Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Bevacizumab

Capecitabine

Erlotinib Hydrochloride

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

bevacizumab 7.5 mg/kg body weight every third week, erlotinib 150 mg daily

bevacizumab, erlotinib

bevacizumab 7.5 mg/kg body weight every third week

bevacizumab

bevacizumab 7.5 mg/kg body weight every third week.

low dose capecitabine

Patients with metastatic colorectal cancer will be treated with chemotherapy according to investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the patients KRAS status will be tested. After having fulfilled these 18 weeks of induction treatment, patients who has responded (complete response/partial response versus stable disease) will be randomized to maintenance treatment. Patients with KRAS WT will be randomized to either bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS mutation will be randomized to either bevacizumab, or metronomic capecitabine. Translational research is performed, with purpose to find predictive factors in blood and tumor tissue.

Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.

Hoffmann-La Roche

Lund University Hospital

Symptoms and General Pathology

Neoplasm Metastasis

Disease Progression

Liver Neoplasms

Neoplastic Processes

Liver Diseases

Micronutrients

Hematinics

Vitamins

Oxaliplatin

Leucovorin

Fluorouracil

Levoleucovorin

Aflibercept

Folic Acid

Liver Extracts

Folinic Acid

Folate

Vitamin B9

6 cycles before and 6 cycles after surgery consisting in:

Hour 0: Oxaliplatin 85 mg/m² IV 2-h infusion

Hour 0: Folinic Acid 400 mg/m² (DL form) or 200 mg/m2 (L form) IV 2-h infusion

Hour 2: 5-FU 400 mg/m² IV bolus over 2-4 minutes

Hour 2: 5-FU 2400 mg/m² given as a continuous infusion over 46h.

On day 1 of a 14 day cycle

6 cycles before and 6 cycles after surgery consisting in:

Hour 0: Aflibercept 4 mg/kg intravenous infusion 1-h

Hour 1: Oxaliplatin 85 mg/m2 2-h infusion

Hour 1: Folinic Acid 400 mg/m2 (DL form) or 200 mg/m2 (L form) 2-h infusion

Hour 3: 5-FU bolus 400 mg/m2 IV bolus over 2-4 minutes

Hour 3: 5-FU 2400 mg/m² given as a continuous infusion over 46h.

Day 1 of a 14 day cycle

Aflibercept should be given in all cycles, except cycle 6 of pre-operative treatment.

Modified FOLFOX6

Surgery

Bernard Nordlinger, Pr.

Patients presenting with multiple innumerable liver metastases will probably never come to resection, however, for all others, including patients with numerous multiple metastases or large metastases, resection should be considered after limited chemotherapy.

There is consensus for a backbone chemotherapy consisting of fluoropyrimidine + oxaliplatin. FOLFOX was used in the previous EORTC study and is again recommended.

The addition of targeted agents to standard chemotherapy in the perioperative strategy for mCRC might increase the ORR and R0 resectability, without significant increase in toxicity, therefore translating to a better outcome.

BOS2 (EORTC 40091) was designed to test this hypothesis in patients with a KRAS wold-type profile.

It was decided in parallel to design an open label, randomized, multi-center, 2-arm phase II-III study this time aimed at enrolling KRAS mutated patients.

Arm A: (standard) mFOLFOX6 + Surgery Arm B: (experimental) mFOLFOX6 + Aflibercept + Surgery

Efficacy of FOLFOX Versus FOLFOX Plus Aflibercept in K-ras Mutant Patients With Resectable Liver Metastases

BOS3: Randomized Phase II/III Trial Evaluating the Efficacy of FOLFOX Alone Versus FOLFOX Plus Aflibercept in K-ras Mutant as Perioperative Treatment in Patients With Resectable Liver Metastases From Colorectal Cancer.

Increase in progression free survival rate at 1 year in the experimental arm (mFOLFOX6 + aflibercept) compared to mFOLFOX6 alone arm.

Increase in major pathological response rate between mFOLFOX6 alone arm and each experimental arm.

Compare the percentage of patients with total resection with these three treatments.

Overall survival is defined as the time interval between the date of randomization and the date of death. Patients who are still alive when last traced will be censored at the date of last follow-up.

All adverse events will be recorded; the investigator will assess whether those events are drug related (reasonable possibility, no reasonable possibility) and this assessment will be recorded in the database for all adverse events.

Sanofi

European Organisation for Research and Treatment of Cancer - EORTC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.	NCT01229813	Colorectal Canc...	bevacizumab, er... bevacizumab bevacizumab low dose capeci...	18 Years -	Lund University Hospital
Efficacy of FOLFOX Versus FOLFOX Plus Aflibercept in K-ras Mutant Patients With Resectable Liver Metastases	NCT01646554	Colorectal Canc... Liver Metastase... KRAS Mutated Co...	Modified FOLFOX... Aflibercept Surgery	18 Years - 75 Years	European Organisation for Research and Treatment of Cancer - EORTC
Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.	NCT01229813	Colorectal Canc...	bevacizumab, er... bevacizumab bevacizumab low dose capeci...	18 Years -	Lund University Hospital

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