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

Condition(s) targeted: Cancer-Related Problem/Condition; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Intervention: naproxen (Drug); placebo (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Rochester

Official(s) and/or principal investigator(s):
Jeffrey J. Kirshner, MD, Study Chair, Affiliation: CCOP - Hematology-Oncology Associates of Central New York
Gary R. Morrow, PhD, MS, Affiliation: University of Rochester
Jeffrey K. Giguere, MD, FACP, Affiliation: CCOP - Greenville

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.

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

Study design: Supportive Care, Randomized, Double-Blind, Placebo Control

Primary outcome: 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

Secondary outcome:

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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

MBCCOP - Hawaii, Honolulu, Hawaii 96813, United States; Recruiting
Jeffrey L. Berenberg, MD, Phone: 808-586-2979

CCOP - Central Illinois, Decatur, Illinois 62526, United States; Recruiting
James L. Wade, MD, Phone: 217-876-6617, Email: jlwade3@sbcglobal.net

CCOP - Evanston, Evanston, Illinois 60201, United States; Recruiting
David L. Grinblatt, MD, Phone: 847-570-2109

CCOP - Wichita, Wichita, Kansas 67214-3882, United States; Recruiting
Marge Good, Phone: 316-268-5784, Email: marge_good@via-christi.org

CCOP - Grand Rapids, Grand Rapids, Michigan 49503, United States; Recruiting
Marianne K. Lange, MD, Phone: 616-391-1230, Email: marianne.lange@grcop.org

CCOP - Metro-Minnesota, St. Louis Park, Minnesota 55416, United States; Recruiting
Patrick J. Flynn, MD, Phone: 952-993-1516, Email: patrick.flynn@usoncology.com

CCOP - Kansas City, Kansas City, Missouri 64131, United States; Recruiting
Rakesh Gaur, MD, Phone: 816-823-0555, Email: rgaur@saint-lukes.org

CCOP - Hematology-Oncology Associates of Central New York, Syracuse, New York 13215, United States; Recruiting
Jeffrey J. Kirshner, MD, Phone: 315-472-7504

CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina 27534-9479, United States; Recruiting
James N. Atkins, MD, Phone: 336-777-3036

CCOP - Columbus, Columbus, Ohio 43215, United States; Recruiting
J. Philip Kuebler, MD, PhD, Phone: 614-488-0143, Email: kueblep@ohiohealth.com

CCOP - Dayton, Dayton, Ohio 45429, United States; Recruiting
Howard M. Gross, MD, Phone: 937-395-8678

CCOP - Greenville, Greenville, South Carolina 29615, United States; Recruiting
Jeffrey K. Giguere, MD, FACP, Phone: 864-987-7000, Email: Jeffrey.Giguere@usoncology.com

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States; Recruiting
Clinical Trials Office - CCOP - Upstate Carolina, Phone: 800-486-5941

CCOP - Northwest, Tacoma, Washington 98405-0986, United States; Recruiting
Lauren K. Colman, MD, Phone: 253-403-1461, Email: lauren.colman@multicare.org

CCOP - Virginia Mason Research Center, Seattle, Washington 98101, United States; Recruiting
Jacqueline Vuky, MD, Phone: 206-341-0446

CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin 54449, United States; Recruiting
Clinical Trials Office - CCOP - Marshfield Clinic Research Fou, Phone: 715-389-4457

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: June 2008
Last updated: February 6, 2009