Status:
UNKNOWN
Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 standa...
Detailed Description
Subjects will be treated in cycles of 28 days. Hydroxychloroquine will be taken orally, daily until the day before surgery and will resume after surgery until study end. Capecitabine will be taken or...
Eligibility Criteria
Inclusion
- Cytologic or histologic proof of pancreatic ductal carcinoma
- Life expectancy \> 3 months
- Adequate organ and marrow function
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01494155
Start Date
December 1 2011
End Date
January 1 2023
Last Update
February 2 2021
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114