Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Active 18 and over NCI URCC-07079 URCC07079, URCC-06-06, NCT00602420

Objectives

Primary

1. 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

1. To identify potential risk factors for the development of PIBP.
2. To identify potential clinical predictors for the response or failure to respond to naproxen in preventing PIBP.
3. To assess the toxicity of naproxen when administered in the preventive setting.

Entry 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

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

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

Expected Enrollment

Outcomes

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

Potential risk factors for the development of pegfilgrastim-induced bone pain
Potential clinical predictors for response or failure to respond to treatment
Presence or severity of symptoms prior to study enrollment and at study outcome as measured by the Symptom Inventory
Toxicity

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.

Trial Contact Information

Trial Lead Organizations

University of Rochester Cancer Center CCOP Research Base

Jeffrey Kirshner, MD, Protocol chair		Ph: 315-472-7504 Email: jkirshner@hoacny.com
Gary Morrow, PhD, MS, Protocol co-chair		Ph: 585-275-5513
Jeffrey Giguere, MD, FACP, Protocol co-chair		Ph: 864-241-6251

U.S.A.
New York
	Rochester
	University of Rochester Cancer Center CCOP Research Base
		Gary Morrow, PhD, MS	Ph:  585-275-5513
	Syracuse
	CCOP - Hematology-Oncology Associates of Central New York
		Jeffrey Kirshner, MD	Ph:  315-472-7504
South Carolina
	Greenville
	CCOP - Greenville
		Jeffrey Giguere, MD, FACP	Ph:  864-987-7000
			Email: Jeffrey.Giguere@usoncology.com

Registry Information
Official Title		Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial
Trial Start Date		2008-06-10
Trial Completion Date		2011-07-01 (estimated)
Registered in ClinicalTrials.gov		NCT00602420
Date Submitted to PDQ		2008-01-08
Information Last Verified		2008-08-12