Arsenic Trioxide in Treating Patients With Stage IVB or Recurrent Cervical Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Arsenic Trioxide (NSC #706363) in Patients With Advanced Cervical Carcinoma

Conditions
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Cervical Cancer

Intervention / Treatment
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* Drug: arsenic trioxide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: arsenic trioxide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent cervical cancer, stage IVB cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma