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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 5, 2003 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | June 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00061958 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Arsenic Trioxide in Treating Patients With Advanced Cancer of the Esophagus or Gastroesophageal Junction | ||||
| Official Title ICMJE | A Phase II Study of Arsenic Trioxide (NSC 706363) in Patients With Advanced Adenocarcinoma of the Esophagus or Gastroesophageal Junction | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Esophageal Cancer | ||||
| Intervention ICMJE | Drug: arsenic trioxide | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00061958 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000302483, MDA-DM-02172, NCI-5647 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | July 2004 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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