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Status:

COMPLETED

Study of Tumor Tissue Testing in Selecting Treatment for Patients With Metastatic or Locally Advanced Colorectal Cancer

Lead Sponsor:

Medical Research Council

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may al...

Detailed Description

OBJECTIVES: Primary - Feasibility Study * To determine the proportion of consenting patients that can provide a formalin-fixed paraffin-embedded block containing tumor. * To determine the feasibilit...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed colorectal adenocarcinoma meeting 1 of the following criteria:
  • Prior or recurrent primary adenocarcinoma of the colon or rectum with clinical or radiological evidence of locally advanced or metastatic disease
  • Metastatic adenocarcinoma with clinical and/or radiological evidence of colorectal primary tumor
  • Inoperable metastatic or locoregional disease
  • Patients suitable for surgical resection of metastatic disease after response to first-line or adjuvant chemotherapy not allowed and should be considered for the New-EPOC trial study
  • Unidimensionally measurable disease (according to RECIST criteria)
  • Must have completed adjuvant chemotherapy with fluorouracil +/- leucovorin calcium (FU +/- LC), capecitabine, or oxaliplatin combinations in the past 6 months
  • QUASAR 2 patients who have continued bevacizumab for 6 months following completion of chemotherapy are allowed immediately after completion of bevacizumab
  • Rectal chemotherapy with FU +/- LC or capecitabine for allowed if completed ≥ 1 month ago
  • Single tumor block available
  • No brain metastasis
  • PATIENT CHARACTERISTICS:
  • WHO performance status 0-2
  • ANC ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
  • Serum bilirubin ≤ 1.25 times ULN
  • AST or ALT ≤ 2.5 times ULN
  • Creatinine clearance ≥ 30 mL/min OR GFR ≥ 30 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Considered fit to undergo combination chemotherapy, with none of the following conditions:
  • Severe uncontrolled concurrent medical illness likely to interfere with protocol treatments, including any of the following:
  • Poorly controlled angina
  • Uncontrolled hypertension
  • Myocardial infarction within the past 3 months
  • History of severe peptic ulcer disease
  • Any psychiatric or neurological condition that is likely to compromise the patient's ability to give informed consent or to comply with oral medication
  • Nephrotic syndrome
  • Known coagulopathy
  • No prior or current malignant disease that, in the judgement of the treating investigator, is likely to interfere with FOCUS 3 treatment or assessment of response
  • No known hypersensitivity reactions to any of the components of the study treatments
  • No personal or family history suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency or with known DPD deficiency
  • No history of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant precluding informed consent
  • Not able to attend or comply with treatment or follow-up scheduling
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • At least 4 weeks since prior surgery
  • No prior systemic chemotherapy for metastatic disease
  • No ongoing therapy with cyclosporin-A
  • No ongoing treatment with a contraindicated concomitant medication

Exclusion

    Key Trial Info

    Start Date :

    July 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2012

    Estimated Enrollment :

    3240 Patients enrolled

    Trial Details

    Trial ID

    NCT00975897

    Start Date

    July 1 2009

    End Date

    December 1 2012

    Last Update

    December 19 2013

    Active Locations (3)

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

    Page 1 of 1 (3 locations)

    1

    Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, United Kingdom, LS9 7TF

    2

    Belfast City Hospital Trust Incorporating Belvoir Park Hospital

    Belfast, Northern Ireland, United Kingdom, BT8 8JR

    3

    Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, United Kingdom, CF14 2TL