This trial is active, not recruiting.

Condition advanced colorectal cancer
Treatment biomarker analysis
Sponsor Cancer Trials Ireland
Start date November 2012
End date October 2017
Trial size 224 participants
Trial identifier NCT01822444, ICORG 12-16


Primary Objective:

The primary objective is to validate previously identified predictive/prognostic genomic DNA and expression biomarkers of response to combination bvz treatments in K-ras mutant advanced CRC (a CRC) or metastatic CRC (mCRC).

Secondary Objective:

1. To test the efficacy of bvz in combination with FOLFOX in patients with newly diagnosed advanced or metastatic K-ras mutant CRC and

2. To determine the progression free and overall survival of patients under first line FOLFOX + bvz in aCRC or mCRC.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Advanced Colorectal Cancer with planned treatment with a aCRC or mCRC and who fulfil all inclusion and exclusion criteria
biomarker analysis

Primary Outcomes

Identification of biomarkers
time frame: 4 years

Secondary Outcomes

Validation of identified biomarkers
time frame: 4 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patients ≥ 18 years of age. 2. Patients diagnosed with recurrent or de novo, locally advanced (unresectable) or metastatic adenocarcinoma of the colon or rectum. 3. Planned combination bevacizumab (bvz) treatment with either: - leucovorin, fluorouracil and oxaliplatin (FOLFOX) - capecitabine and oxaliplatin (XELOX) - leucovorin, fluorouracil and irinotecan (FOLFIRI) - capecitabine and irinotecan (XELIRI) 4. Naive for bvz 5. An evaluable site of disease 6. ECOG Performance status 0, 1, or 2 7. Adequate renal function as shown by serum creatinine ≤ 1.5 x ULN or GFR ≥ 50ml/min 8. Adequate hematopoietic function [white blood cell (WBC) count ≥ 3000/μl, absolute neutrophil count (ANC) ≥1500/μl, platelets ≥100 000/μl, haemoglobin level ≥ 9.0 g/dl] 9. Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 3.0 x ULN (in case of liver metastases SGOT and SGPT < 5.0 x ULN) 10. Ability to give signed informed consent prior to any screening procedures 11. FFPE Tissue is available Exclusion Criteria: 1. Patient has received any other investigational product within 28 days of first day of study drug dosing 2. Patients having familial and/or hereditary CRC 3. CRC associated with ulcerative colitis 4. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

Additional Information

Official title Exploratory Phase II Clinical Trial Comprising Biomarker Analysis of Oxaliplatin Plus Fluorouracil/Leucovorin (FOLFOX) in Combination With Bevacizumab (Bvz) in First Line Treatment of Metastatic Colorectal Cancer (CRC) Expressing Mutant K-ras - AC-ANGIOPREDICT
Description Study Design: Type of Study: Exploratory, translational, multicenter and multinational Phase II study. Patient Population:All patients from the intent-to-treat population with aCRC or mCRC, (incurable with any conventional multimodality approach) and who fulfil all inclusion and exclusion criteria. Number of Patients: 224 Sample Type: Serial tissue and blood samples will be collected before (week 0), during (week 6, month 3 and 6) and at the end of treatment (month 12).
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Cancer Trials Ireland.