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Home > "B" Clinical Trials Conditions > Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma  Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
For Condition: recurrent gastric cancer,stage 4 gastric cancer,adenocarcinoma of the stomach,stage 3 gastric cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have unresectable or metastaticgastric cancer or gastroesophageal junctionadenocarcinoma.
Details: OBJECTIVES: Primary - Determine the efficacy of bortezomib in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Secondary - Determine the toxicity of this drug in these patients. - Determine possible predictors of response to this drug, using pretreatment tumor immunohistochemistry, in these patients. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 15-33 patients will be accrued for this study within 5-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma - Siewert’s class II or III disease - Measurable disease - At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - No history of known or active brain metastases or primary brain tumors PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% OR - ECOG 0-2 Life expectancy - Not specified Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL - AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Renal - Creatinine no greater than 1.5 mg/dL Cardiovascular - No prior cerebrovascular event - No prior orthostatic hypotension - No myocardial infarction within the past 6 months - No peripheral vascular disease requiring surgical management - No evidence of acute ischemia or significant conduction abnormality by EKG Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 2 months after study participation - No evidence of peripheral neuropathy - No prior allergic reaction attributed to compounds of similar chemical or biological composition to bortezomib - No other malignancy within the past 3 years except basal cell skin cancer, carcinoma in situ of the cervix, or adequately treated nonmetastatic prostate cancer - No ongoing or active infection - No psychiatric illness or social situation that would preclude study participation - No other concurrent uncontrolled illness that would preclude study participation - No other medical condition or reason that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - More than 3 weeks since prior immunotherapy - No concurrent biological or immunological agents Chemotherapy - No more than 1 prior chemotherapy regimen (including adjuvant chemotherapy) - More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - More than 3 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - Recovered from all prior therapy - No other concurrent investigational agents - No other concurrent anticancer agent or therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ManishShah, Principal Investigator, Memorial Sloan-Kettering Cancer Center
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-3236
United States
Recruiting Kyle Holen 608-265-6222
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Manish Shah 212-639-3113
Queens Cancer Center of Queens Hospital *Recruiting*
Jamaica, New York, 11432
United States
Recruiting Mary Kemeny 718-883-4031
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Deepti Singh 773-702-5507
Additional Information:
Study ID Numbers: CDR0000341565; NCI-6003,MSKCC-03101
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074009
Other Recurrent Gastric Cancer Studies:
1. Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
2. Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer
3. Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
4. Imatinib Mesylate in Treating Patients With Refractory Metastatic and/or Unresectable Stomach Cancer
5. Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus
Related Studies:
Other recurrent gastric cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
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