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Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach 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 Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach Clinical research trials and Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach 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 Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach. Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach 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 Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach clinical trial. Subjects often receive the most expert healthcare possible for their Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach 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 > "B" Clinical Trials Conditions > Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach  Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach
Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach
For Condition: stage 3 gastric cancer,adenocarcinoma of the stomach,stage 4 gastric cancer,recurrent gastric cancer
Status: Recruiting
Sponsor(s): Cornell University Medical College , National Cancer Institute (NCI)
Synopsis: RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with irinotecan may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of bortezomib with or without irinotecan in treating patients who have unresectable cancer of the gastroesophageal junction or stomach .
Details: OBJECTIVES: - Determine the response rate in patients with previously untreated adenocarcinoma of the gastroesophageal junction or stomach when treated with bortezomib and irinotecan. - Determine the response rate in patients with previously treated adenocarcinoma of the gastroesophageal junction or stomach when treated with bortezomib. - Compare the toxic effects and recovery from these effects in patients treated with these regimens. OUTLINE: Patients are stratified according to prior chemotherapy for advanced disease (yes vs no). - Stratum 1 (Previously untreated patients): Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8. - Stratum 2 (Previously treated patients): Patients receive bortezomib as in stratum 1. In both strata, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 33-58 patients (18-33 previously untreated patients and 15-25 previously treated patients) will be accrued for this study within 12 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 gastroesophageal junction or stomach - Unresectable disease - Unidimensionally measurable disease defined as at least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 6 weeks Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin normal - AST/ALT no greater than 2.5 times upper limit of normal Renal - Creatinine normal 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 contraception - No prior allergic reactions attributed to compounds of similar chemical or biological composition to bortezomib or other agents in study - No other malignancy within the past 5 years except early stage squamous cell skin cancer or carcinoma of the cervix that can be treated locally - No psychiatric illness or social situation that would preclude study compliance - No ongoing active infection - No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - Prior adjuvant chemotherapy for resected disease allowed - No more than 1 prior systemic chemotherapy regimen for advanced disease - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy and recovered - No concurrent radiotherapy Surgery - See Chemotherapy Other - More than 4 weeks since prior photodynamic therapy (except for relieving esophageal obstruction that could not be treated with laser, stent, or dilation) - No concurrent photodynamic therapy - No concurrent commercial or other investigational agents or therapies intended to treat the malignancy - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScottWadler, Study Chair, Cornell University Medical College
Ottawa Regional Cancer Centre *Recruiting*
Ottawa, Ontario, K1H 1C4
Canada
Recruiting Rakesh Goel 613-737-7700 ext. 6254
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
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Xueyu Chen 416-946-2263
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Vincent Vinciguerra 516-562-8955
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Franco Muggia 212-263-6485
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10467
United States
Recruiting Andreas Kaubisch 718-920-7100
Additional Information:
Study ID Numbers: CDR0000302448; NYWCCC-0103672,NCI-5941
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061932
Other Adenocarcinoma Of The Stomach Studies:
1. Aminocamptothecin in Treating Patients With Stomach Cancer or Cancer of the Esophagus
2. Biological Therapy in Treating Patients With Advanced Cancer
3. Neoadjuvant Irinotecan and Cisplatin Followed By Surgical Resection in Treating Patients With Locally Advanced Cancer of the Stomach or Gastroesophageal Junction
4. Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors
5. Surgery With or Without Combination Chemotherapy in Treating Patients With Stomach Cancer
Related Studies:
Other adenocarcinoma of the stomach Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Bortezomib With or Without Irinotecan in Treating Patients With Cancer of the Gastroesophageal Junction or Stomach
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