Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    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