Status:
COMPLETED
A Study of Hydroxychloroquine in Combination With Gemcitabine/Abraxane in Pancreatic Cancer
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Advanced Adenocarcinoma
Metastatic Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
In this Phase I/II clinical trial, the investigators seek to pilot the addition of Hydroxychloroquine (HCQ) to a commonly-used front-line therapy of pancreatic cancer, gemcitabine/nab-paclitaxel. The ...
Detailed Description
Recent strategies have focused on improving the efficacy of gemcitabine either by improving the method of delivery, or by combining gemcitabine with other non-cross resistant agents. A sequence of Pha...
Eligibility Criteria
Inclusion
- Patients must have histologically or cytologically documented advanced or metastatic adenocarcinoma of the pancreas.
- Patients must have measurable disease as defined by the RECIST criteria as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 20mm with conventional techniques on either CT or MRI. Marker (CA19-9 or CEA) elevation alone is insufficient for entry.
- Patients may have had prior adjuvant treatment for pancreatic cancer. The last dose of chemotherapy must have been 4 months prior to study entry.
- Patients with prior radiotherapy are acceptable. It must be at least 4 months since administration of radiation therapy and all signs of toxicity must have abated.
- Patients must be age 18 years or older.
- Patients must have an ECOG performance status of 0-1.
- The following required Initial Laboratory Values should be obtained within 4 weeks of the start of treatment:
- Granulocytes 1,500/ml
- Platelet Count 100,000/ml
- Creatinine 1.5 x upper limit of normal
- Bilirubin 1.5 x upper limit of normal
- AST 5 x upper limit of normal
- Patients must not be pregnant or lactating as chemotherapy is thought to present substantial risk to the fetus/infant.
- Patients must have an accessible primary tumor or metastasis, and be willing to have a pre-treatment and post-treatment tumor biopsy (at 6 to 8 weeks after beginning).
- Patients must have a life expectancy of greater than three months.
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients may not be receiving any other investigational agents
- Known allergy to HCQ
- Patients with previous treatment with abraxane.
- Patients on therapeutic doses of Coumadin ( 1 mg daily). The use of therapeutic or prophylactic low molecular weight heparin or fragmin is permitted.
- Patients with known G6PD deficiency, severe psoriasis, porphyria, macular degeneration or severe diabetic retinopathy are ineligible because of the potential for greater HCQ toxicity.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT01506973
Start Date
December 1 2011
End Date
March 1 2022
Last Update
July 25 2025
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104