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| Sponsored by: |
National Cancer Institute of Canada |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003687 |
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 III |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double-Blind, Active Control |
| 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 |
| Study Start Date: | December 1998 |
OBJECTIVES:
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.
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 |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and 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 | |
| Study Chair: | Eduardo Bruera, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000066789, CAN-NCIC-SC17 |
| Study First Received: | November 1, 1999 |
| Last Updated: | November 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003687 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Blast Crisis Neurotransmitter Agents Mantle Cell Lymphoma Ileal Diseases Preleukemia Leukemia, Prolymphocytic Hemorrhagic Disorders Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Thrombocythemia, Hemorrhagic Phenylpropanolamine Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders |
Narcotics Leukemia, Myeloid Waldenstrom Macroglobulinemia Plasmacytoma Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Precancerous Conditions Blood Protein Disorders Lymphoma, Follicular Pain Sezary Syndrome Lymphoblastic Lymphoma Naphazoline Lymphoma, B-Cell |
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Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Excitatory Amino Acid Agents Ileal Diseases Duodenal Neoplasms Preleukemia Hemorrhagic Disorders Pathologic Processes Neoplasms by Site Therapeutic Uses Cardiovascular Diseases Morphine Immunoproliferative Disorders Digestive System Neoplasms |
Immune System Diseases Hematologic Diseases Myeloproliferative Disorders Narcotics Multiple Myeloma Neoplasms Dextromethorphan Gastrointestinal Neoplasms Lymphoma, Non-Hodgkin Antitussive Agents Respiratory System Agents Precancerous Conditions Blood Protein Disorders Gastrointestinal Diseases Paraproteinemias |