Status:
COMPLETED
Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
OBJECTIVES: Primary * Determine the efficacy of bortezomib in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Secondary * Determine the toxicity of th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00074009
Start Date
October 1 2003
Last Update
February 14 2012
Active Locations (4)
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1
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
2
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
3
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
4
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-3236