Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gary Morrow, University of Rochester
ClinicalTrials.gov Identifier:
NCT00602420
First received: January 22, 2008
Last updated: May 8, 2015
Last verified: May 2015

January 22, 2008
May 8, 2015
June 2008
January 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
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 ]
Complete list of historical versions of study NCT00602420 on ClinicalTrials.gov Archive Site
Not Provided
  • 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 ]
Not Provided
Not Provided
 
Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
  • Musculoskeletal Complications
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: naproxen
    Oral naproxen twice daily for 5-8 days.
    Other Name: naproxen
  • Other: placebo
    Oral placebo twice daily for 5-8 days.
    Other Name: placebo
  • 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.
    Intervention: Drug: naproxen
  • 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.
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
510
March 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00602420
CDR0000584341, U10CA037420, URCC-07079
Yes
Gary Morrow, University of Rochester
Gary Morrow
National Cancer Institute (NCI)
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
University of Rochester
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP