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

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

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