ANGIOPREDICT. ICORG 12-16, V3

Cancer Trials Ireland

Status: Completed

Conditions: Advanced Colorectal Cancer

Treatments: Other: Biomarker analysis

Study type: Observational

Funder types: NETWORK

Identifiers

NCT01822444

ICORG 12-16

Details and patient eligibility

About

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.

Full 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).

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

76 participants in 1 patient group

Intent-to-treat population with aCRC or mCRC

Description:

Advanced Colorectal Cancer with planned treatment with a aCRC or mCRC and who fulfil all inclusion and exclusion criteria

Treatment:

Other: Biomarker analysis