Phase II Study of Zaltrap and Chemotherapy for Advanced Resectable Colorectal Cancer

Adenocarcinoma of the Rectum Clinical Trial

Official title: Phase II Study of Preoperative Chemotherapy With Ziv-aflibercept (Zaltrap) Followed by Postoperative Chemotherapy With or Without Ziv-aflibercept (Zaltrap) in Patients With Advanced Resectable Colorectal Cancer

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to establish the safety of Zaltrap in patients who undergo pre-operative chemotherapy with Zaltrap. The investigators hypothesize that Zaltrap my impact colorectal cancer growth and metastasis.

Clinical Trial Description

Eligible patients will receive 3 months of chemotherapy consisting of either FOLFOX or FOLFIRI (in the case of liver limited CRC) or FOLFOX (in the case of rectal cancer). The FOLFOX regimen consists of Oxaliplatin, Leucovorin, and 5-FU. The FOLFIRI regimen consists of Irinotecan, Leucovorin, and 5-FU. Zaltrap will be administered with chemotherapy every 2 weeks for the first 5 out of 6 planned treatment cycles. After a standard 3-4 week recovery period (i.e. 5-6 week's from the last Zaltrap dose), patients will undergo standard resection. At the time of resection, the tumor will be collected for biomarker discovery.

Following resection, patients will be randomly assigned (1:1) to receive chemotherapy with or without zaltrap for 3 additional months. Patients assigned to Zaltrap may continue zaltrap (without chemotherapy) until disease recurrence or up to an additional 15 months. Patients will have research blood draws periodically both in the preoperative and postoperative period.

The investigators plan to demonstrate that pre-operative chemotherapy with Zaltrap is not associated with any safety signals that would preclude further drug development in this patient population. The investigators also plan to perform correlative studies to identify potential biomarkers for Zaltrap activity.

The investigators hypothesize that antiangiogenic therapy may specifically target the micrometastatis niche of patients with liver limited metastatic colorectal cancer to significantly increase the chance of cure for these patients. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Colon
• Adenocarcinoma of the Rectum
• Colorectal Neoplasms
• Rectal Neoplasms

• NCT number: NCT02046538
• Study type: Interventional
• Source: Weill Medical College of Cornell University
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2014
• Completion date: February 2018