Capecitabine and Radiation Therapy in Treating Patients With Locally Advanced Cervical Cancer or Other Pelvic Cancer

NCT ID: NCT00118300

Last Updated: 2011-07-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with radiation therapy in treating patients with locally advanced cervical cancer or other pelvic cancer.

Detailed Description

OBJECTIVES:

Primary

• Determine the maximum tolerated dose and dose-limiting toxicity of capecitabine when given in combination with pelvic external beam radiotherapy and intracavitary brachytherapy in patients with primary or recurrent locally advanced cervical cancer or other pelvic malignancy.

Secondary

• Determine the clinical anti-tumor response in patients treated with this regimen.
• Determine adverse clinical sequelae in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of capecitabine.

Patients undergo external beam radiotherapy to the whole pelvis once daily 5 days a week in weeks 1-5 and receive 1 or 2 applications of low-dose rate intracavitary brachytherapy in weeks 7-8 OR 5 applications of high-dose rate (HDR)* intracavitary brachytherapy once weekly in weeks 4-8. Patients also receive oral capecitabine twice daily 7 days a week in weeks 1-5 and 7-8. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

NOTE: *No external beam radiotherapy is administered on the day of HDR brachytherapy. If the majority of external beam radiotherapy has been administered, HDR brachytherapy may be administered in 2 applications per week (separated by at least 72 hours) in order to complete all treatment by week 8.

Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A minimum of 6 patients are treated at the MTD.

After completion of study treatment, patients are followed at 1 month, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.

PROJECTED ACCRUAL: Approximately 4-24 patients will be accrued for this study within 2-12 months.

Conditions

Cervical Cancer; Endometrial Cancer; Ovarian Cancer; Vaginal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

capecitabine

Patients also receive oral capecitabine twice daily 7 days a week in weeks 1-5 and 7-8. Courses repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.

Intervention Type: DRUG

brachytherapy

1 or 2 applications of low-dose rate intracavitary brachytherapy in weeks 7-8 OR 5 applications of high-dose rate (HDR)\* intracavitary brachytherapy once weekly in weeks 4-8.

Intervention Type: RADIATION

radiation therapy

Patients undergo external beam radiotherapy to the whole pelvis once daily 5 days a week in weeks 1-5.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• No histologically confirmed or clinically suspicious (≥ 1 cm) para-aortic lymphadenopathy
• No brain metastases or primary brain tumors

PATIENT CHARACTERISTICS:

Age

• 18 and over (80 and under for second and third dose-escalation levels)

Performance status

• GOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Absolute granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 10.0 g/dL

Hepatic

• Bilirubin ≤ 1.5 mg/dL
• AST and ALT < 2 times upper limit of normal

Renal

• See Disease Characteristics
• Creatinine normal OR
• Creatinine clearance ≥ 30 mL/min*
• No proteinuria or clinically significant impaired renal function NOTE: *Creatine clearance testing required in patients > 60 years of age

Cardiovascular

• No symptomatic New York Heart Association class III or IV congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia
• No uncontrolled hypertension

Gastrointestinal

• Able to swallow oral medication
• No bowel obstruction
• No malabsorption illness

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No known hypersensitivity to capecitabine or fluorouracil
• No ongoing or active infection
• No other uncontrolled illness
• No psychiatric illness or social situation that would preclude study compliance
• No other active invasive malignancy

• Prior malignancy in remission for ≥ 6 months that is not currently being treated allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Recovered from prior chemotherapy
• At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
• Prior chemotherapy for a non-gynecologic malignancy or in the adjuvant setting allowed
• No prior capecitabine

Endocrine therapy

• Prior adjuvant hormonal therapy allowed

Radiotherapy

• Recovered from prior radiotherapy
• At least 4 weeks since prior radiotherapy
• Prior radiotherapy for a non-gynecologic malignancy allowed
• No prior low abdominal or pelvic radiotherapy

Surgery

• Not specified

Other

• At least 3 weeks since prior investigational anticancer agents and recovered
• No prior anticancer treatment that contraindicates study therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Principal Investigators

Charles Kunos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Locations

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Related Links

http://clinicaltrials.gov/ct2/results?term=case9804

Clinical trial summary from the National Cancer Institute's PDQ® database

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE-9804

Identifier Type: OTHER

Identifier Source: secondary_id

CWRU-010514

Identifier Type: -

Identifier Source: secondary_id

CASE9804

Identifier Type: -

Identifier Source: org_study_id