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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00602420
Other study ID # CDR0000584341
Secondary ID U10CA037420URCC-
Status Completed
Phase Phase 3
First received January 22, 2008
Last updated October 13, 2015
Start date June 2008
Est. completion date March 2012

Study information

Verified date October 2015
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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 Clinical Community Oncology Program (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.


Recruitment information / eligibility

Status Completed
Enrollment 510
Est. completion date March 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 120 Years
Eligibility Inclusion Criteria:

- 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

- Creatinine = 1.5 times upper limit of normal

- Able to understand English

- More than 6 months since prior surgery on the heart

Exclusion Criteria:

- Pregnant or nursing

- Clinical evidence of active gastrointestinal bleeding, prior gastrointestinal bleeding, or gastric or duodenal ulcers

- Allergy to naproxen

- Prior development of the triad of asthma, rhinitis, and nasal polyps after taking acetylsalicylic acid (aspirin) or other NSAIDs

- 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

- Concurrent steroids on a regular basis

- Concurrent prescription or non-prescription medications for preexisting chronic pain; concurrent cardioprotective doses (= 325 mg/day) of aspirin allowed

- Concurrent therapeutic doses of warfarin

Study Design

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States CCOP - Columbus Columbus Ohio
United States CCOP - Dayton Dayton Ohio
United States CCOP - Central Illinois Decatur Illinois
United States CCOP - Evanston Evanston Illinois
United States CCOP - Southeast Cancer Control Consortium Goldsboro North Carolina
United States CCOP - Grand Rapids Grand Rapids Michigan
United States CCOP - Greenville Greenville South Carolina
United States MBCCOP - Hawaii Honolulu Hawaii
United States CCOP - Kansas City Kansas City Missouri
United States CCOP - Marshfield Clinic Research Foundation Marshfield Wisconsin
United States CCOP - Virginia Mason Research Center Seattle Washington
United States CCOP - Upstate Carolina Spartanburg South Carolina
United States CCOP - Metro-Minnesota St. Louis Park Minnesota
United States CCOP - Hematology-Oncology Associates of Central New York Syracuse New York
United States CCOP - Northwest Tacoma Washington
United States CCOP - Wichita Wichita Kansas

Sponsors (2)

Lead Sponsor Collaborator
Gary Morrow National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule. Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary. Patients recorded daily pain (Pain Scale Score) severity on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) for the last 24 hours. The AUC range was 0-40, and the units are (Pain Scale Score)*Days. From baseline through day 5 No
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