Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial
18 Years
N/A
Both
Musculoskeletal Complications, Pain, Unspecified Adult Solid Tumor, Protocol Specific
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 - Hawaii | Honolulu, Hawaii 96813 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| CCOP - Evanston | Evanston, Illinois 60201 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
