Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

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 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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

James P. Wilmot Cancer Center at University of Rochester Medical Center

Jeffrey J. Kirshner

Study Chair

Gary R. Morrow

Study Chair

Jeffrey Kent Giguere

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00602420
Information obtained from ClinicalTrials.gov on December 14, 2011

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