A Pilot Study to Evaluate the Efficacy and Safety of Neoadjuvant Chemoradiotherapy With Capecitabine, . . . (PMABIIS)
|ClinicalTrials.gov Identifier: NCT01130701|
Recruitment Status : Withdrawn (Study never went beyond FDA application for an IND #. FDAA required institutional DSMC which this institution then lacked.)
First Posted : May 26, 2010
Last Update Posted : March 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Other: Neoadjuvant capecitabine, panitumumab and radiation||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Other: Neoadjuvant capecitabine, panitumumab and radiation
- Vectibix; NSC # 742319
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.
- To estimate the 3 year progression-free survival of patients with localized, resectable pancreatic cancer [ Time Frame: 2 Years ]To estimate the proportions of patients (with localized, resectable and borderline resectable, non-metastatic pancreatic adenocarcinoma) treated with the study regimen alive at 2-years from the date of registration.
- To estimate resection rate [ Time Frame: 1 Year ]To determine the fraction of patients that proceed to planned surgery with the removal of primary tumor (R0/R1) following neoadjuvant therapy; estimate the overall survival in this patient population; evaluate the rate of R0, R1 and R2 resection (defined as per 6th edition of AJCC Cancer Staging Manual) in patients treated with neoadjuvant therapy; the overall response rate to chemoradiation therapy; the biomarker response to chemoradiation through evaluation of circulating CA19-9 levels; to evaluate the toxicity associated with this regimen.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130701
|United States, Massachusetts|
|University of Massachusetts Medical School|
|Worcester, Massachusetts, United States, 01655|
|Principal Investigator:||Bilal Piperdi, MD||University of Massachusetts, Worcester|