• Potential risk factors for the development of pegfilgrastim-induced bone pain [ Designated as safety issue: No ]
• Potential clinical predictors for response or failure to respond to treatment [ Designated as safety issue: No ]
• Presence or severity of symptoms prior to study enrollment and at study outcome as measured by the Symptom Inventory [ Designated as safety issue: No ]
• Toxicity [ Designated as safety issue: Yes ]

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.

OBJECTIVES:

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 CCOP site. Patients are randomized to 1 of 2 treatment arms.

• 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 an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.

Patients complete questionnaires, including the Symptom Inventory and Brief Pain Inventory, at baseline and after completion of study treatment. Patients also complete a daily pain diary during study treatment.

• Musculoskeletal Complications
• Pain
• Unspecified Adult Solid Tumor, Protocol Specific

• Drug: naproxen
• Other: placebo

• Experimental: Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
• Placebo Comparator: 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.

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• Not pregnant or nursing
• Creatinine ≤ 1.5 times upper limit of normal
• Able to understand English
• No clinical evidence of active gastrointestinal bleeding, prior gastrointestinal bleeding, or gastric or duodenal ulcers
• No known allergy to naproxen
• No prior development of the triad of asthma, rhinitis, and nasal polyps after taking acetylsalicylic acid (aspirin) or other NSAIDs

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 6 months since prior surgery on the heart
• No 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
• No concurrent steroids on a regular basis

• No concurrent prescription or non-prescription medications for preexisting chronic pain

  • Concurrent cardioprotective doses (≤ 325 mg/day) of aspirin allowed
• No concurrent therapeutic doses of warfarin