Standard Pain Control or Intrathecal Therapy in Controlling Pain in Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
Pain, Pancreatic Cancer
About this trial
This is an interventional supportive care trial for Pain focused on measuring recurrent pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer, adenocarcinoma of the pancreas, pain, stage II pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically confirmed adenocarcinoma of the pancreas
- Mixed adenocarcinoma tumors allowed provided the predominant invasive component of the tumor is adenocarcinoma
- Locally advanced, unresectable, or metastatic disease
- Patients must be within two months of diagnosis or have started chemotherapy within 60 days of study
- Average pain score ≥ 4/10 over a 7-day period on a verbal numerical rating scale
Exclusion criteria:
- Known brain metastases
- Tumor with clinically significant obstruction of the spinal canal
PATIENT CHARACTERISTICS:
Inclusion criteria:
- Karnofsky performance status 60-100%
- ANC ≥ 1,500 cells/mm³
- Hematocrit ≥ 28%
- WBC ≥ 3,500 cells/mm³
- Platelets ≥ 90,000/mm³
- Serum creatinine ≤ 2.0 mg/dL
- Bilirubin ≤ 2.5 mg/dL
- AST/ALT ≤ 5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 5 times ULN
- INR ≤ 1.5
- Not pregnant or nursing
- Negative pregnancy test
- Mini-mental status exam score ≥ 22
Exclusion criteria:
Uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this therapy, including any of the following:
- Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
- Active peptic ulcer disease
- Active infections
- Insensitive to opioid medication for cancer pain
- Insufficient tissue or decubitus ulcer near device implantation site
- Current history of substance abuse
PRIOR CONCURRENT THERAPY:
- Minor procedures (i.e., dental work or skin biopsy), tumor biopsies, and biliary stent placement are allowed
- No prior surgical procedures affecting absorption
- Prior or other concurrent pain medications are allowed
- Concurrent chemotherapy or radiotherapy allowed at the discretion of the treating physician
Sites / Locations
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
morphine
Intrathecal pump
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