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Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

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ClinicalTrials.gov Identifier: NCT00602420
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : May 12, 2015
Last Update Posted : November 9, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gary Morrow, University of Rochester NCORP Research Base

Study Description
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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.


Condition or disease Intervention/treatment Phase
Musculoskeletal Complications Pain Unspecified Adult Solid Tumor, Protocol Specific Drug: naproxen Other: placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial
Study Start Date : June 2008
Actual Primary Completion Date : January 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: naproxen
Oral naproxen twice daily for 5-8 days.
Placebo Comparator: 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.
 Other: placebo
Oral placebo twice daily for 5-8 days.


Outcome Measures
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Primary Outcome Measures :
  1. Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule. [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602420


Locations
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
CCOP - Evanston
Evanston, Illinois, United States, 60201
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Michigan
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, United States, 55416
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, New York
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, United States, 13215
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43215
CCOP - Dayton
Dayton, Ohio, United States, 45429
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Washington
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Gary Morrow
National Cancer Institute (NCI)
Investigators
Study Chair: Jeffrey J. Kirshner, MD CCOP - Hematology-Oncology Associates of Central New York
Study Chair: Gary R. Morrow, PhD, MS University of Rochester
Study Chair: Jeffrey K. Giguere, MD, FACP CCOP - Greenville
More Information
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Responsible Party: Gary Morrow, Director, URCC / University of Rochester NCORP Research Base, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier: NCT00602420     History of Changes
Other Study ID Numbers: CDR0000584341
U10CA037420 ( U.S. NIH Grant/Contract )
URCC-07079 ( Other Identifier: URCC )
First Posted: January 28, 2008    Key Record Dates
Results First Posted: May 12, 2015
Last Update Posted: November 9, 2015
Last Verified: October 2015

Keywords provided by Gary Morrow, University of Rochester NCORP Research Base:
pain
musculoskeletal complications
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action