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

This study has been suspended.

Sponsors and Collaborators: Gynecologic Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
stage III cervical cancer
recurrent cervical cancer
stage IVB cervical cancer
stage IVA cervical cancer
cervical squamous cell carcinoma
 Drug: capecitabine
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Cervical Cancer;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Capecitabine in Patients With Advanced, Persistent, or Recurrent Squamous Cell Carcinoma of the Cervix

Further Study Details: 

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:  Both

Criteria

DISEASE CHARACTERISTICS:

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:

Chemotherapy:

Endocrine therapy:

Radiotherapy:

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

Location Information


California
      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States

Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States

Iowa
      Holden Comprehensive Cancer Center, Iowa City,  Iowa,  52242-1009,  United States

Maryland
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States

Mississippi
      Keesler Medical Center - Keesler AFB, Keesler AFB,  Mississippi,  39534-2576,  United States

      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States

North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1065,  United States

Tennessee
      Brookview Research, Inc., Nashville,  Tennessee,  37203,  United States

Texas
      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States

Norway
      Norwegian Radium Hospital, Oslo,  N-0310,  Norway

Study chairs or principal investigators

Agustin Garcia, MD,  Study Chair,  University of Southern California   

More Information

Study ID Numbers:  CDR0000068633; GOG-0076CC
Record last reviewed:  June 2003
Last Updated:  October 13, 2004
Record first received:  June 6, 2001
ClinicalTrials.gov Identifier:  NCT00016926
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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