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Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

Primary Purpose

Cervical Cancer

Status
Completed
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 Cervical Cancer focused on measuring stage III cervical cancer, recurrent cervical cancer, stage IVB cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed advanced, persistent, or recurrent squamous cell carcinoma of the cervix Documented disease progression after local therapy and considered incurable At least 1 target lesion measurable in at least 1 dimension At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan Target lesion cannot be in a previously irradiated field 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 100,000/mm^3 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 active infection requiring antibiotics No other invasive malignancy within the past 5 years except nonmelanoma skin cancer No neuropathy (sensory and motor) greater than grade I PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy or immunotherapy for the malignant tumor No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: At least 3 weeks since prior chemotherapy for the malignant tumor and recovered No prior cytotoxic therapy (except when used as a radiosensitizer) No prior chemotherapy for other malignancy Endocrine therapy: At least 1 week since prior hormonal therapy for the malignant tumor Concurrent hormone replacement therapy allowed Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy for the malignant tumor and recovered No prior radiotherapy for other malignancy Surgery: Recovered from prior surgery Other: At least 3 weeks since any other prior therapy for the malignant tumor No prior anticancer therapy that contraindicates study therapy No concurrent amifostine or other protective reagents

Sites / Locations

  • Chao Family Comprehensive Cancer Center
  • Indiana University Cancer Center
  • Holden Comprehensive Cancer Center
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
  • University of Mississippi Medical Center
  • Keesler Medical Center - Keesler AFB
  • Comprehensive Cancer Center at Wake Forest University
  • Brookview Research, Inc.
  • University of Texas Medical Branch
  • Norwegian Radium Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
May 24, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00016926
Brief Title
Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
Official Title
A Limited Access Phase II Trial Of Capecitabine In Advanced, Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix
Study Type
Interventional

2. Study Status

Record Verification Date
May 2004
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
July 2007 (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 advanced, persistent, or recurrent cervical cancer.
Detailed Description
OBJECTIVES: Determine the activity of capecitabine in patients with advanced, persistent, or recurrent squamous cell carcinoma of the cervix. Determine the toxicity profile of this drug in this patient population. OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 28-62 patients will be accrued for this study within 9-20 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
stage III cervical cancer, recurrent cervical cancer, stage IVB cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma

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 confirmed advanced, persistent, or recurrent squamous cell carcinoma of the cervix Documented disease progression after local therapy and considered incurable At least 1 target lesion measurable in at least 1 dimension At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR at least 10 mm by spiral CT scan Target lesion cannot be in a previously irradiated field 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 100,000/mm^3 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 active infection requiring antibiotics No other invasive malignancy within the past 5 years except nonmelanoma skin cancer No neuropathy (sensory and motor) greater than grade I PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy or immunotherapy for the malignant tumor No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: At least 3 weeks since prior chemotherapy for the malignant tumor and recovered No prior cytotoxic therapy (except when used as a radiosensitizer) No prior chemotherapy for other malignancy Endocrine therapy: At least 1 week since prior hormonal therapy for the malignant tumor Concurrent hormone replacement therapy allowed Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy for the malignant tumor and recovered No prior radiotherapy for other malignancy Surgery: Recovered from prior surgery Other: At least 3 weeks since any other prior therapy for the malignant tumor No prior anticancer therapy that contraindicates 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
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
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
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1009
Country
United States
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Keesler Medical Center - Keesler AFB
City
Keesler AFB
State/Province
Mississippi
ZIP/Postal Code
39534-2576
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1065
Country
United States
Facility Name
Brookview Research, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0587
Country
United States
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
17049588
Citation
Garcia AA, Blessing JA, Darcy KM, Lenz HJ, Zhang W, Hannigan E, Moore DH. Phase II clinical trial of capecitabine in the treatment of advanced, persistent or recurrent squamous cell carcinoma of the cervix with translational research: a gynecologic oncology group study. Gynecol Oncol. 2007 Mar;104(3):572-9. doi: 10.1016/j.ygyno.2006.09.002. Epub 2006 Oct 17.
Results Reference
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Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer

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