Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2018 |
| Start Date: | December 2011 |
| End Date: | January 2020 |
Phase II Study of Neoadjuvant Accelerated Short Course Radiation Therapy With Proton or Photon RT Plus Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer
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.
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.
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).
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).
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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Theodore S Hong, MD
Click here to add this to my saved trials
