Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

New York, New York 10021


Purpose:

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.


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


NCT ID:

NCT00005999


Primary Contact:

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


Backup Contact:

N/A


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: ClinicalTrials.gov

Date Processed: September 24, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.