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

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

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynecologic Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine

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