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

Gynecologic Oncology Group (GOG)

Status and phase: Completed; Phase 2

Conditions: Cervical Cancer

Treatments: Drug: capecitabine

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00016926

CDR0000068633

GOG-0076CC

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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