Overview

Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gary Morrow
Collaborator:
National Cancer Institute (NCI)
Treatments:
Naproxen
Criteria
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