NCT00103103TerminatedPhase 2
A Phase II Combination Trial of PS-341 and 5-FU/LV in Gastric and/or GE Junction Adenocarcinoma
California Cancer Consortium10 sites in 1 countryStarted: March 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Locations
- 10
- Primary Endpoint
- Response rate as measured by RECIST every 8 weeks
Study Overview
Brief Summary
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with fluorouracil and leucovorin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with fluorouracil and leucovorin works in treating patients with metastatic or unresectable stomach cancer.
Detailed Description
OBJECTIVES:
Primary
- Determine response in patients with previously treated metastatic or unresectable gastric or gastroesophageal junction adenocarcinoma treated with bortezomib, fluorouracil, and leucovorin calcium.
Secondary
- Determine time to progression and overall survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Diagnosis of gastric or gastroesophageal junction adenocarcinoma
- •Metastatic or unresectable disease
- •Progressive disease after receiving 1 prior chemotherapy regimen for metastatic disease comprising 1 of the following:
- •Fluorouracil
- •Cisplatin and irinotecan
- •Capecitabine
- •Measurable disease
- •No esophageal cancer
- •No brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin normal
- •AST and ALT ≤ 2.5 times upper limit of normal
- •Creatinine ≤ 1.5 mg/dL
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No acute ischemia by EKG
- •No significant conduction abnormality by EKG, including either of the following:
- •Bifasicular block, defined as left anterior hemiblock in the presence of right bundle branch block
- •Second or third degree atrioventricular block
- •No history of cardiac or cerebrovascular disease due to hypotension and tachycardia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception before, during, and for 6 months after study participation
- •No ongoing or active infection
- •No other uncontrolled illness
- •No peripheral neuropathy ≥ grade 2 within the past 2 weeks
- •No allergy to boron or mannitol
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 4 weeks since prior immunotherapy
- •Chemotherapy
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •More than 4 weeks since prior radiotherapy and recovered
- •More than 2 weeks since prior major surgery
- •No concurrent highly active anti-retroviral therapy for HIV-positive patients
- •No other concurrent investigational agents
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Response rate as measured by RECIST every 8 weeks
Secondary Outcomes
- Time to progression every 8 weeks
- Overall survival
- Toxicity every 4 weeks
- Molecular correlates on and off study treatment
Investigators
Study Sites (10)
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