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Phase II Study of Hydroxychloroquine in Previously Treated Patients With Metastatic Pancreatic Cancer

Phase 2
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Phase II Study of Hydroxychloroquine in Previously Treated Patients With Metastatic Pancreatic Cancer

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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival

Outcome Description:

To assess progression-free survivial at two months among patients with metastatic pancreatic cancer receiving single-agent hydroxychloroquine.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Brian Wolpin, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

December 2010

Completion Date:

May 2013

Related Keywords:

  • Pancreatic Cancer
  • metastatic pancreatic cancer
  • hydroxychloroquine
  • Pancreatic Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617