ANGIOPREDICT. ICORG 12-16, V3

Cancer Trials Ireland76 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Advanced Colorectal Cancer

Interventions

Biomarker analysisOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (17)

Private Practice Oncology

Speyer, Rhineland-Palatinate, Germany

Medizinische Klinik III, Universitaetsklinikum

Aachen, Germany

Onkologisches Zentrum

Outcomes

Primary Outcomes

Identification of biomarkers

Identification of biomarkers, which are predictive for response and/or prolonged PFS to FOLFOX/bvz combination therapy in aCRC or mCRC patients.

Time frame: 4 years

Secondary Outcomes

Validation of identified biomarkers

Validation of identified biomarkers with regard to response rate/failure to further treatment strategy, PFS, overall survival (OS) and toxicity.

Time frame: 4 years

Data from ClinicalTrials.gov

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