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

NCT01130701 | Withdrawn Phase 2

• 1 other identifier: UM2010-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Neoadjuvant; Panitumumab; Capecitabine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To estimate resection rate

  1 Year

Interventions

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.

Also known as: Xeloda, Vectibix; NSC # 742319

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with any other malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• Psychiatric illness which would prevent the patient from giving informed consent.
• Serious medical illness which would limit anticipated survival to \< 12 weeks.
• Protocol treatment would pose significant risk to an unborn child. Pregnant women should not be enrolled, and women of child-bearing age should be strongly encouraged to practice effective birth control during and for six months after the trial. Non-pregnant and non-breast-feeding. Female participants of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Perimenopausal participants must be amenorrheic \> 12 months to be considered not of childbearing potential. All patients (men and women) of reproductive potential must agree to use an effective method of birth-control while receiving study therapy and for six months after completion of therapy.
• Inability to swallow medication. Patients should have adequate, unassisted oral intake.
• Inability to hold still and cooperate during radiotherapy.
• Prior history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or any evidence of interstitial lung disease on baseline chest CT scan.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (4)

• 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.

  PMID: 18506163 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.

  PMID: 18407737 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.

  PMID: 8380315 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.

  PMID: 10918161 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Panitumumab; Radiation; Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Physical Phenomena; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bilal Piperdi, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: May 26, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 17, 2015

Record last verified: 2011-08

Locations

US (1)