Hydroxychloroquine in Previously Treated Patients With Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01273805
• Other study ID #: 10-310
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 7, 2011
• Last updated: February 23, 2017
• Start date: December 2010

Study information

• Verified date: February 2017
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Hydroxychloroquine
Pills taken orally twice a day
• Hydroxychloroquine
Pills taken orally twice per day.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival	To assess progression-free survivial at two months among patients with metastatic pancreatic cancer receiving single-agent hydroxychloroquine.	2 years
Secondary	Biochemical Response rate	Biochemical response rate (i.e. decrease in serum CA 19-9 by > 30%) in this patient population	2 years