Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gary Morrow, University of Rochester
ClinicalTrials.gov Identifier:
NCT00602420
First received: January 22, 2008
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Musculoskeletal Complications
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Drug: naproxen
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary [ Time Frame: from baseline through day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Potential risk factors for the development of pegfilgrastim-induced bone pain [ Time Frame: at time of onstudy ] [ Designated as safety issue: No ]
  • Potential clinical predictors for response or failure to respond to treatment [ Time Frame: at enrollment ] [ Designated as safety issue: No ]
  • Presence or severity of symptoms [ Time Frame: at enrollment and at off study-5 days ] [ Designated as safety issue: No ]

Enrollment: 512
Study Start Date: June 2008
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: naproxen
Oral naproxen twice daily for 5-8 days.
Placebo Comparator: Arm II
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.

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 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Creatinine ≤ 1.5 times upper limit of normal
  • Able to understand English
  • No clinical evidence of active gastrointestinal bleeding, prior gastrointestinal bleeding, or gastric or duodenal ulcers
  • No known allergy to naproxen
  • No prior development of the triad of asthma, rhinitis, and nasal polyps after taking acetylsalicylic acid (aspirin) or other NSAIDs

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 6 months since prior surgery on the heart
  • No 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
  • No concurrent steroids on a regular basis
  • No concurrent prescription or non-prescription medications for preexisting chronic pain

    • Concurrent cardioprotective doses (≤ 325 mg/day) of aspirin allowed
  • No concurrent therapeutic doses of warfarin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
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

Additional Information:
No publications provided

Responsible Party: Gary Morrow, Director, URCC CCOP Research Base, University of Rochester
ClinicalTrials.gov Identifier: NCT00602420     History of Changes
Other Study ID Numbers: CDR0000584341, U10CA037420, URCC-07079
Study First Received: January 22, 2008
Last Updated: January 31, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Rochester:
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014