Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Albert Einstein College of Medicine of Yeshiva University National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004149 |
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 IV prostate cancer that has not responded to hormone therapy.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: arsenic trioxide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of Arsenic Trioxide in Advanced Hormone-Refractory Prostate Cancer |
Study Start Date: | September 1999 |
OBJECTIVES:
OUTLINE: Patients receive arsenic trioxide IV over 2 hours on days 1-5 and 8-12 for one course. Treatment continues as biweekly infusions for at least 14 additional weeks in the absence of disease progression, unacceptable toxicity, or excessive increase in serum prostate-specific antigen.
Pain is assessed at baseline and then before each biweekly treatment.
PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 12-24 months.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of stage IVA or IVB hormone-refractory prostate cancer
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 | |
Albert Einstein Clinical Cancer Center | |
Bronx, New York, United States, 10467 | |
Jacobi Medical Center | |
Bronx, New York, United States, 10461 | |
Mount Sinai Medical Center, NY | |
New York, New York, United States, 10029 |
Study Chair: | Robert E. Gallagher, MD | Albert Einstein College of Medicine of Yeshiva University |
Study ID Numbers: | CDR0000067382, AECM-1199908270, NCI-T99-0077, AECM-CCRC-9929 |
Study First Received: | December 10, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004149 |
Health Authority: | United States: Federal Government |
stage IV prostate cancer recurrent prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Arsenic trioxide Urogenital Neoplasms |
Genital Diseases, Male Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |