Hydroxychloroquine in Previously Treated Patients With Metastatic Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Hydroxychloroquine
Intervention MeSH terms: Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: There were 2 arms in this study because the study was amended to evaluate a second cohort of patients treated at a higher dose using the same two-stage statistical design.
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic pancreatic cancer; hydroxychloroquine

Summary:

      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.
    

Eligibility 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