Study of Tumor Tissue Testing in Selecting Treatment for Patients With Metastatic or Locally Advanced Colorectal Cancer
Colorectal Cancer
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, recurrent colon cancer, stage III colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer
Eligibility 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
Sites / Locations
- Leeds Cancer Centre at St. James's University Hospital
- Belfast City Hospital Trust Incorporating Belvoir Park Hospital
- Velindre Cancer Center at Velindre Hospital