Treatment for Chronic Pain in Patients With Advanced Cancer

This study has been completed.
Sponsor:
Information provided by:
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00003687
First received: November 1, 1999
Last updated: November 7, 2010
Last verified: March 2010
  Purpose

RATIONALE: Different drug formulations and combinations of drugs may help patients with chronic pain live more comfortably. It is not yet known which regimen is most effective for chronic pain.

PURPOSE: Randomized phase III trial to compare the effectiveness of different morphine formulations with or without dextromethorphan in treating chronic pain in patients who have advanced cancer.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Pain
Precancerous/Nonmalignant Condition
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: dextromethorphan hydrobromide
Drug: morphine sulfate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: A Phase III Double-Blind Equivalence Study of Two Different Formulations of Slow-Release Morphine Followed by a Randomization Between Dextromethorphan or Placebo Plus Statex SR for Chronic Cancer Pain Relief in Terminally Ill Patients

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Leukemia, Myeloid Chronic Myeloid Leukemia Chronic Myelomonocytic Leukemia Polycythemia Vera Hypereosinophilic Syndrome Multiple Myeloma Acute Myeloid Leukemia, Adult Lymphoma, Small Cleaved-cell, Diffuse Chronic Lymphocytic Leukemia Leukemia, B-cell, Chronic Acute Lymphoblastic Leukemia Acute Myelocytic Leukemia Acute Non Lymphoblastic Leukemia Follicular Lymphoma Lymphoma, Large-cell Myelodysplastic Syndromes Leukemia, T-cell, Chronic Mycosis Fungoides Sezary Syndrome Cutaneous T-cell Lymphoma Lymphoblastic Lymphoma B-cell Lymphomas Burkitt Lymphoma Lymphoma, Large-cell, Immunoblastic Plasmablastic Lymphoma Hodgkin Lymphoma Mantle Cell Lymphoma Waldenstrom Macroglobulinemia Anaplastic Large Cell Lymphoma Chronic Myeloproliferative Disorders Angioimmunoblastic T-cell Lymphoma Angioimmunoblastic Lymphadenopathy With Dysproteinemia Large Granular Lymphocyte Leukemia Lymphosarcoma Essential Thrombocythemia Myelofibrosis Small Intestine Cancer Central Nervous System Lymphoma, Primary Hairy Cell Leukemia AL Amyloidosis Chronic Neutrophilic Leukemia Anaplastic Plasmacytoma Monoclonal Gammopathy of Undetermined Significance
U.S. FDA Resources

Further study details as provided by NCIC Clinical Trials Group:

Study Start Date: December 1998
Study Completion Date: February 2009
Detailed Description:

OBJECTIVES:

  • Compare the analgesic efficacy of two formulations of morphine (Statex SR versus MS-Contin) in patients requiring morphine for the treatment of chronic cancer pain.
  • Compare the effect of these 2 formulations of morphine on the total analgesic consumption, sleep disturbances, sleep and nausea, responses of different types of pain, and toxic effects experienced in the two treatment groups.
  • Compare the effect of coadministration of morphine and dextromethorphan versus morphine and placebo on pain control in the respective patient groups (phase B).
  • Compare the effect of morphine and dextromethorphan or placebo on total analgesic consumption, sleep disturbances, sleep and nausea, responses of different types of pain, and toxic effects on the two treatment groups (phase B).

OUTLINE: This is a randomized, double-blind, parallel-group, multicenter study. Patients are stratified by stabilization dose (less than 120 mg/day vs greater than 120 mg/day of morphine) and institution in phase A, and neuropathic pain (yes vs no) in phase B.

  • Phase A: Patients are randomized to receive oral morphine in one of two formulations (MS Contin or Statex SR) every 12 hours for 7 days.
  • Phase B: Eligible patients from phase A who have taken no more than 2 breakthrough doses of analgesic per day in the previous 2 days are re-randomized to receive dose escalated oral dextromethorphan capsules or placebo every 4 hours, and oral morphine tablets every 12 hours for 14 days.
  • Phase C: All patients fulfilling entry criteria at the end of phase A or any time during phase B may receive compassionate use morphine tablets for up to 90 days.

Patients complete a pain diary twice each day during treatment.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically proven advanced cancer with chronic pain
  • Cancer pain requiring strong opioids having an average pain score of less than 6/10 on the visual analog scale within last 24 hours
  • Pain managed by a stable maintenance dose of MS-Contin formulation of morphine for at least 2 days with no more than 2 breakthrough immediate release morphine doses per 24 hours
  • Pain that is expected to be controlled by a stable and adequate total daily dose of sustained release morphine for the first 7 days of the study

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • Not specified

Life expectancy:

  • At least 2 months

Hematopoietic:

  • Not specified

Hepatic:

  • SGOT or SGPT no greater than 3 times upper limit of normal (ULN)
  • No liver disease

Renal:

  • Creatinine no greater than 2 times ULN
  • No kidney failure

Pulmonary:

  • No clinically significant respiratory depression
  • No severe obstructive airway disease

Other:

  • Fluent in English or French
  • No known hypersensitivity or allergy to study medications or components or other multiple drug allergies
  • Normal cognition defined by the Folstein Mini-Mental State Questionnaire (at least 24/30 correct)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 14 days since prior chemotherapy

Endocrine therapy:

  • Concurrent steroids allowed

Radiotherapy:

  • At least 14 days since prior analgesic radiotherapy

Surgery:

  • Not specified

Other:

  • At least 3 months since prior investigational agents
  • At least 1 month since prior clinical study
  • No concurrent analgesics other than morphine
  • No other concurrent medications containing dextromethorphan
  • Concurrent antidepressant medication allowed
  • Concurrent nonsteroidal antiinflammatory drugs allowed
  • At least 14 days since prior monoamine oxidase (MAO) inhibitors
  • No concurrent MAO inhibitors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003687

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Newfoundland and Labrador
Newfoundland Cancer Treatment and Research Foundation
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Eduardo Bruera, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
MacDonald S, Dudgeon DJ, Bruera E, et al.: A phase III double-blind equivalence study of two different formulations of slow-release morphine followed by a randomization between dextromethorphan or placebo plus Statex SR for chronic cancer pain relief in terminally ill patients. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1521, 2002.

ClinicalTrials.gov Identifier: NCT00003687     History of Changes
Other Study ID Numbers: SC17, CAN-NCIC-SC17, CDR0000066789
Study First Received: November 1, 1999
Last Updated: November 7, 2010
Health Authority: United States: Federal Government

Keywords provided by NCIC Clinical Trials Group:
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
monoclonal gammopathy of undetermined significance
recurrent adult Hodgkin lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
isolated plasmacytoma of bone
extramedullary plasmacytoma
refractory multiple myeloma
Waldenstrom macroglobulinemia
stage III multiple myeloma
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
small intestine lymphoma
unspecified adult solid tumor, protocol specific
chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
meningeal chronic myelogenous leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
polycythemia vera
chronic idiopathic myelofibrosis

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Preleukemia
Plasmacytoma
Myeloproliferative Disorders
Lymphoma
Leukemia
Syndrome
Precancerous Conditions
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Lymphatic Diseases
Disease
Pathologic Processes
Morphine
Dextromethorphan
Analgesics, Opioid
Narcotics

ClinicalTrials.gov processed this record on September 22, 2014