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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Celgene Corporation |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00379353 |
Primary Objectives:
Condition | Intervention | Phase |
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Advanced Cancers |
Drug: Thalidomide Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Effects of Thalidomide on Symptom Clusters |
Estimated Enrollment: | 62 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Thalidomide
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Drug: Thalidomide
100 mg PO Daily x 14 Days
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2: Placebo Comparator
Placebo
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Drug: Placebo
Two placebo capsules orally, once a day for 14 days.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eduardo Bruera, MD | 713-792-6085 |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Eduardo Bruera, MD |
Principal Investigator: | Eduardo Bruera, MD | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Eduardo Bruera, MD/Chair ) |
Study ID Numbers: | 2005-0980 |
Study First Received: | September 19, 2006 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00379353 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Advanced Cancers Anorexia Fatigue Thalidomide Placebo |
Anti-Bacterial Agents Fatigue Immunologic Factors Thalidomide |
Anorexia Angiogenesis Inhibitors Immunosuppressive Agents |
Anti-Infective Agents Thalidomide Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Immunosuppressive Agents |
Angiogenesis Inhibitors Pharmacologic Actions Anti-Bacterial Agents Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Leprostatic Agents |