New York, New York 10021

  • Cervical Cancer


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.

Study summary:

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.


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



Primary Contact:

Study Chair
Carol Aghajanian, MD
Memorial Sloan-Kettering Cancer Center

Backup Contact:


Location Contact:

New York, New York 10021
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source:

Date Processed: June 17, 2021

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