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Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Musculoskeletal Complications, Pain, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary

Outcome Time Frame:

from baseline through day 5

Safety Issue:

No

Principal Investigator

Jeffrey J. Kirshner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

CCOP - Hematology-Oncology Associates of Central New York

Authority:

United States: Federal Government

Study ID:

CDR0000584341

NCT ID:

NCT00602420

Start Date:

June 2008

Completion Date:

May 2014

Related Keywords:

  • Musculoskeletal Complications
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • pain
  • musculoskeletal complications
  • unspecified adult solid tumor, protocol specific

Name

Location

MBCCOP - HawaiiHonolulu, Hawaii  96813
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
CCOP - NorthwestTacoma, Washington  98405-0986
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057