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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00061958 |
Purpose
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.
Eligibility| 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
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000302483, MDA-DM-02172, NCI-5647 |
| Study First Received: | June 5, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00061958 History of Changes |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the esophagus stage III esophageal cancer stage IV esophageal cancer |
|
Digestive System Neoplasms Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Arsenic trioxide Pharmacologic Actions Neoplasms |
Digestive System Diseases Neoplasms by Site Head and Neck Neoplasms Therapeutic Uses Gastrointestinal Neoplasms Esophageal Diseases |