Full Text View
Tabular View
No Study Results Posted
Related Studies
Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
This study has been completed.
Study NCT00016926   Information provided by National Cancer Institute (NCI)
First Received: June 6, 2001   Last Updated: July 23, 2008   History of Changes

June 6, 2001
July 23, 2008
April 2001
July 2007   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00016926 on ClinicalTrials.gov Archive Site
 
 
 
Capecitabine in Treating Patients With Advanced, Persistent, or Recurrent Cervical Cancer
A Limited Access Phase II Trial Of Capecitabine In Advanced, Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix

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.

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.

Phase II
Interventional
Treatment
Cervical Cancer
Drug: capecitabine
 
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):572-579. Epub 2006 Oct 17.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
July 2007   (final data collection date for primary outcome measure)

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
Female
 
No
Contact information is only displayed when the study is recruiting subjects
United States,   Norway
 
NCT00016926
 
CDR0000068633, GOG-0076CC
Gynecologic Oncology Group
National Cancer Institute (NCI)
Study Chair: Agustin Garcia, MD USC/Norris Comprehensive Cancer Center
National Cancer Institute (NCI)
May 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP