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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00016926
• Other study ID #: CDR0000068633
• Secondary ID: GOG-0076CC
• Status: Completed
• Phase: Phase 2
• First received: June 6, 2001
• Last updated: May 24, 2013
• Start date: April 2001

Study information

• Verified date: May 2004
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• capecitabine

Locations

Country	Name	City	State
Norway	Norwegian Radium Hospital	Oslo
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland
United States	University of Texas Medical Branch	Galveston	Texas
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Keesler Medical Center - Keesler AFB	Keesler AFB	Mississippi
United States	Brookview Research, Inc.	Nashville	Tennessee
United States	Chao Family Comprehensive Cancer Center	Orange	California
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Norway, 

References & Publications (1)

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 oncolo — View Citation