Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

Phase 3

Completed

• Conditions: Musculoskeletal Complications; Pain; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Drug: naproxen; Other: placebo

• Registration Number: NCT00602420
• Lead Sponsor: Gary Morrow

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-01-28
• Study Start: 2008-06
• Primary Completion: 2012-01
• Study Completion: 2012-03
• Results First Submitted: 2014-06-24
• Results First Submitted QC: 2015-05-08
• Results First Posted: 2015-05-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 510

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naproxen	naproxen	Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
Placebo	placebo	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.

Primary Outcome Measures

Name	Time	Method
Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule.	From baseline through day 5	Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary. Patients recorded daily pain (Pain Scale Score) severity on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) for the last 24 hours. The AUC range was 0-40, and the units are (Pain Scale Score)\*Days.

Trial Locations

Locations (16)

CCOP - Virginia Mason Research Center; 🇺🇸 Seattle, Washington, United States

CCOP - Central Illinois; 🇺🇸 Decatur, Illinois, United States

CCOP - Evanston; 🇺🇸 Evanston, Illinois, United States

CCOP - Hematology-Oncology Associates of Central New York; 🇺🇸 Syracuse, New York, United States

CCOP - Columbus; 🇺🇸 Columbus, Ohio, United States

CCOP - Marshfield Clinic Research Foundation; 🇺🇸 Marshfield, Wisconsin, United States

MBCCOP - Hawaii; 🇺🇸 Honolulu, Hawaii, United States

CCOP - Southeast Cancer Control Consortium; 🇺🇸 Goldsboro, North Carolina, United States

CCOP - Upstate Carolina; 🇺🇸 Spartanburg, South Carolina, United States

CCOP - Metro-Minnesota; 🇺🇸 St. Louis Park, Minnesota, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

CCOP - Grand Rapids; 🇺🇸 Grand Rapids, Michigan, United States

CCOP - Dayton; 🇺🇸 Dayton, Ohio, United States

CCOP - Greenville; 🇺🇸 Greenville, South Carolina, United States

CCOP - Northwest; 🇺🇸 Tacoma, Washington, United States

CCOP - Kansas City; 🇺🇸 Kansas City, Missouri, United States