Clinical trial NCT01494155: Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: resectable pancreatic cancer
pancreaticoduodenectomy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2011-12-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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).

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

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Pathologic response rate
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
measure: Toxicity/Adverse events
timeFrame: 2 years
measure: Surgical morbidity
timeFrame: 2 years
measure: Post-operative Mortality
timeFrame: 2 weeks
measure: Biomarkers
timeFrame: 2 years
measure: Pathologic down-staging
timeFrame: 2 years
measure: Local control
timeFrame: 2 years
measure: Describe QoL
timeFrame: 2 Years
measure: Measure utilization of health services
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Theodore S Hong, MD
role: PRINCIPAL_INVESTIGATOR
References: