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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005999 |
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.
Condition | Intervention | Phase |
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Cervical Cancer |
Drug: arsenic trioxide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study of Arsenic Trioxide (NSC #706363) in Patients With Advanced Cervical Carcinoma |
Study Start Date: | April 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 17 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage IVB or recurrent cervical carcinoma that is not amenable to standard curative therapies
Measurable disease
Nonmeasurable disease defined as any of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Carol Aghajanian, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000068003, MSKCC-00018, NCI-30 |
Study First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005999 History of Changes |
Health Authority: | United States: Federal Government |
recurrent cervical cancer stage IVB cervical cancer cervical squamous cell carcinoma cervical adenocarcinoma |
Epidermoid Carcinoma Arsenic trioxide Squamous Cell Carcinoma Adenocarcinoma |
Carcinoma, Squamous Cell Recurrence Carcinoma |
Antineoplastic Agents Therapeutic Uses Arsenic trioxide Pharmacologic Actions |