Status:
COMPLETED
ANGIOPREDICT. ICORG 12-16, V3
Lead Sponsor:
Cancer Trials Ireland
Conditions:
Advanced Colorectal Cancer
Eligibility:
All Genders
18+ years
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 adv...
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, (incurab...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years of age.
- Patients diagnosed with recurrent or de novo, locally advanced (unresectable) or metastatic adenocarcinoma of the colon or rectum.
- 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)
- Naive for bvz
- An evaluable site of disease
- ECOG Performance status 0, 1, or 2
- Adequate renal function as shown by serum creatinine ≤ 1.5 x ULN or GFR ≥ 50ml/min
- Adequate hematopoietic function \[white blood cell (WBC) count ≥ 3000/μl, absolute neutrophil count (ANC) ≥1500/μl, platelets ≥100 000/μl, haemoglobin level ≥ 9.0 g/dl\]
- 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)
- Ability to give signed informed consent prior to any screening procedures
- FFPE Tissue is available
Exclusion
- Patient has received any other investigational product within 28 days of first day of study drug dosing
- Patients having familial and/or hereditary CRC
- CRC associated with ulcerative colitis
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01822444
Start Date
November 1 2012
End Date
February 1 2017
Last Update
April 6 2023
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Private Practice Oncology
Speyer, Rhineland-Palatinate, Germany
2
Medizinische Klinik III, Universitaetsklinikum
Aachen, Germany
3
Onkologisches Zentrum
Deggendorf, Germany
4
University Hospital Saarland
Homburg, Germany