Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

Completed · Phase 3 · Has a placebo group

Conditions studied: Musculoskeletal Complications, Pain, Unspecified Adult Solid Tumor, Protocol Specific

In brief

RATIONALE: Naproxen may help prevent or lessen bone pain caused by pegfilgrastim. It is not yet known whether naproxen is more effective than a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy. 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.

Key facts

Study ID

NCT00602420

Run by

Gary Morrow

People needed

510

Starts

2008-06-01

Expected to finish

2012-03-01

Last updated by the study team

2015-11-09

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of a non-hematologic (non-myeloid) malignancy
• 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

You may not qualify if…

• Pregnant or nursing
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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