ANGIOPREDICT. ICORG 12-16, V3
This trial is active, not recruiting.
|Condition||advanced colorectal cancer|
|Sponsor||Cancer Trials Ireland|
|Start date||November 2012|
|End date||October 2017|
|Trial size||224 participants|
|Trial identifier||NCT01822444, ICORG 12-16|
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).
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Speyer, Germany||Private Practice Oncology||no longer recruiting|
|Aachen, Germany||Medizinische Klinik III, Universitaetsklinikum||no longer recruiting|
|Deggendorf, Germany||Onkologisches Zentrum||no longer recruiting|
|Homburg, Germany||University Hospital Saarland||no longer recruiting|
|Lebach, Germany||Gemeinschaftspraxis Haematologie/Onkologie||no longer recruiting|
|Ludwigsburg, Germany||Kilnikum Ludwigsburg||no longer recruiting|
|Mainz, Germany||Medizinische Klinik and Poliklinik Mainz||no longer recruiting|
|Mannheim, Germany||Univeritaetsmedizin Mannheim||no longer recruiting|
|Cork, Ireland||Bon Secours Hospital||no longer recruiting|
|Cork, Ireland||Cork University Hospital||no longer recruiting|
|Dublin, Ireland||St Vincent's University Hospital||no longer recruiting|
|Dublin, Ireland||Beaumont Hospital||no longer recruiting|
|Dublin, Ireland||St James Hospital||no longer recruiting|
|Dublin, Ireland||The Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital||no longer recruiting|
|Galway, Ireland||Galway University Hospital||no longer recruiting|
|Sligo, Ireland||Sligo General Hospital||no longer recruiting|
|Waterford, Ireland||Waterford Regional Hospital||no longer recruiting|
Advanced Colorectal Cancer with planned treatment with a aCRC or mCRC and who fulfil all inclusion and exclusion criteria
Identification of biomarkers
time frame: 4 years
Validation of identified biomarkers
time frame: 4 years
Male or female participants at least 18 years old.
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.
|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|
|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).|
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