Cervical Cancer
Conditions
Keywords
recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma
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 arsenic trioxide in treating patients who have stage IVB or recurrent cervical cancer.
Detailed description
OBJECTIVES: * Evaluate the efficacy of arsenic trioxide in patients with stage IVB or recurrent cervical carcinoma. * Determine the safety of this treatment in these patients. OUTLINE: Patients receive arsenic trioxide IV over 1-4 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 10-19 months.
Interventions
DRUGarsenic trioxide
Sponsors
National Cancer Institute (NCI)
Memorial Sloan Kettering Cancer Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed stage IVB or recurrent cervical carcinoma that is not amenable to standard curative therapies * Squamous carcinoma OR * Adenocarcinoma * Measurable disease * At least 20 mm by conventional techniques OR * At least 10 mm by spiral CT scan * Nonmeasurable disease defined as any of the following: * Bone disease * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Inflammatory breast disease * Lymphangitis cutis/pulmonis * Abdominal masses not confirmed or followed by imaging techniques * Cystic lesions * No active brain metastases PATIENT CHARACTERISTICS: Age: * 17 and over Performance status: * Karnofsky 60-100% Life expectancy: * Greater than 3 months 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) * AST and ALT no greater than 2.5 times ULN Renal: * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 50 mL/min Cardiovascular: * No cardiac arrhythmias, unstable angina, or conduction abnormalities * No New York Heart Association class III or IV heart disease or clinical evidence of congestive heart failure * Pretreatment QTc less than 500 msec Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 4 months after study * No grade 3 or greater neurologic abnormalities * No history of seizures * No concurrent uncontrolled active infection PRIOR CONCURRENT THERAPY: Biologic therapy: * No more than 2 prior therapies for advanced disease Chemotherapy: * No more than 2 prior therapies for advanced disease * At least 4 weeks since prior chemotherapy Endocrine therapy: * No more than 2 prior therapies for advanced disease Radiotherapy: * No more than 2 prior therapies for advanced disease * At least 4 weeks since prior radiotherapy Surgery: * Not specified Other: * At least 4 weeks since prior cytotoxic therapy or investigational agents
Countries
United States
Outcome results
None listed