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

Stopped early · Not applicable

Conditions studied: Pain, Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT00660348

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

1

Starts

2008-03-01

Expected to finish

2011-03-01

Last updated by the study team

2014-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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