A Phase III Study Evaluating the Role of Perioperative Chemotherapy and Bevacizumab in Patients with Potentially Resectable Hepa - Genesis HealthCare System - Zanesville, Ohio

Role of Perioperative Chemotherapy and Bevacizumab

A Phase III Study Evaluating the Role of Perioperative Chemotherapy and Bevacizumab in Patients with Potentially Resectable Hepatic Colorectal Metastases

Objective

Patients who have not previously received oxaliplatin will receive Mfolfox^ (groups 1A and 2A); those who have previously received oxaliplatin will receive FOLFIRI (Groups 1B and 2B)

Group 1A m FOLFOX6

Hepatic Resection prior to chemo: Oxaliplatin 85mg/m2 and Leucovorin 400mg/m2 given concurrently over 2 hours. 5-Fu (bolus) 400mg/m2, and 5-FU (infusion)2400mg/m2 over 46 hours. Day 1 every 2 weeks. Cycles 1-12

Group 2A mFOLFOX6

Oxaliplatin 85mg/m2 and Leucovorin 400mg/m2 given concurrently over 2 hours. 5-Fu (bolus) 400mg/m2, and 5-FU (infusion)2400mg/m2 over 46 hours. Day 1 every 2 weeks. Cycles 1-6. Hepatic resection .Post -op chemo: Oxaliplatin 85mg/m2 and Leucovorin 400mg/m2 given concurrently over 2 hours. 5-Fu (bolus) 400mg/m2, and 5-FU (infusion)2400mg/m2 over 46 hours. Day 1 every 2 weeks. Cycles 7-12.

Group 1B FOLFIRI

Hepatic resection prior to chemo: Irinotecan 180mg/m2 and Leucovorin 400mg/m2 given concurrently over 2 hours. 5-Fu (bolus) 400mg/m2. 5-FU (infusion)2400mg/m2 over 46 hours. Day 1 every 2 weeks. Cycles 1-12.

Group 2B FOLFIRI

Irinotecan 180mg/m2and Leucovorin 400mg/m2 given concurrently over 2 hours. 5-FU (bolus) 400mg/m2. 5-FU (infusion) 2400mg/m2 over 46 hours. Day 1 every 2 weeks. Cycles 1-6. Hepatic Resection. Post-op chemo: Irinotecan 180mg/m2 and Leucovorin 400mg/m2 given concurrently over 2 hours. 5-FU (bolus) 400mg/m2. 5-FU (infusion)24oomg/m2 over 46 hours. Day 1 every 2 weeks. Cycle 7-12.

 

ELIGIBILITY

1) Histologic confirmation of a diagnosisof colorectal adenocarcinoma. Histologic confirmation of hepatic metastasis is not required.

2) Preferred imaging: PET-CT with contrast or PET scan and CT scan with contrast performed within 4 weeks prior to randomization must demonstrate: Hepatic metastasis and no evidence of extrahepatic metastatic disease.

3) Eligibility with any of the following: primary tumor and regional nodes resected with clear surgical margins and no evidence of extrahepatic disease or unresected primary tumor with plans to resect the primary tumor prior to randomization or unresected primary tumor with plans to resect the primary tumor and the liver metastases in a single procedure performed after randomization.

4) Within 4 weeks prior to randomization the liver metastases must have been determined by hepatic surgeon to be respectable based on both of the following:

                     a) a complete resection can be performed in a single operation

                     b) there are at least two uninvolved contiguous segments of the liver

 

 

INELIGIBILITY

1) Diagnosis of anal, small bowel, or appendiceal carcinoma

2) Colorectal malignant diseases other than adenocarcinoma

3) Unresectable primary tumor in colon or rectum with significant symptoms related to obstruction or that will require RT

4) History of or current evidence of extrahepatic metastases. (exception: pts with regional nodes that are suspicious in imaging and are associated with primary CRC tumor are eligible if nodes will be resected with the primary tumor after randomization)

5) Radiographic evidence of metastases to portal LN unless proven biopsy negative

6) Previous hepatic-directed therapy including hepatic resection and/or ablation, hepatic arterial infusion therapy, or hepatic RT (only incisional or excisional biopsy are eligible)

7) Previous chemotherapy or systematic therapy for metastatic colorectal cancer

8) Portal vein embolization or other hepatic preconditioning techniques performed or plans for preconditioning techniques

9) Intent to use ablation to treat any hepatic lesion

10) Pre-existing chronic-hepatic disease

11) Grade 3 or 4 anorexia, grade 3 nausea, or grade 2 vomiting related to metastatic disease

 

 

IRB Protocol Number
NSABP C-11

Clinical Trial Categories

  • Cancer
Contact
RN. Annette Barr, RN at 740-588-7816