Treatment for Chronic Pain in Patients With Advanced Cancer
Condition: 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
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Neoplasms, Plasma Cell; Preleukemia; Plasmacytoma; Intestinal Neoplasms; Precancerous Conditions; Myelodysplastic Syndromes; Myeloproliferative Disorders; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

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.
    

Intervention name(s): dextromethorphan hydrobromide; morphine sulfate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Morphine; Dextromethorphan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: 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; essential thrombocythemia; untreated hairy cell leukemia; progressive hairy cell leukemia, initial treatment; refractory hairy cell leukemia; chronic myelomonocytic leukemia; T-cell large granular lymphocyte leukemia; acute undifferentiated leukemia; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage III adult lymphoblastic lymphoma; stage III adult Burkitt lymphoma; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult lymphoblastic lymphoma; stage IV adult Burkitt lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent adult Burkitt lymphoma; stage III adult T-cell leukemia/lymphoma; stage IV adult T-cell leukemia/lymphoma; recurrent adult T-cell leukemia/lymphoma; secondary acute myeloid leukemia; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; pain; prolymphocytic leukemia; AIDS-related peripheral/systemic lymphoma; AIDS-related primary CNS lymphoma; primary systemic amyloidosis; non-Hodgkin lymphoma during pregnancy; stage III mantle cell lymphoma; stage IV mantle cell lymphoma; recurrent mantle cell lymphoma; angioimmunoblastic T-cell lymphoma; anaplastic large cell lymphoma; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome; recurrent mycosis fungoides/Sezary syndrome; chronic eosinophilic leukemia; chronic neutrophilic leukemia; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage III marginal zone lymphoma; stage IV small lymphocytic lymphoma; stage IV marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma; childhood myelodysplastic syndromes