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

• Status: Terminated
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving medications in different ways may change their effectiveness in controlling pain. It is not yet known whether intrathecal therapy is more effective than standard therapy in controlling pain in patients with pancreatic cancer.

PURPOSE: This randomized clinical trial is studying standard pain control to see how well it works compared with intrathecal therapy in controlling pain in patients with locally advanced, unresectable, or metastatic pancreatic cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Morphine

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