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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077545 |
RATIONALE: Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may help cisplatin kill more cancer cells by making them more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction.
Condition | Intervention | Phase |
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Esophageal Cancer |
Drug: cisplatin Drug: triapine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma |
Study Start Date: | January 2004 |
Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive 3-AP (Triapine^®) IV over 2 hours on days 1-4. Patients also receive cisplatin IV over 60 minutes on days 2 and 3 before 3-AP infusion. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for up to 2 years.
PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 20 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Illinois | |
Central Illinois Hematology Oncology Center | |
Springfield, Illinois, United States, 62701 | |
Decatur Memorial Hospital Cancer Care Institute | |
Decatur, Illinois, United States, 62526 |
Study Chair: | Ann M. Mauer, MD | University of Chicago |
Study ID Numbers: | CDR0000352307, UCCRC-12765A, NCI-6285 |
Study First Received: | February 10, 2004 |
Last Updated: | July 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00077545 History of Changes |
Health Authority: | United States: Federal Government |
recurrent esophageal cancer stage IV esophageal cancer adenocarcinoma of the esophagus |
Digestive System Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Esophageal Cancer Recurrence Carcinoma Digestive System Diseases Radiation-Sensitizing Agents |
Cisplatin Esophageal Disorder Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Digestive System Neoplasms Antineoplastic Agents Gastrointestinal Diseases Esophageal Neoplasms Physiological Effects of Drugs Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases |
Neoplasms by Site Radiation-Sensitizing Agents Cisplatin Therapeutic Uses Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |