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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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 also help doctors select the best treatment for patients and predict their response to treatment.

PURPOSE: This randomized phase II/III trial is studying how well tumor tissue testing works in selecting treatment for patients with metastatic or locally advanced colorectal cancer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Research Council
• Treatments: Bevacizumab; Calcium; Cetuximab; Fluorouracil; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

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