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

NCT00660348 | Terminated Results

• 4 other identifiers: JHOC-J0724 CDR0000593173P30CA006973JHOC-J0724JHOC_NA_00009208
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Pancreatic Cancer

Keywords

recurrent pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer; adenocarcinoma of the pancreas; pain; stage II pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Per Arm With Decrease in Pain Scores

  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.).

  1 month

Study Arms (2)

morphine

ACTIVE COMPARATOR

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

Drug: morphine sulfate

Intrathecal pump

ACTIVE COMPARATOR

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

Device: Medtronic intrathecal pump

Interventions

morphine sulfate DRUG

This is morphine given in the traditional methods.

morphine

Medtronic intrathecal pump DEVICE

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

Intrathecal pump

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Pain; Pancreatic Neoplasms

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

Subject started study 7/14/2010, but withdrew her consent on 7/24/2010 due to increased upper quadrant pain. One subject enrolled. She withdrew consent before study team could collect any follow-up data. We do not have any participants to analyze.

Results Point of Contact

• Title: Michael Erdek, MD
• Organization: Sidney Kimmel Comprehensive Cancer Center

merdek1@jhmi.edu

410-502-7388

Study Officials

• Michael Erdek, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 17, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: October 8, 2014
• Results First Posted: October 8, 2014

Record last verified: 2014-10

Locations

US (1)