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ClinicalTrials.gov Identifier: NCT01822444
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : February 26, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Advanced Colorectal Cancer Other: Biomarker analysis

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).

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Study Type : Observational
Estimated Enrollment : 224 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 2012
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Group/Cohort Intervention/treatment
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
Other: Biomarker analysis

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Validation of identified biomarkers [ Time Frame: 4 years ]
    Validation of identified biomarkers with regard to response rate/failure to further treatment strategy, PFS, overall survival (OS) and toxicity.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study 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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822444

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Sponsors and Collaborators
Cancer Trials Ireland
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Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT01822444    
Other Study ID Numbers: ICORG 12-16
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Cancer Trials Ireland:
Colorectal Cancer
Advanced Colorectal Cancer
Metastatic Colorectal Cancer
Locally Advanced Colorectal Cancer
Colon Cancer
Rectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases