Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

Gary Morrow

Status and phase

Completed

Phase 3

Conditions

Musculoskeletal Complications

Unspecified Adult Solid Tumor, Protocol Specific

Pain

Treatments

Other: placebo

Drug: naproxen

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00602420

U10CA037420 (U.S. NIH Grant/Contract)

URCC-07079 (Other Identifier)

CDR0000584341

Details and patient eligibility

About

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.

Full description

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.

Enrollment

510 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

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