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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cancer Trials Ireland
- Enrollment
- 76
- Locations
- 17
- Primary Endpoint
- Identification of biomarkers
Study Overview
Brief Summary
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:
- To test the efficacy of bvz in combination with FOLFOX in patients with newly diagnosed advanced or metastatic K-ras mutant CRC and
- To determine the progression free and overall survival of patients under first line FOLFOX + bvz in aCRC or mCRC.
Detailed 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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients ≥ 18 years of age.
- •Patients diagnosed with recurrent or de novo, locally advanced (unresectable) or metastatic adenocarcinoma of the colon or rectum.
- •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)
- •Naive for bvz
- •An evaluable site of disease
- •ECOG Performance status 0, 1, or 2
- •Adequate renal function as shown by serum creatinine ≤ 1.5 x ULN or GFR ≥ 50ml/min
- •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]
- •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)
- •Ability to give signed informed consent prior to any screening procedures
- •FFPE Tissue is available
Exclusion Criteria
- •Patient has received any other investigational product within 28 days of first day of study drug dosing
- •Patients having familial and/or hereditary CRC
- •CRC associated with ulcerative colitis
- •Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
Arms & Interventions
Intent-to-treat population with aCRC or mCRC
Advanced Colorectal Cancer with planned treatment with a aCRC or mCRC and who fulfil all inclusion and exclusion criteria
Intervention: Biomarker analysis (Other)
Outcomes
Primary Outcomes
Identification of biomarkers
Time Frame: 4 years
Identification of biomarkers, which are predictive for response and/or prolonged PFS to FOLFOX/bvz combination therapy in aCRC or mCRC patients.
Secondary Outcomes
- Validation of identified biomarkers(4 years)