Hydroxychloroquine in Previously Treated Patients With Metastatic Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Brian Wolpin, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01273805
First received: January 7, 2011
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

Hydroxychloroquine is approved for the treatment of non-cancerous illnesses such as rheumatoid arthritis and systemic lupus erythematous. Researchers in the laboratory have tested tumors from patients with pancreatic cancer and have discovered that they have certain pathways inside the cells that promote growth and survival of the tumor. Hydroxychloroquine may inactivate these pathways and results in the death of pancreatic cancer cells.


Condition Intervention Phase
Pancreatic Cancer
Drug: Hydroxychloroquine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Hydroxychloroquine in Previously Treated Patients With Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess progression-free survivial at two months among patients with metastatic pancreatic cancer receiving single-agent hydroxychloroquine.


Secondary Outcome Measures:
  • Biochemical Response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Biochemical response rate (i.e. decrease in serum CA 19-9 by > 30%) in this patient population


Estimated Enrollment: 35
Study Start Date: December 2010
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydroxychloroquine
Oral medication given twice daily.
Drug: Hydroxychloroquine
Pills taken orally twice a day
Other Name: Plaquenil
Drug: Hydroxychloroquine
Pills taken orally twice per day.
Other Name: Plaquenil

Detailed Description:

Every 4 weeks is considered one cycle. Participants will begin taking hydroxychloroquine orally twice per day starting on Cycle 1 Day 1. They will need to return to the clinic every two weeks for blood tests and to see the doctor or nurse practitioner.

Participants may remain on the study indefinitely as long as it is in their best interest to do so. They will have CT scans every 8 weeks which will help determine if the cancer is growing or staying the same.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed unresectable pancreatic adenocarcinoma that is metastatic to distant sites
  • Measurable disease, defined as at least one lesion that can accurately be measured in at least one dimension
  • Patients must have been treated with one or two previous lines of chemotherapy for metastatic disease with documented tumor progression or intolerance due to toxicity
  • Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
  • 18 years of age or older
  • Life expectancy of greater than 12 weeks
  • ECOG performance status of 0, 1 or 2
  • Normal organ and marrow function as outlined in the protocol
  • Patients must be able to swallow pills
  • Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria:

  • Participants who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • More than two previous chemotherapy regimens for the treatment of metastatic pancreatic cancer
  • Uncontrolled brain or leptomeningeal metastases
  • History of macular degeneration, visual field changes, retinal disease, or cataracts that would interfere with funduscopic eye examinations
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to hydroxychloroquine
  • Previous treatment with chloroquine or hydroxychloroquine for other indications, such as rheumatoid arthritis, SLE or malaria prophylaxis
  • Prior treatment with any investigational drug within the preceding 4 weeks
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter absorption of hydroxychloroquine. Patients who have undergone a Whipple procedure for localized pancreatic cancer are not excluded from enrollment
  • History of non-compliance to medical regimens
  • Known diagnosis of glucose-6-phosphate deficiency, porphyria or psoriasis
  • Penicillamine use for Wilson's disease or any other indication
  • Uncontrolled intercurrent illness including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or breastfeeding women
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3-years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past three years: cervical cancer in situ, and basal cell or squamous cell carcinoma
  • HIV-positive individuals on combination antiretroviral therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01273805

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
Principal Investigator: Brian Wolpin, MD, MPH Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Brian Wolpin, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01273805     History of Changes
Other Study ID Numbers: 10-310
Study First Received: January 7, 2011
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
metastatic pancreatic cancer
hydroxychloroquine

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 21, 2014