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ANGIOPREDICT. ICORG 12-16, V3

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01822444
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Cancer Trials Ireland

Tracking Information
First Submitted Date February 25, 2013
First Posted Date April 2, 2013
Last Update Posted Date February 26, 2020
Actual Study Start Date November 2012
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2013)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 27, 2013)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ANGIOPREDICT. ICORG 12-16, V3
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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Advanced Colorectal Cancer
Intervention Other: Biomarker analysis
Study Groups/Cohorts 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: Other: Biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: March 27, 2013)
224
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   Ireland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01822444
Other Study ID Numbers ICORG 12-16
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Cancer Trials Ireland
Original Responsible Party Same as current
Current Study Sponsor Cancer Trials Ireland
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Cancer Trials Ireland
Verification Date February 2020