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

NCT ID: NCT01494155

Last Updated: 2021-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2023-01-31

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).

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hydroxychloroquine

Hydroxychloroquine with chemoradiation

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

825 mg/m2 BID orally for a total of 10 days (M-F of weeks 2 and 3)

Hydroxychloroquine

Intervention Type: DRUG

400 mg BID from study day 1 until surgery. Dosing resumed upon discharge from hospital

Proton or Photon Radiation Therapy

Intervention Type: RADIATION

Daily, beginning Week 2 for 5 consecutive days

Interventions

Capecitabine

825 mg/m2 BID orally for a total of 10 days (M-F of weeks 2 and 3)

Intervention Type: DRUG

Hydroxychloroquine

400 mg BID from study day 1 until surgery. Dosing resumed upon discharge from hospital

Intervention Type: DRUG

Proton or Photon Radiation Therapy

Daily, beginning Week 2 for 5 consecutive days

Intervention Type: RADIATION

Other Intervention Names

Xeloda; Plaquenil

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Theodore Sunki Hong

Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theodore S Hong, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

11-073

Identifier Type: -

Identifier Source: org_study_id