ANGIOPREDICT. ICORG 12-16, V3

Advanced Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01822444
• Other study ID #: ICORG 12-16
• Status: Completed
• Start date: November 2012
• Est. completion date: February 2017

Study information

• Verified date: April 2023
• Source: Cancer Trials Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Biomarker analysis

Locations

Country	Name	City	State
Germany	Medizinische Klinik III, Universitaetsklinikum	Aachen
Germany	Onkologisches Zentrum	Deggendorf
Germany	University Hospital Saarland	Homburg
Germany	Gemeinschaftspraxis Haematologie/Onkologie	Lebach
Germany	Kilnikum Ludwigsburg	Ludwigsburg
Germany	Medizinische Klinik and Poliklinik Mainz	Mainz
Germany	Univeritaetsmedizin Mannheim	Mannheim
Germany	Private Practice Oncology	Speyer	Rhineland-Palatinate
Ireland	Bon Secours Hospital	Cork
Ireland	Cork University Hospital	Cork
Ireland	Beaumont Hospital	Dublin
Ireland	St James Hospital	Dublin
Ireland	St Vincent's University Hospital	Dublin
Ireland	The Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital	Dublin
Ireland	Galway University Hospital	Galway
Ireland	Sligo General Hospital	Sligo
Ireland	Waterford Regional Hospital	Waterford

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Trials Ireland

Countries where clinical trial is conducted

Germany,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 years
Secondary	Validation of identified biomarkers	Validation of identified biomarkers with regard to response rate/failure to further treatment strategy, PFS, overall survival (OS) and toxicity.	4 years