Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Inhaled Morphine Compared With Morphine By Mouth in Treating Cancer Patients With Breakthrough Pain

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care Completed 18 and over Pharmaceutical / Industry DFCI-MOR-00-01 ARADIGM-MOR-00-01, BWH-2000-P-001516, NCT00020618

Objectives

I.  Compare the change in pain intensity during the 15 minutes immediately 
following aerosolized vs oral morphine sulfate in cancer patients with 
opioid-sensitive breakthrough pain.

II.  Compare preference for continued use of these regimens in these patients.

III.  Compare the pain relief in patients treated with these regimens.

IV.  Evaluate satisfaction of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

Opioid-sensitive breakthrough pain due to cancer
 More than 1 episode daily
 Oral opiate dose of no more than 100 mg of morphine

No known allergy to morphine or other opioids

No known CNS excitatory response to morphine or other opioids

No unstable persistent morbidity due to prior chemotherapy or radiotherapy

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 Recovered from prior chemotherapy
 No concurrent chemotherapy that would cause toxicity (e.g., emesis)

Endocrine therapy:
 Not specified

Radiotherapy:
 Recovered from prior radiotherapy
 No concurrent radiotherapy that would cause toxicity (e.g., emesis)

Surgery:
 Not specified

Other:
 At least 30 days or 5 half-lives (whichever is longer) since prior
  investigational drug
 No concurrent MAO inhibitors

Patient Characteristics:

Age:
 18 and over

Performance status:
 ECOG 0-3

Life expectancy:
 More than 3 months

Hematopoietic:
 Not specified

Hepatic:
 Bilirubin less than 2.0 mg/dL
 AST less than 82 U/L
 ALT less than 72 U/L

Renal:
 Creatinine less than 1.5 mg/dL

Pulmonary:
 No significant history or recent exacerbation of bronchial asthma
 No chronic obstructive pulmonary disease
 No significant pulmonary pathology that would preclude study

Other:
 No history of substance abuse, including alcohol, within the past 2 months
 No other condition that would preclude study
 Not pregnant or nursing
 Fertile patients must use effective contraception

Expected Enrollment

Approximately 50 patients will be accrued for this study.

Outline

This is a randomized, open-label, crossover, multicenter study.  Patients are 
randomized to 1 of 2 treatment arms.

Patients undergo titration of aerosolized morphine sulfate over days 1-7 to 
determine the optimal baseline and breakthrough dosage.

Arm I:  Patients receive aerosolized morphine sulfate as needed for 
breakthrough pain, up to 4 inhalations every 15 minutes, on days 8-14.  
Patients crossover to oral morphine sulfate as needed for breakthrough pain on 
days 15-21.

Arm II:  Patients receive oral morphine sulfate as needed for breakthrough 
pain on days 8-14.  Patients crossover to aerosolized morphine sulfate as 
needed for breakthrough pain, up to 4 inhalations every 15 minutes, on days 
15-21.

Patients may continue treatment with either oral or aerosolized morphine 
sulfate for an additional 60 days beginning on day 22.

Quality of life is assessed weekly for 3 weeks.  Patients complete a pain 
management satisfaction survey at the end of each therapy crossover week.

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Nathaniel Katz, MD, Protocol chair		Ph: 617-632-3474; 866-790-4500

Registry Information
Official Title		An Open Label, Randomized, Multicenter, Crossover, Phase II Study to Compare Pain Relief Following Morphine Administration via AERxPMS vs Orally in Cancer Patients Experiencing Opioid-Sensitive Breakthrough Pain
Trial Start Date		2001-03-09
Registered in ClinicalTrials.gov		NCT00020618
Date Submitted to PDQ		2001-04-16
Information Last Verified		2002-02-01
NCI Grant/Contract Number		CA06516