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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed cervical cancer or other pelvic malignancy, including vaginal, endometrial, or ovarian cancer

• Primary or recurrent disease

• Locally advanced disease, defined as the following:

• Stage IB2-IVA (for cervical or vaginal cancer)

• Any non-extra pelvic metastatic stage (for endometrial or ovarian cancer)

• Not amenable to curative surgical resection alone

• Bidimensionally measurable or clinically evaluable disease

• Refused or ineligible for weekly IV cisplatin chemotherapy due to renal insufficiency, prior platinum adverse sensitivity, pre-existing neuropathy, or concurrent co-morbid illness

• 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