Status:
COMPLETED
Bortezomib, Fluorouracil, Leucovorin, and Oxaliplatin in Treating Patients With Advanced or Metastatic Colorectal Cancer
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from...
Detailed Description
OBJECTIVES: Primary * Determine the dose-limiting toxicity and maximum tolerated dose of bortezomib when administered with fluorouracil, leucovorin calcium, and oxaliplatin in patients with advanced...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed advanced or metastatic colorectal cancer
- Amenable to first-line treatment with oxaliplatin, fluorouracil, and leucovorin calcium for advanced or metastatic disease
- No symptomatic or radiologic evidence of brain metastases
- PATIENT CHARACTERISTICS:
- Age
- Over 18
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 2,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- Renal
- Creatinine ≤ 1.7 mg/dL
- Cardiovascular
- No ischemic heart disease within the past 6 months
- No clinically significant ECG changes
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No baseline neuropathy \> grade 1
- No other prior or concurrent malignancy except cone-biopsied carcinoma of the cervix or adequately treated basal cell or squamous cell skin cancer
- No unstable systemic disease
- No active uncontrolled infection
- No psychological, familial, sociological, or geographical condition that would preclude study participation
- No hypersensitivity to bortezomib, boron, or mannitol
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- No prior oxaliplatin
- No prior chemotherapy for advanced or metastatic disease
- At least 6 months since prior adjuvant chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- More than 4 weeks since prior radiotherapy
- Surgery
- More than 14 days since prior major surgery
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00098982
Start Date
September 1 2004
Last Update
June 12 2013
Active Locations (3)
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1
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, Italy, 80131
2
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
3
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF