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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced Colorectal Cancer

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Trial Information

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


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).


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.

3. K-ras mutation status.

4. Planned treatment of and naive for oxaliplatin plus fluorouracil/leucovorin (FOLFOX)
in combination with bevacizumab (bvz).

5. At least one evaluable site of disease according to RECIST criteria.

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. Tissue obtained from archive and/or during a standard resection or biopsy procedure.

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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Identification of biomarkers

Outcome Description:

Identification of biomarkers, which are predictive for response and/or prolonged PFS to FOLFOX/bvz combination therapy in aCRC or mCRC patients.

Outcome Time Frame:

4 years

Safety Issue:

No

Authority:

Ireland: Health Information and Quality Authority

Study ID:

ICORG 12-16

NCT ID:

NCT01822444

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Advanced Colorectal Cancer
  • Colorectal Cancer
  • Advanced Colorectal Cancer
  • Metastatic Colorectal Cancer
  • Locally Advanced Colorectal Cancer
  • Colon Cancer
  • Rectal Cancer
  • Colorectal Neoplasms

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