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

NCT ID: NCT00016926

Last Updated: 2013-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30

Brief 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.

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.

Conditions

Cervical Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

capecitabine

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Principal Investigators

Agustin Garcia, MD

Role: STUDY_CHAIR

University of Southern California

Locations

Chao Family Comprehensive Cancer Center

Orange, California, United States

Indiana University Cancer Center

Indianapolis, Indiana, United States

Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Keesler Medical Center - Keesler AFB

Keesler Air Force Base, Mississippi, United States

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, United States

Brookview Research, Inc.

Nashville, Tennessee, United States

University of Texas Medical Branch

Galveston, Texas, United States

Norwegian Radium Hospital

Oslo, , Norway

Countries

United States; Norway

References

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):572-9. doi: 10.1016/j.ygyno.2006.09.002. Epub 2006 Oct 17.

Reference Type: RESULT

PMID: 17049588 (View on PubMed)

Other Identifiers

GOG-0076CC

Identifier Type: -

Identifier Source: secondary_id

CDR0000068633

Identifier Type: -

Identifier Source: org_study_id