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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00061958 |
RATIONALE: Drugs used in chemotherapy such as arsenic trioxide use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating patients with metastatic or unresectable cancer of the esophagus or gastroesophageal junction.
Condition | Intervention | Phase |
---|---|---|
Esophageal Cancer |
Drug: arsenic trioxide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Arsenic Trioxide (NSC 706363) in Patients With Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction |
Study Start Date: | June 2003 |
OBJECTIVES:
OUTLINE: This is an open-label study.
Patients receive a loading dose of arsenic trioxide IV over 2 hours on days 1-5 on week 1. Beginning on week 2, patients receive a maintenance dose of arsenic trioxide IV twice weekly thereafter. Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) continue to receive therapy for at least 6 months beyond CR.
Patients are followed every 3 months for 6 months or until disease progression.
PROJECTED ACCRUAL: A total of 17-50 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No other concurrent active malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Texas | |
MD Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Jaffer A. Ajani, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000302483, MDA-DM-02172, NCI-5647 |
Study First Received: | June 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00061958 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the esophagus stage III esophageal cancer stage IV esophageal cancer |
Digestive System Neoplasms Digestive System Diseases Esophageal disorder Gastrointestinal Diseases Head and Neck Neoplasms Esophageal Neoplasms |
Arsenic trioxide Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Esophageal neoplasm |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |