Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer

Status: Recruiting
Phase: Phase 2
Diagnosis: Radiation Oncology
NCT ID: NCT01494155 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 11-073

 

A standard treatment for patients with pancreatic cancer is standard photon radiation in combination with the chemotherapy drug, capecitabine. In this research study the investigators are using standard photon radiation or a different type of radiation therapy called proton beam radiation and adding hydroxychloroquine to be used in combination with capecitabine. In this research study, the investigators are looking to determine if proton or photon beam radiation in combination with hydroxychloroquine and capecitabine is effective in controlling your cancer growth.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
Theodore Hong, MD, Massachusetts General Hospital

Site-responsible Investigators:
Alec Kimmelman, MD, Dana Faber Cancer Institute

Contacts:
Brigham and Women's Hospital: Kristin Roper, 617-525-7387, kroper@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Cytologic or histologic proof of pancreatic ductal carcinoma - Life expectancy > 3 months - Adequate organ and marrow function Exclusion Criteria: - Evidence of metastatic disease - Pregnant or breast-feeding - Tumors in the body or tail of the pancreas - Serious concomitant systemic disorders such as significant cardiac or pulmonary morbidity (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months, ongoing infection as manifest by fever - Prior chemotherapy or radiation for treatment of the patient's pancreatic tumor - Diagnosis of other invasive carcinomas (except basal cell carcinomas/squamous cell carcinoma of the skin) with the last 5 years. Carcinoma in-situ is allowed. - Other serious uncontrolled medical conditions - Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome - Known, existing uncontrolled coagulopathy - Prior systemic fluoropyrimidine therapy (unless given in an adjuvant setting and completed at least 6 months earlier). Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hypersensitivity to 5-fluorouracil or known DPD deficiency - Participation in any investigational drug study within 4 weeks preceding the start of study treatment - History of uncontrolled seizures, central nervous system disorders, or psychiatric disability - Major surgery, excluding laparoscopy, within 4 weeks of the start of study treatment, without complete recovery - Currently taking cimetidine - Receiving any other study agents - History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine and HCQ - Already taking HCQ or chloroquine for other diagnosis - History of Grade 3 or greater retinopathy or keratitis
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