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

NCT01494155 | Unknown Phase 2 DMC

• 1 other identifier: 11-073
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

resectable pancreatic cancer; pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  To determine the progression-free survival of the addition of hydroxychloroquine to preoperative short course, chemoradiation therapy and adjuvant gemcitabine chemotherapy

  2 years

Secondary Outcomes (10)

• Pathologic response rate

  2 years

• Overall survival

  2 years

• Toxicity/Adverse events

  2 years

• Surgical morbidity

  2 years

• Post-operative Mortality

  2 weeks

Study Arms (1)

Hydroxychloroquine

EXPERIMENTAL

Hydroxychloroquine with chemoradiation

Drug: Capecitabine; Drug: Hydroxychloroquine; Radiation: Proton or Photon Radiation Therapy

Interventions

Capecitabine DRUG

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

Also known as: Xeloda

Hydroxychloroquine

Hydroxychloroquine DRUG

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

Also known as: Plaquenil

Hydroxychloroquine

Proton or Photon Radiation Therapy RADIATION

Daily, beginning Week 2 for 5 consecutive days

Hydroxychloroquine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cytologic or histologic proof of pancreatic ductal carcinoma
• Life expectancy \> 3 months
• Adequate organ and marrow function

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine; Hydroxychloroquine; Protons

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Theodore S Hong, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: December 16, 2011
• Study Start: December 1, 2011
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: February 2, 2021

Record last verified: 2021-02

Locations

US (1)