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

Sponsor:	University of Rochester
Collaborator:	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 Other: placebo	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Naproxen Naproxen sodium Pegfilgrastim

U.S. FDA Resources

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.	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 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, 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 - Northwest
Tacoma, Washington, United States, 98405-0986
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
United States, Wisconsin
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449

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

Additional Information:

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

No publications provided

Responsible Party:	James P. Wilmot Cancer Center at University of Rochester Medical Center ( Gary R. Morrow )
Study ID Numbers:	CDR0000584341, URCC-07079
Study First Received:	January 22, 2008
Last Updated:	June 24, 2009
ClinicalTrials.gov Identifier:	NCT00602420 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

pain
musculoskeletal complications
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Naproxen
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 February 08, 2010