  • University of Colorado Cancer Center
  • H. Lee Moffitt Cancer Center and Research Institute
  • Rush-Presbyterian-St. Luke's Medical Center
  • Indiana University Cancer Center
  • Holden Comprehensive Cancer Center at The University of Iowa
  • Radiation Oncology Branch
  • Tufts University School of Medicine
  • University of Massachusetts Memorial Medical Center
  • University of Minnesota Cancer Center
  • Mayo Clinic Cancer Center
  • Ellis Fischel Cancer Center - Columbia
  • Washington University School of Medicine
  • Cooper Hospital/University Medical Center
  • State University of New York Health Science Center at Brooklyn
  • Memorial Sloan-Kettering Cancer Center
  • State University of New York Health Sciences Center - Stony Brook
  • Lineberger Comprehensive Cancer Center, UNC
  • Duke Comprehensive Cancer Center
  • Comprehensive Cancer Center at Wake Forest University
  • Cleveland Clinic Taussig Cancer Center
  • Arthur G. James Cancer Hospital - Ohio State University
  • University of Oklahoma College of Medicine
  • Abington Memorial Hospital
  • Milton S. Hershey Medical Center
  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
  • University of Texas - MD Anderson Cancer Center
  • Tom Baker Cancer Center - Calgary

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 6, 2000
Last Updated
April 10, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006812
Brief Title
Capecitabine in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cavity Cancer
Official Title
Phase II Evaluation Of Capecitabine In Recurrent Platinum-Sensitive Ovarian Or Primary Peritoneal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Terminated
Study Start Date
March 2001 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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 epithelial or primary peritoneal cavity cancer.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, primary peritoneal cavity cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
capecitabine

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agustin Garcia, MD
Organizational Affiliation
University of Southern California
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Rush-Presbyterian-St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Holden Comprehensive Cancer Center at The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Radiation Oncology Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
Tufts University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Ellis Fischel Cancer Center - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Cooper Hospital/University Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
State University of New York Health Science Center at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
State University of New York Health Sciences Center - Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790-7775
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
University of Oklahoma College of Medicine
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Tom Baker Cancer Center - Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15721430
Citation
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, DPD, and TP correlates: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Mar;96(3):810-7. doi: 10.1016/j.ygyno.2004.11.037.
Results Reference
result

Learn more about this trial

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

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