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

This study has been terminated.
(Low enrollment)
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00660348
First received: April 16, 2008
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Pain
Pancreatic Cancer
Drug: morphine sulfate
Device: Medtronic intrathecal pump

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Study of Optimal Pain Management: Standard Pain Control Versus Early Intervention With Intrathecal Therapy in Patients With Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Pain as verbally reported by the patient on a 0-10 verbal scale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Will perform pain assessments at baseline and at follow-up visits. Follow-up visits are approximately every two weeks for the first month, monthly for the next two months and every three months thereafter. The final visit will be at 12 months.


Secondary Outcome Measures:
  • Clinical benefit response as measured by change in analgesic consumption (PME), Karnofsky performance status, and quality-of-life scores (EORTC QLQ-C30) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Will perform QOL assessments at baseline and then at follow-up visits. Follow-up visits are approximately every two weeks for the first month, monthly for the next two months and every three months thereafter. The final visit will be at 12 months.

  • Side effects (i.e., nausea, sedation, pruritus, constipation, respiratory depression, and urinary retention) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Side effects will be assessed at follow-up visits. Follow-up visits are approximately every two weeks for the first month, monthly for the next two months and every three months thereafter. The final visit will be at 12 months.

  • Patient survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    patient survival will be tracked for up to 12 months.

  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Will perform safety assessments at follow-up visits. Follow-up visits are approximately every two weeks for the first month, monthly for the next two months and every three months thereafter. The final visit will be at 12 months.


Estimated Enrollment: 80
Study Start Date: March 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: morphine
morphine given traditionally (IV, pill, patch)
Drug: morphine sulfate
This is morphine given in the traditional methods.
Active Comparator: Intrathecal pump
Pump internal used to deliver morphine. This is a newer method for delivery of morphine.
Device: Medtronic intrathecal pump
This pump will be inserted into the research subject and then the pump will deliver morphine.

Detailed Description:

OBJECTIVES:

Primary

  • To compare the effectiveness of pain control comprising intrathecal opioid delivery versus the standard analgesia-delivery method in patients with locally advanced, unresectable, or metastatic pancreatic cancer.

Secondary

  • To assess the difference of a total amount of opioid consumption (parenteral morphine equivalent) between two different opioids-delivery groups at one month of treatment.
  • To assess the average of percent change in Karnofsky performance status with respect to the baseline status between two different analgesic-delivery groups at one month of treatment.
  • To assess the difference in quality of life between two different opioids-delivery groups at one month of treatment using the EORTC QLQ-C30.
  • To assess overall survival of these patients.
  • To assess the safety profile of two different analgesic-delivery methods (i.e., adverse event and serious adverse event).

OUTLINE: Patients are stratified according to Karnofsky performance status (60-80% vs > 80%). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (standard pain management): Patients are evaluated by the JHH Pain Medicine Integrated Team for pain, for the potential of diagnostic/neurolytic celiac plexus block, and undergo the institution of or modification of or continuation and titration of oral or parenteral analgesics. Patients undergo a limited, problem-oriented physical exam including weight, vital signs, Karnofsky performance status (KPS), assessment of previously abnormal findings or new complaints, pain scores, analgesia consumption, side effects (i.e., sleepiness, nausea, pruritus, and constipation), and quality-of-life score (EORTC QLQ-C30) once every 2 weeks for 3 months and then once a month thereafter. Patients also keep a diary of pain scores and side effects during the trial. Patients may have their treatment titrated as needed to control their pain. Patients who are not adequately pain controlled or develop debilitating side effects from their therapy may be managed by adjuvant analgesics or be allowed to crossover into the treatment arm of the study to provide compassionate care.
  • Arm II (intrathecal therapy): Patients undergo implantation of a Medtronic intrathecal pump and catheter system for delivery of morphine sulfate directly into the spinal fluid. Following implantation, patients undergo a limited, problem-oriented physical exam including vital signs, KPS, assessment of previously abnormal findings or new complaints, pain scores, analgesia consumption, and quality-of life-score (EORTC QLQ-C30) once every 2 weeks for 3 months and then once a month thereafter. Patients are also evaluated by the Interventional Pain Treatment Team for wound status, presence of symptoms of post-dural puncture headache, signs of infection, or meningitis. Patients are followed by the JHH Pain Medicine Integrated Team for evaluation of pain and for institution of or modification of or continuation and titration of oral or parenteral analgesics.

After completion of study treatment, patients are followed for 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00660348

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Michael Erdek, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Michael Erdek, SKCCC
ClinicalTrials.gov Identifier: NCT00660348     History of Changes
Other Study ID Numbers: JHOC-J0724 CDR0000593173, P30CA006973, JHOC-J0724, JHOC_NA_00009208
Study First Received: April 16, 2008
Last Updated: July 19, 2011
Health Authority: United States: Federal Government

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
recurrent pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
adenocarcinoma of the pancreas
pain
stage II pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 17, 2014