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3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about 3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. 3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction Clinical research trials and 3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as 3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction. 3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a 3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction clinical trial. Subjects often receive the most expert healthcare possible for their 3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "3" Clinical Trials Conditions > 3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction  3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
For Condition: recurrent esophageal cancer,stage 4 esophageal cancer,Adenocarcinoma of the Esophagus
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: 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: Phase II trial to study the effectiveness of combining 3-AP with cisplatin in treating patients who have recurrent or metastaticadenocarcinoma of the esophagus or gastroesophageal junction.
Details: OBJECTIVES: Primary - Determine the objective response rate in patients with recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with 3-AP (Triapine^® ) and cisplatin. Secondary - Determine the toxicity of this regimen in these patients. - Determine the duration of response and overall survival of patients treated with this regimen. - Determine the palliative benefits with regard to dysphagia in patients treated with this regimen. 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction - Metastatic or recurrent disease - Measurable disease - At least 1 unidimensionally measurable lesion 20 mm by conventional techniques OR 10 mm by spiral CT scan - Outside prior irradiation port - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 50-100% Life expectancy - More than 6 months Hematopoietic - Absolute neutrophil count 1,500/mm^3 - WBC 3,000/mm ^3 - Platelet count 100,000/mm^3 Hepatic - AST and ALT 2.5 times upper limit of normal - Bilirubin normal Renal - Creatine normal OR - Creatinine clearance 50 mL/min Cardiovascular - No prior myocardial infarction - No unstable angina - No cardiac arrhythmia - No uncontrolled congestive heart failure Pulmonary - No pulmonary disease requiring supplemental oxygen Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - No G6PD deficiency - No other concurrent uncontrolled illness - No active or ongoing infection - No active second malignancy - No prior allergic reaction to compounds of similar chemical or biological composition to 3-AP or other study agents - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 1 year since prior platinum-derivative agents - No prior chemotherapy for metastatic or recurrent esophageal cancer Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - At least 2 weeks since prior radiotherapy and recovered Surgery - Not specified Other - No other concurrent anticancer therapy - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnnMauer, Study Chair, University of Chicago Cancer Research Center
Oncology/Hematology Associates of Central Illinois, P.C. *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting James Knost 309-672-5681
Medical College of Wisconsin Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Stuart Wong 414-805-4603
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting David Taber 800-284-7370
Ingalls Memorial Hospital *Recruiting*
Harvey, Illinois, 60426
United States
Recruiting Mark Kozloff 708-333-2300
Oncology Care Associates, P.L.L.C. *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-985-0029
Evanston Northwestern Health Care - Evanston Hospital *Recruiting*
Evanston, Illinois, 60201-1781
United States
Recruiting Bruce Brockstein 847-570-1489
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Everett Vokes 773-834-3093
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting David Sciortino 219-484-8830
Central Illinois Hematology Oncology Center *Recruiting*
Springfield, Illinois, 62701
United States
Recruiting Edem Agamah 217-525-2500
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting Ellen Gaynor 708-327-3101
Decatur Memorial Hospital Cancer Care Institute *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6603
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1009
United States
Recruiting Gerald Clamon 319-356-8110
Additional Information:
Study ID Numbers: CDR0000352307; NCI-6285,UCCRC-12765A
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077545
Other Stage 4 Esophageal Cancer Studies:
1. Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
2. Irinotecan in Treating Patients With Advanced Cancer of the Stomach
3. Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus
4. Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
5. Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
Related Studies:
Other stage 4 esophageal cancer Clinical Trials
Other Iowa Clinical Trials
Other Iowa City Clinical Trials
3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
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