ANGIOPREDICT. ICORG 12-16, V3

Completed

• Conditions: Advanced Colorectal Cancer
• Interventions: Other: Biomarker analysis

• Registration Number: NCT01822444
• Lead Sponsor: Cancer Trials Ireland

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:

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.

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:

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 Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-02-25
• Study First Submitted QC: 2013-03-27
• Study First Posted: 2013-04-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intent-to-treat population with aCRC or mCRC	Biomarker analysis	Advanced Colorectal Cancer with planned treatment with a aCRC or mCRC and who fulfil all inclusion and exclusion criteria

Primary Outcome Measures

Name	Time	Method
Identification of biomarkers	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 Outcome Measures

Name	Time	Method
Validation of identified biomarkers	4 years	Validation of identified biomarkers with regard to response rate/failure to further treatment strategy, PFS, overall survival (OS) and toxicity.

Trial Locations

Locations (17)

Bon Secours Hospital; 🇮🇪 Cork, Ireland

Sligo General Hospital; 🇮🇪 Sligo, Ireland

St Vincent's University Hospital; 🇮🇪 Dublin, Ireland

The Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital; 🇮🇪 Dublin, Ireland

Waterford Regional Hospital; 🇮🇪 Waterford, Ireland

Cork University Hospital; 🇮🇪 Cork, Ireland

Beaumont Hospital; 🇮🇪 Dublin, Ireland

St James Hospital; 🇮🇪 Dublin, Ireland

Galway University Hospital; 🇮🇪 Galway, Ireland

University Hospital Saarland; 🇩🇪 Homburg, Germany

Private Practice Oncology; 🇩🇪 Speyer, Rhineland-Palatinate, Germany

Medizinische Klinik III, Universitaetsklinikum; 🇩🇪 Aachen, Germany

Onkologisches Zentrum; 🇩🇪 Deggendorf, Germany

Gemeinschaftspraxis Haematologie/Onkologie; 🇩🇪 Lebach, Germany

Kilnikum Ludwigsburg; 🇩🇪 Ludwigsburg, Germany

Medizinische Klinik and Poliklinik Mainz; 🇩🇪 Mainz, Germany

Univeritaetsmedizin Mannheim; 🇩🇪 Mannheim, Germany