Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

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 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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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