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Oblimersen, Cisplatin, and Fluorouracil in Treating Patients With Advanced Esophageal, Gastroesophageal Junction, or Stomach Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Oblimersen, Cisplatin, and Fluorouracil in Treating Patients With Advanced Esophageal, Gastroesophageal Junction, or Stomach Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Oblimersen, Cisplatin, and Fluorouracil in Treating Patients With Advanced Esophageal, Gastroesophageal Junction, or Stomach Cancer Clinical research trials and Oblimersen, Cisplatin, and Fluorouracil in Treating Patients With Advanced Esophageal, Gastroesophageal Junction, or Stomach Cancer medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Oblimersen, Cisplatin, and Fluorouracil in Treating Patients With Advanced Esophageal, Gastroesophageal Junction, or Stomach Cancer. Oblimersen, Cisplatin, and Fluorouracil in Treating Patients With Advanced Esophageal, Gastroesophageal Junction, or Stomach Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Oblimersen, Cisplatin, and Fluorouracil in Treating Patients With Advanced Esophageal, Gastroesophageal Junction, or Stomach Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their Oblimersen, Cisplatin, and Fluorouracil in Treating Patients With Advanced Esophageal, Gastroesophageal Junction, or Stomach Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Oblimersen, Cisplatin, and Fluorouracil in Treating Patients With Advanced Esophageal, Gastroesophageal Junction, or Stomach Cancer  Oblimersen, Cisplatin, and Fluorouracil in Treating Patients With Advanced Esophageal, Gastroesophageal Junction, or Stomach Cancer
Oblimersen, Cisplatin, and Fluorouracil in Treating Patients With Advanced Esophageal, Gastroesophageal Junction, or Stomach Cancer
For Condition: Esophageal Cancer,Gastric Cancer
Status: Recruiting
Sponsor(s): Cornell University Medical College , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as cisplatin and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drugs. PURPOSE: Phase I/II trial to study the effectiveness of combining cisplatin and fluorouracil with oblimersen in treating patients who have locally advanced, recurrent, or metastatic cancer of the esophagus, gastroesophageal junction, or stomach.
Details: OBJECTIVES: - Determine the maximum tolerated dose of oblimersen administered with cisplatin and fluorouracil in patients with advanced esophageal, gastroesophageal junction, or gastric cancer. - Determine the toxic effects of this regimen in these patients. - Determine the response rate, time to progression, and median survival of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of oblimersen. - Patients receive oblimersen IV continuously on days 1-7, fluorouracil IV continuously on days 4-8, and cisplatin IV on day 4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive treatment as in phase I with oblimersen at the MTD. PROJECTED ACCRUAL: Approximately 37-85 patients (3-24 for phase I and 34-67 for phase II) will be accrued for this study within 15-18 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, gastroesophageal junction, or stomach - Squamous cell carcinoma of the esophagus also eligible - Locally advanced, recurrent, or metastatic disease not amenable to complete surgical resection or definitive radiotherapy - Clinically evaluable disease - Measurable disease (phase II only) - At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR 10 mm by spiral CT scan - Measurable lesions in a prior radiotherapy field must have documented disease progression - No known brain metastases PATIENT CHARACTERISTICS: Age - Over 18 Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin normal - AST and ALT no greater than 2.5 times upper limit of normal Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception - No prior allergic reaction attributed to compounds of similar chemical or biological composition to antisense oligonucleotides, cisplatin, fluorouracil, or other study agents - No other concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent growth factors during the first course of study therapy Chemotherapy - No more than 1 prior chemotherapy regimen for advanced, recurrent, or metastatic disease - Prior significant full-dose chemotherapy (at least 2 months of therapy) during primary treatment is considered a prior regimen of chemotherapy (unless at least 6 months have elapsed since completion of treatment) - An additional chemotherapy regimen allowed for recurrent or progressive disease more than 6 months after the completion of prior significant chemotherapy - At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - At least 3 weeks since prior radiotherapy and recovered Surgery - Prior surgery allowed Other - More than 4 weeks since prior photodynamic therapy - No prior oblimersen - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients - Concurrent photodynamic therapy for obstruction untreatable by stent, laser, or dilation allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AndreasKaubisch, Study Chair, Albert Einstein Cancer Research Center
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Haralambos Raftopoulos 212-305-0591
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10467
United States
Recruiting Andreas Kaubisch 718-920-4826
Mount Sinai Medical Center, NY *Recruiting*
New York City, New York, 10029
United States
Recruiting Jonathan Schwartz 212-241-3984
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Scott Wadler 212-746-2844
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Vincent Vinciguerra 516-562-8954
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Howard Hochster 212-652-1912
Additional Information:
Study ID Numbers: CDR0000310160; NCI-5835,NYWCCC-0266,AECM-0302032
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064259
Other Esophageal Cancer Studies:
1. A Single Arm, Phase II Study of TNFerade™ gene therapy + Radiation + 5-FU and Cisplatin in Locally Advanced, Resectable, Esophageal Cancer
2. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
3. Triacetyluridine, Fluorouracil, and Leucovorin in Treating Patients With Unresectable, Locally Advanced, or Metastatic Cancer of the Esophagus or Stomach
4. Eflornithine to Prevent Cancer in Patients With Barrett's Esophagus
5. Irinotecan and Capecitabine in Treating Patients With Solid Tumors
Related Studies:
Other Esophageal Cancer Clinical Trials
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Other New York City Clinical Trials
Oblimersen, Cisplatin, and Fluorouracil in Treating Patients With Advanced Esophageal, Gastroesophageal Junction, or Stomach Cancer
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