Clinical trial NCT00602420: Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
Official title: Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Musculoskeletal Complications
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: pain
musculoskeletal complications
unspecified adult solid tumor, protocol specific
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-01-28
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule.
timeFrame: From baseline through day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: MBCCOP - Hawaii
state: Hawaii
city: Decatur
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: Evanston
country: United States
facility: CCOP - Evanston
state: Illinois
city: Wichita
country: United States
facility: CCOP - Wichita
state: Kansas
city: Grand Rapids
country: United States
facility: CCOP - Grand Rapids
state: Michigan
city: St. Louis Park
country: United States
facility: CCOP - Metro-Minnesota
state: Minnesota
city: Kansas City
country: United States
facility: CCOP - Kansas City
state: Missouri
city: Syracuse
country: United States
facility: CCOP - Hematology-Oncology Associates of Central New York
state: New York
city: Goldsboro
country: United States
facility: CCOP - Southeast Cancer Control Consortium
state: North Carolina
city: Columbus
country: United States
facility: CCOP - Columbus
state: Ohio
city: Dayton
country: United States
facility: CCOP - Dayton
state: Ohio
city: Greenville
country: United States
facility: CCOP - Greenville
state: South Carolina
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
city: Seattle
country: United States
facility: CCOP - Virginia Mason Research Center
state: Washington
city: Tacoma
country: United States
facility: CCOP - Northwest
state: Washington
city: Marshfield
country: United States
facility: CCOP - Marshfield Clinic Research Foundation
state: Wisconsin
Study officials:
affiliation: CCOP - Hematology-Oncology Associates of Central New York
name: Jeffrey J. Kirshner, MD
role: STUDY_CHAIR
affiliation: University of Rochester
name: Gary R. Morrow, PhD, MS
role: STUDY_CHAIR
affiliation: CCOP - Greenville
name: Jeffrey K. Giguere, MD, FACP
role: STUDY_CHAIR
References: