Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

University of Rochester

ClinicalTrials.gov Identifier:

NCT00602420

First received: January 22, 2008

Last updated: January 31, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 22, 2008

Last Updated Date

January 31, 2013

Start Date ^ICMJE

June 2008

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary [ Time Frame: from baseline through day 5 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00602420 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Potential risk factors for the development of pegfilgrastim-induced bone pain [ Time Frame: at time of onstudy ] [ Designated as safety issue: No ]
Potential clinical predictors for response or failure to respond to treatment [ Time Frame: at enrollment ] [ Designated as safety issue: No ]
Presence or severity of symptoms [ Time Frame: at enrollment and at off study-5 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

Official Title ^ICMJE

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

Brief Summary

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.

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 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Musculoskeletal Complications
Pain
Unspecified Adult Solid Tumor, Protocol Specific

Intervention ^ICMJE

Drug: naproxen
Oral naproxen twice daily for 5-8 days.
Other: placebo
Oral placebo twice daily for 5-8 days.

Study Arm (s)

Experimental: 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.

Intervention: Drug: naproxen
Placebo Comparator: 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.

Intervention: Other: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

512

Estimated Completion Date

May 2014

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00602420

Other Study ID Numbers ^ICMJE

CDR0000584341, U10CA037420, URCC-07079

Has Data Monitoring Committee

Yes

Responsible Party

University of Rochester

Study Sponsor ^ICMJE

University of Rochester

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

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

Information Provided By

University of Rochester

Verification Date

January 2013

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

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