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Study never went beyond FDA application for an IND #. FDAA required institutional DSMC which this institution then lacked.
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant capecitabine, panitumumab and radiation | Other | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the 3 year progression-free survival of patients with localized, resectable pancreatic cancer | 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. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate resection rate | 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. |
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Inclusion Criteria:
Cytological or histological confirmation of pancreatic adenocarcinoma is required.
Only patients with localized and apparently resectable, non-metastatic tumors are eligible. All patients must be staged with a chest X-ray or chest CT and abdominal and pelvic CT scan or MRI.
One of the following radiological criteria must be met and recorded in chart by dedicated surgeon prior to enrollment.
A)Localized, potentially resectable : 1) no evidence of tumor extension to the celiac axis, hepatic artery or superior mesenteric artery; 2) no evidence of tumor encasement or occlusion of superior mesenteric vein (SMV) or the SMV/portal vein(PV) confluence; 3) no evidence of visceral or peritoneal metastasis
B)Borderline resectable: 1) no extra pancreatic disease, (2) the following possible tumor-vessel relationships: an SMV-PV confluence that can be reconstructed even if short segment venous occlusion is present; tumor abutment of the SMA of ≤180°; or short segment encasement of the hepatic artery amenable to resection and reconstruction.
Patients with the following radiological criteria are NOT eligible:
A) Locally advanced disease: (1) no extra pancreatic disease, (2) tumor encasement of the SMA or celiac axis defined as tumor involvement of >180° of the arterial circumference. B) Radiographic evidence of distant organ or peritoneal metastases.
Age > 18 years.
ECOG performance status 0 and 1.
Patient must have adequate hematological, renal and hepatic function defined as:
WBC > 2,000 cells/mm3 ANC>1500 cells/mm3 Hemoglobin > 9.0 g/dL Platelets > 100,000 cells/mm3 Serum creatinine < 1.5 x upper limit of normal (UNL) or a calculated creatinine clearance of > 50 mL/min calculated by Cockcroft-Gault method Total bilirubin < 2.5 mg/dl AST < 3x upper limits of normal ALT < 3x upper limits of normal
Serum calcium and magnesium levels within limits of normal
Patients may not have any prior therapy for carcinoma of the pancreas, nor prior abdominal radiation therapy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bilal Piperdi, MD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18506163 | Result | Willett CG, Czito BG. Does adjuvant chemoradiation benefit patients who have undergone resection of pancreatic or periampullary cancer? Nat Clin Pract Gastroenterol Hepatol. 2008 Jul;5(7):364-5. doi: 10.1038/ncpgasthep1152. Epub 2008 May 27. No abstract available. | |
| 18407737 | Result | Meyer JJ, Willett CG, Czito BG. Is there a role for advanced radiation therapy technologies in the treatment of pancreatic adenocarcinoma? Future Oncol. 2008 Apr;4(2):241-55. doi: 10.2217/14796694.4.2.241. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| D011827 | Radiation |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 1 Year |
| 8380315 | Result | Geer RJ, Brennan MF. Prognostic indicators for survival after resection of pancreatic adenocarcinoma. Am J Surg. 1993 Jan;165(1):68-72; discussion 72-3. doi: 10.1016/s0002-9610(05)80406-4. |
| 10918161 | Result | Snady H, Bruckner H, Cooperman A, Paradiso J, Kiefer L. Survival advantage of combined chemoradiotherapy compared with resection as the initial treatment of patients with regional pancreatic carcinoma. An outcomes trial. Cancer. 2000 Jul 15;89(2):314-27. doi: 10.1002/1097-0142(20000715)89:23.0.co;2-v. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D055585 | Physical Phenomena |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |