NCT01130701

A Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, . . .

A Phase II Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, Panitumumab and External Beam Radiation, in Patients With Localized, Non-Metastatic Pancreatic Adenocarcinoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, a new chemotherapeutic agent, panitumumab, will be tested in combination with another chemotherapeutic drug, capecitabine, along with external radiotherapy, to find out whether this combination is effective and safe to use before surgery.

Detailed description

Surgical resection remains the standard procedure for patients with localized resectable pancreatic cancer. Neoadjuvant or preoperative therapy with chemotherapy and radiation therapy has been proposed as an alternative approach in patients with localized pancreatic adenocarcinoma. Advantages are: 1) early start of systemic therapy targeting micrometastatic disease; 2) increased compliance with chemoradiotherapy; 3) increase primary tumor complete resection rates; 4) avoidance of surgery in patients with rapidly developing metastatic disease; and 5) importantly, it provides an important resource for research in terms of tissue acquisition before and after therapy . Finally, this is an opportunity to test the safety and efficacy of a novel combination of weekly panitumumab, oral capecitabine and radiation in pancreatic cancer.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
OTHER	Neoadjuvant capecitabine, panitumumab and radiation	Patients will receive six weekly doses of panitumumab (2.5mg/kg) in conjunction oral capecitabine 825 mg/m2 PO bid Mon-Friday and external beam radiation therapy. Panitumumab and oral capecitabine will begin on the first week of external beam radiotherapy and will continue throughout the course of external beam radiation therapy, and will be discontinued following the conclusion of external beam radiation therapy. Patients will be reevaluated for surgical resection 4-6 weeks after completion of neoadjuvant therapy. After surgical resection, adjuvant systemic chemotherapy with gemcitabine for six months is strongly recommended for all patients.

Timeline

• Start date: 2010-05-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2010-05-26
• Last updated: 2015-03-17

Locations

1 site across 1 country: United States