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Naproxen in Preventing Bone Pain Caused by Pegfilgrastim in Patients With Non-Hematologic Cancer Undergoing Chemotherapy

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2008

Sponsors and Collaborators: University of Rochester
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00602420
  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
Drug: placebo
Phase III

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   Pegfilgrastim    Naproxen sodium    Naproxen   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:   Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial

Further study details as provided by National Cancer Institute (NCI):

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

Secondary Outcome Measures:
  • Potential risk factors for the development of pegfilgrastim-induced bone pain [ Designated as safety issue: No ]
  • Potential clinical predictors for response or failure to respond to treatment [ Designated as safety issue: No ]
  • Presence or severity of symptoms prior to study enrollment and at study outcome as measured by the Symptom Inventory [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:   322
Study Start Date:   June 2008
Estimated Primary Completion Date:   July 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Arm I: Experimental
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.
Arm II: Placebo Comparator
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.
Drug: 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 of 2 treatment arms.

  • 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 an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.

Patients complete questionnaires, including the Symptom Inventory and Brief Pain Inventory, at baseline and after completion of study treatment. Patients also complete a daily pain diary during study treatment.

  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, New York
CCOP - Hematology-Oncology Associates of Central New York     Recruiting
      Syracuse, New York, United States, 13215
      Contact: Jeffrey J. Kirshner, MD     315-472-7504        
University of Rochester Cancer Center CCOP Research Base     Recruiting
      Rochester, New York, United States, 14642
      Contact: Gary R. Morrow, PhD, MS     585-275-5513        
United States, South Carolina
CCOP - Greenville     Recruiting
      Greenville, South Carolina, United States, 29615
      Contact: Jeffrey K. Giguere, MD, FACP     864-987-7000     Jeffrey.Giguere@usoncology.com    

Sponsors and Collaborators
University of Rochester
National Cancer Institute (NCI)

Investigators
Study Chair:     Jeffrey J. Kirshner, MD     CCOP - Hematology-Oncology Associates of Central New York    
Investigator:     Gary R. Morrow, PhD, MS     University of Rochester    
Investigator:     Jeffrey K. Giguere, MD, FACP     CCOP - Greenville    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000584341, URCC-07079
First Received:   January 22, 2008
Last Updated:   October 8, 2008
ClinicalTrials.gov Identifier:   NCT00602420
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
pain  
musculoskeletal complications  
unspecified adult solid tumor, protocol specific  

Study placed in the following topic categories:
Naproxen
Pain

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

ClinicalTrials.gov processed this record on October 10, 2008




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