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A Limited Access Phase II Trial Of Capecitabine In Advanced, Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix


Phase 2
N/A
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

A Limited Access Phase II Trial Of Capecitabine In Advanced, Persistent Or Recurrent Squamous Cell Carcinoma Of The Cervix


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Agustin Garcia, MD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068633

NCT ID:

NCT00016926

Start Date:

April 2001

Completion Date:

Related Keywords:

  • Cervical Cancer
  • stage III cervical cancer
  • recurrent cervical cancer
  • stage IVB cervical cancer
  • stage IVA cervical cancer
  • cervical squamous cell carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms

Name

Location

Chao Family Comprehensive Cancer CenterOrange, California  92868
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Brookview Research, Inc.Nashville, Tennessee  37203
University of Texas Medical BranchGalveston, Texas  77555-1329
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182