Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments capecitabine, hydroxychloroquine, proton or photon radiation therapy
Phase phase 2
Sponsor Massachusetts General Hospital
Start date December 2011
End date December 2016
Trial size 50 participants
Trial identifier NCT01494155, 11-073

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Hydroxychloroquine with chemoradiation
capecitabine Xeloda
825 mg/m2 BID orally for a total of 10 days (M-F of weeks 2 and 3)
hydroxychloroquine Plaquenil
400 mg BID from study day 1 until surgery. Dosing resumed upon discharge from hospital
proton or photon radiation therapy
Daily, beginning Week 2 for 5 consecutive days

Primary Outcomes

Measure
Progression-free survival
time frame: 2 years

Secondary Outcomes

Measure
Pathologic response rate
time frame: 2 years
Overall survival
time frame: 2 years
Toxicity/Adverse events
time frame: 2 years
Surgical morbidity
time frame: 2 years
Post-operative Mortality
time frame: 2 weeks
Biomarkers
time frame: 2 years
Pathologic down-staging
time frame: 2 years
Local control
time frame: 2 years
Describe QoL
time frame: 2 Years
Measure utilization of health services
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton or Photon RT Plus Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer
Principal investigator Theodore S Hong, MD
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 orally, daily. Proton or photon radiation treatment will start on Week 2 and will be delivered daily (5 days in a row, but not weekends or holidays). Radiation treatment will be give on an outpatient basis at the Francis H. Burr Proton Center or the Clark Center for Radiation Oncology at Massachusetts General Hospital. The following tests will be performed weekly: physical exam, routine blood tests, optional blood tests and an eye exam every 3 months while taking hydroxychloroquine. Subjects will have surgery (any time between Weeks 5 to 9) and after surgery resume taking hydroxychloroquine. Subjects will have a follow up visit every 3 months which will include: physical exam, routine blood tests, eye exam, and tumor assessment by chest and abdominal-pelvic CT scan or MRI (every 6 months for the first 2 years and yearly for years 3-5).
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.