Hydroxychloroquine in Previously Treated Patients With Metastatic Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

Primary Objective * To determine the efficacy of single-agent hydroxychloroquine in patients with metastatic pancreatic cancer previously treated with one or two prior chemotherapy regimens as measured by progression-free survival at two months Secondary Objectives * To assess tumor response rate, biochemical response rate (i.e. decrease in serum CA19-9 by \> 30%), and overall survival Translational/Exploratory Objectives * To investigate predictors of response to anti-autophagy therapy with hydroxychloroquine * To explore the kinetics of in vivo autophagy inhibition using peripheral blood WBCs to monitor autophagic activity among patients receiving hydroxychloroquine

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

2-month Progression-Free Survival Rate [Disease was evaluated radiologically at baseline and at the first restaging at 2 months.]. Number, percentage of patients (95% Confidence Interval). Hydroxychloroquine 400 mg b.i.d. (n=10): 10 (.28 to 44.5); Hydroxychloroquine 600 mg b.i.d. (n=10): 10 (.28 to 44.5).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Biochemical Response Rate [Disease was evaluated radiologically at baseline and every 2 months on treatment. Median duration of treatment for this study cohort was 34 days.].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Tumor Response Rate [Disease was evaluated radiologically at baseline and every 2 months on treatment. Median duration of treatment for this study cohort was 34 days.]. Number, percentage of patients. Hydroxychloroquine 400 mg b.i.d. (n=10): 0; Hydroxychloroquine 600 mg b.i.d. (n=10): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival [All patients were followed until death. Median survival follow-up in this study cohort was 60 days (95% CI: 40-184).]. Median, days (95% Confidence Interval). Hydroxychloroquine 400 mg b.i.d. (n=10): 51.5 (24 to 275); Hydroxychloroquine 600 mg b.i.d. (n=10): 83 (40 to 178).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression-Free Survival [Disease was evaluated radiologically at baseline and every 2 months on treatment. Median PFS follow-up in this study cohort was 46.5 days (95% CI 33-61).]. Median, days (95% Confidence Interval). Hydroxychloroquine 400 mg b.i.d. (n=10): 51.5 (16 to 66); Hydroxychloroquine 600 mg b.i.d. (n=10): 44.5 (33 to 74).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Grade 4-5 Treatment-Related Toxicity [Adverse events were assessed each cycle throughout treatment. Participants were followed for the duration of treatment, an average of 34 days for this study population.]. Count Of Participants, Participants. Hydroxychloroquine 400 mg b.i.d. (n=10): 0; Hydroxychloroquine 600 mg b.i.d. (n=10): 0.