Official Title: “Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial”

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.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Double-Blind, Placebo Control

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.

Primary:

• Severity and duration of bone pain from baseline through day 5 (day 1 being the day pegfilgrastim is administered) as measured by a daily diary No

Secondary:

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

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

Lead Sponsor: University of Rochester

CCOP - Hematology-Oncology Associates of Central New York

Syracuse New York 13215 United States

University of Rochester Cancer Center CCOP Research Base

Rochester New York 14642 United States

CCOP - Greenville

Greenville South Carolina 29615 United States

Overall Clinical Trial Officials and Contacts

Jeffrey J. Kirshner, MD Study Chair CCOP - Hematology-Oncology Associates of Central New York  

Information obtained from ClinicalTrials.gov on July 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00602420

Study ID Number: CDR0000584341

ClinicalTrials.gov Identifier: NCT00602420

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database