Patients will receive single agent carfilzomib on a weekly dosing schedule (days 1, 8, 15) in a 21 day cycle. The initial dose will be 20 mg/m² for cycle 1, day 1. Dose escalation will proceed in a standard 3+3 fashion with the requirement that dose escalation to the next level can only proceed if 0 of 3 or ≤ 1 of 6 patients experience a dose limiting toxicity (DLT). Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses.

Neoplasms

Malignancies

Carfilzomib will be given as an IV infusion over 4 hours. Subjects will remain at the clinic under observation for at least 1 hour following each dose of carfilzomib in Cycle 1 and following the dose on Cycle 2 Day 1. During these observation times, post dose IV hydration may be given at physician's discretion.

Carfilzomib

Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses.

Dexamethasone

Emory University Winship Cancer Institute

Extended Infusion Carfilzomib on a Weekly Schedule in Patients With Advanced Solid Tumors

A Phase I Study of Extended Infusion Carfilzomib on a Weekly Schedule in Patients With Advanced Solid Malignancies

Evaluate safety and tolerability of weekly dosed carfilzomib as assessed by using NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.4 criteria to determine DLTs, the MTD, and RP2D

Pharmacokinetic analysis (Tmax, Cmax, t1/2, AUC)

Pharmacodynamic (PD) evaluation of degree of 20S proteasomal inhibition in PBMC assays conducted at Emory University before treatment and at time of first restaging scan

Objective Response Rate (CR + PR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in patients who completed at least 2 cycles of protocol therapy

Clinical Benefit Rate (CR + PR + SD) by RECIST 1.1 criteria in patients who completed at least 2 cycles of protocol therapy

Bradley Carthon MD, PhD

Assistant Professor

Emory University

Amgen

morphine given traditionally (IV, pill, patch). This is standard of care dosing.

Pump internal used to deliver morphine. This is a newer method for delivery of morphine. Morphine is FDA approved for intrathecal use. The intrathecal pump will be titrated gradually to effect by the interventional pain medicine team. These are the maximum doses and concentrations in keeping with the Polyanalgesic Consensus Conference guidelines: Dose (mg/day):15 ; Conc (mg/cc): 20

morphine given traditionally (IV, pill, patch)
morphine sulfate: This is morphine given in the traditional methods.

Morphine

Pump internal used to deliver morphine. This is a newer method for delivery of morphine.
Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine.

Intrathecal Pump

Total

Gender

Race (NIH/OMB)

Ethnicity (NIH/OMB)

Region of Enrollment

The primary objective of this study is to compare the effectiveness of pain control between intrathecal opioid delivery and standard analgesia delivery method in patients with locally advanced unresectable or metastatic pancreatic cancer. The primary end point is the number of subjects on each arm showing a decrease in the change in VAS self-assessment pain intensity rating (VAS pain rating) at one month from initial treatment with respect to the baseline pain score. The change is defined as (the Pain Score at one month of the treatment - the Pain Score at baseline). Serial pain scores will be collected at all assessment time points. Min: zero cm. Max 10cm. A higher value means worse pain. Subjects on each arm will report pain on a 10 cm Visual Analogue Scale (VAS) pain rating scale, by making a mark on the 10cm horizontal line with a pen and study team will measure distance from the mark to the start of the scale, which will indicate pain score (eg 1 cm, 3 cm 6 cm, etc.).

morphine given traditionally (IV, pill, patch). This is standard of care dosing.
morphine sulfate: This is morphine given in the traditional methods.

Pump internal used to deliver morphine. This is a newer method for delivery of morphine. Morphine is FDA approved for intrathecal use. The intrathecal pump will be titrated gradually to effect by the interventional pain medicine team. These are the maximum doses and concentrations in keeping with the Polyanalgesic Consensus Conference guidelines: Dose (mg/day):15 ; Conc (mg/cc): 20
Medtronic intrathecal pump: This pump will be inserted into the research subject and then the pump will deliver morphine.

Number of Subjects Per Arm With Decrease in Pain Scores

Overall Study

Michael Erdek, MD

Pain

Pancreatic Cancer

This is morphine given in the traditional methods.

morphine sulfate

This pump will be inserted into the research subject and then the pump will deliver morphine.

Medtronic intrathecal pump

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Standard Pain Control or Intrathecal Therapy in Controlling Pain in Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

A Randomized Study of Optimal Pain Management: Standard Pain Control Versus Early Intervention With Intrathecal Therapy in Patients With Advanced Pancreatic Cancer

pancreatic neoplasms/headache

Extended Infusion Carfilzomib on a Weekly Schedule in Patients With Advanced Solid Tumors

Standard Pain Control or Intrathecal Therapy in Controlling Pain in Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

Acupuncture For Pancreatic Cancer Pain

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