Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
510 participants
INTERVENTIONAL
2008-06-30
2012-03-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying naproxen to see how well it works compared with a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.
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Detailed Description
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Primary
* To compare the efficacy of daily administration of naproxen vs placebo in preventing or reducing the severity and duration of pegfilgrastim-induced bone pain (PIBP) in patients with non-hematologic malignancies undergoing chemotherapy.
Secondary
* To identify potential risk factors for the development of PIBP.
* To identify potential clinical predictors for the response or failure to respond to naproxen in preventing PIBP.
* To assess the toxicity of naproxen when administered in the preventive setting.
OUTLINE: This is a multicenter study. Patients are stratified by Clinical Community Oncology Program (CCOP) site. Patients are randomized to 1 treatment arm vs placebo.
* Arm I: Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
* Arm II: Patients receive matching placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Naproxen
Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
naproxen
Oral naproxen twice daily for 5-8 days.
Placebo
Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
placebo
Oral placebo twice daily for 5-8 days.
Interventions
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naproxen
Oral naproxen twice daily for 5-8 days.
placebo
Oral placebo twice daily for 5-8 days.
Eligibility Criteria
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Inclusion Criteria
* Scheduled to receive chemotherapy; chemotherapy may be given for adjuvant, neoadjuvant, curative, or palliative intent
* Scheduled to receive the first dose of pegfilgrastim (Neulasta®) to ameliorate chemotherapy-induced neutropenia
* Creatinine ≤ 1.5 times upper limit of normal
* Able to understand English
* More than 6 months since prior surgery on the heart
Exclusion Criteria
* Clinical evidence of active gastrointestinal bleeding, prior gastrointestinal bleeding, or gastric or duodenal ulcers
* Allergy to naproxen
* Prior development of the triad of asthma, rhinitis, and nasal polyps after taking acetylsalicylic acid (aspirin) or other NSAIDs
* Concurrent nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or any product containing naproxen (e.g., Naprosyn, EC-Naprosyn, Anaprox, Anaprox-DS, Naprosyn suspension, or Aleve), on a regular basis
* Concurrent steroids on a regular basis
* Concurrent prescription or non-prescription medications for preexisting chronic pain; concurrent cardioprotective doses (≤ 325 mg/day) of aspirin allowed
* Concurrent therapeutic doses of warfarin
18 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gary Morrow
OTHER
Responsible Party
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Gary Morrow
Director, URCC / University of Rochester NCORP Research Base
Principal Investigators
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Jeffrey J. Kirshner, MD
Role: STUDY_CHAIR
CCOP - Hematology-Oncology Associates of Central New York
Gary R. Morrow, PhD, MS
Role: STUDY_CHAIR
University of Rochester
Jeffrey K. Giguere, MD, FACP
Role: STUDY_CHAIR
CCOP - Greenville
Locations
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MBCCOP - Hawaii
Honolulu, Hawaii, United States
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States
CCOP - Columbus
Columbus, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Countries
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Other Identifiers
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URCC-07079
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000584341
Identifier Type: -
Identifier Source: org_study_id
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