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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Pancreatic Cancer
- Sponsor
- University of Massachusetts, Worcester
- Locations
- 1
- Primary Endpoint
- To estimate the 3 year progression-free survival of patients with localized, resectable pancreatic cancer
- Status
- Withdrawn
- Last Updated
- 11 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
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
- •Patient must have adequate hematological, renal and hepatic function defined as:
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- To estimate resection rate(1 Year)