Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U10CA037420 | U.S. NIH Grant/Contract | View source | |
| URCC-07079 | Other Identifier | URCC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
Primary
Secondary
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naproxen | 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. |
|
| Placebo | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| naproxen | Drug | Oral naproxen twice daily for 5-8 days. |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MBCCOP - Hawaii | Honolulu | Hawaii | 96813 | United States | ||
| CCOP - Central Illinois |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Naproxen | Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days. naproxen: Oral naproxen twice daily for 5-8 days. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
Oral placebo twice daily for 5-8 days. |
|
| Decatur |
| Illinois |
| 62526 |
| United States |
| CCOP - Evanston | Evanston | Illinois | 60201 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Hematology-Oncology Associates of Central New York | Syracuse | New York | 13215 | United States |
| CCOP - Southeast Cancer Control Consortium | Goldsboro | North Carolina | 27534-9479 | United States |
| CCOP - Columbus | Columbus | Ohio | 43215 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| CCOP - Greenville | Greenville | South Carolina | 29615 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| CCOP - Virginia Mason Research Center | Seattle | Washington | 98101 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405-0986 | United States |
| CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | 54449 | United States |
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.
placebo: Oral placebo twice daily for 5-8 days.
| COMPLETED |
|
| NOT COMPLETED |
|
|
At least 145 evaluable patients in each treatment group, thus 290 evaluable patients in total, required for an 80% power analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Naproxen | Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days. naproxen: Oral naproxen twice daily for 5-8 days. |
| BG001 | Placebo | 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. placebo: Oral placebo twice daily for 5-8 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | 86% female, 14% male patients. | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Tumor Type | Patients required to have diagnosis of nonmyeloid cancer and were approached for study participation before first dose of pegfilgrastim on day 2, 3, or 4 of chemotherapy cycle. | Number | participants |
| |||||||||||||||
| Marital Status | Number | participants |
| ||||||||||||||||
| Education | Number | participants |
| ||||||||||||||||
| Previous tamoxifen | Number | participants |
| ||||||||||||||||
| Previous chemotherapy | Number | participants |
| ||||||||||||||||
| Previous Radiation Therapy | Number | participants |
| ||||||||||||||||
| Pain at its worst in last 24 hours (scale, 0-10) | Any rating of bone pain from 1 to 10 was considered a day with pain. "No pain" is an instance in which patients scored their pain 0, and "any pain" for all other responses. Severe pain was similarly defined as any bone pain score greater than 5. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Bone pain today or during previous 3 days (scale, 0-10) | Any rating of bone pain from 1 to 10 was considered a day with pain. "No pain" is an instance in which patients scored their pain 0, and "any pain" for all other responses. Severe pain was similarly defined as any bone pain score greater than 5. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | (Pain Scale Score)*Days | From baseline through day 5 |
|
|
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Naproxen | Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days. naproxen: Oral naproxen twice daily for 5-8 days. | 5 | 257 | 4 | 257 | ||
| EG001 | Placebo | 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. placebo: Oral placebo twice daily for 5-8 days. | 3 | 253 | 3 | 253 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular tachycardia (SVT); Rash | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Infection - right breast w/ cellulitis, normal ANC | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Endocrine disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Acute pain secondary to marrow expansion | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hospitalized d/t NV, Diarrhea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Neutropenic fever | Infections and infestations | MedDRA 10.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles E. Heckler, PhD, MS. Research Assistant Professor | University of Rochester Medical Center | 585-273-1141 | checkler@urmc.rochester.edu |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Gynecologic |
|
| Hematologic |
|
| Lung |
|
| Other |
|
| Not Married |
|
| Unknown |
|
| High school or less |
|
| Other |
|
| No |
|
| Unknown |
|
| No |
|
| Unknown |
|
| No |
|
| Unknown |
|
| Wilcoxon (Mann-Whitney) |
| 0.007 |
| 2-Sided |
| No |
| Superiority or Other |