Clinical trial NCT01822444: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Colorectal Cancer
Keywords: Colorectal Cancer
Advanced Colorectal Cancer
Metastatic Colorectal Cancer
Locally Advanced Colorectal Cancer
Colon Cancer
Rectal Cancer
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2013-04-02
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Primary outcomes:
measure: Identification of biomarkers
timeFrame: 4 years
Secondary outcomes:
measure: Validation of identified biomarkers
timeFrame: 4 years
Other outcomes:
Locations:
city: Speyer
country: Germany
facility: Private Practice Oncology
state: Rhineland-Palatinate
city: Aachen
country: Germany
facility: Medizinische Klinik III, Universitaetsklinikum
city: Deggendorf
country: Germany
facility: Onkologisches Zentrum
city: Homburg
country: Germany
facility: University Hospital Saarland
city: Lebach
country: Germany
facility: Gemeinschaftspraxis Haematologie/Onkologie
city: Ludwigsburg
country: Germany
facility: Kilnikum Ludwigsburg
city: Mainz
country: Germany
facility: Medizinische Klinik and Poliklinik Mainz
city: Mannheim
country: Germany
facility: Univeritaetsmedizin Mannheim
city: Cork
country: Ireland
facility: Bon Secours Hospital
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: St James Hospital
city: Dublin
country: Ireland
facility: The Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
city: Galway
country: Ireland
facility: Galway University Hospital
city: Sligo
country: Ireland
facility: Sligo General Hospital
city: Waterford
country: Ireland
facility: Waterford Regional Hospital
Study officials:
References: