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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00016926
First received: June 6, 2001
Last updated: May 24, 2013
Last verified: May 2004
  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 advanced, persistent, or recurrent cervical cancer.


Condition Intervention Phase
Cervical Cancer
Drug: capecitabine
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Limited Access Phase II Trial Of Capecitabine In Advanced, Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Study Start Date: April 2001
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016926

Locations
United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
United States, Iowa
Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242-1009
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1065
United States, Tennessee
Brookview Research, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
Norway
Norwegian Radium Hospital
Oslo, Norway, N-0310
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Agustin Garcia, MD University of Southern California
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00016926     History of Changes
Other Study ID Numbers: CDR0000068633, GOG-0076CC
Study First Received: June 6, 2001
Last Updated: May 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
stage III cervical cancer
recurrent cervical cancer
stage IVB cervical cancer
stage IVA cervical cancer
cervical squamous cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Carcinoma
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Capecitabine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014