NOLAN: Naproxen or Loratadine and Neulasta
Keywords
Abstract
Description
In this study, the investigational products are naproxen, a non-steroidal antiinflammatory drug (NSAID), and loratadine, an anti-histamine. Both agents are being investigated as prophylactic medications to reduce the incidence and/or severity of bone pain in breast cancer patients receiving adjuvant or neoadjuvant myelosuppressive chemotherapy and pegfilgrastim prophylaxis.
Pegfilgrastim treatment is used to stimulate bone marrow to produce more neutrophils to help fight infections in patients undergoing chemotherapy.
Dates
| Last Verified: | 12/31/2017 |
| First Submitted: | 10/18/2012 |
| Estimated Enrollment Submitted: | 10/18/2012 |
| First Posted: | 10/22/2012 |
| Last Update Submitted: | 01/04/2018 |
| Last Update Posted: | 01/29/2018 |
| Date of first submitted results: | 02/08/2016 |
| Date of first submitted QC results: | 02/08/2016 |
| Date of first posted results: | 03/08/2016 |
| Actual Study Start Date: | 10/31/2012 |
| Estimated Primary Completion Date: | 03/17/2015 |
| Estimated Study Completion Date: | 03/17/2015 |
Condition or disease
Intervention/treatment
Drug: Prophylactic naproxen
Drug: Prophylactic loratadine
Biological: Pegfilgrastim
Drug: Chemotherapy
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Prophylactic naproxen Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration. | Drug: Prophylactic naproxen |
| Experimental: Prophylactic loratadine Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration. | Drug: Prophylactic loratadine |
| Other: No prophylactic treatment Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | Age 18 years or over - Eastern cooperative oncology group (ECOG) performance status 0-2 - Female with newly diagnosed, not previously treated with chemotherapy, stage I-III breast cancer - Medically eligible to safely receive adjuvant or neoadjuvant chemotherapy, pegfilgrastim, naproxen and loratadine as determined by the investigator - Creatinine ≤ 1.5 X upper limit of normal (ULN) - Planning to receive at least 4 cycles of adjuvant or neoadjuvant chemotherapy - Planning to receive prophylaxis with pegfilgrastim starting in the first cycle and continuing throughout each chemotherapy cycle of the treatment period - Subject has provided informed consent Exclusion Criteria - History of other malignancy within the past 5 years, with the following exceptions: - Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease - Adequately treated cervical carcinoma in situ without evidence of disease - Planning to receive weekly chemotherapy - Ongoing chronic pain, or other painful conditions requiring treatment (including immediate post-operative treatment of surgical or procedural-associated pain) as determined by the investigator - Chronic oral steroid use. Premedication related to the administration of chemotherapy, and use of anti-emetics is allowed, per usual clinical practice - Chronic use of oral non-steroidal anti-inflammatory drug (NSAIDs) or oral antihistamines outside of those dictated by the randomization groups outlined in the protocol, with the following exception: - Chronic oral aspirin use for cardiovascular-related indications - Prior chemotherapy treatment for cancer within 5 years of current breast cancer diagnosis - Prior use of granulocyte colony stimulating factor (G-CSF) - History of clinically significant gastrointestinal (GI) bleeding, history of GI ulcers or active GI bleeding within 6 months prior to randomization - History of clinically significant bleeding disorders, thromboembolism within 6 months prior to randomization - Currently enrolled in, or less than 30 days since ending, another clinical trial which includes language directing G-CSF (filgrastim, pegfilgrastim, other) or granulocyte-macrophage colony-stimulating factor (GM-CSF) (sargramostim) use - Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes a blinded treatment or blinded treatment arm (whether or not the subject is randomized to the blinded arm) - Currently enrolled in, or less than 30 days since ending, another interventional clinical trial which includes the use of any agent not currently considered to be standard therapy for the adjuvant or neoadjuvant treatment of stage I-III breast cancer based on National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Breast Cancer - Currently enrolled in, or less than 30 days since ending, any pain intervention study - Female subjects who are pregnant or lactating or of reproductive potential not willing to employ an effective method of birth control during treatment and for 17 days after discontinuing study treatment - History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Amgen, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion |
Outcome
Primary Outcome Measures
1. Percentage of Participants With Bone Pain (All Grades) in Cycle 1 [Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval)]
Secondary Outcome Measures
1. Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles [Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)]
2. Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles [Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval)]
3. Mean Patient-reported Bone Pain by Cycle and Across Cycles [Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)]
4. Maximum Patient-reported Bone Pain by Cycle and Across Cycles [Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)]
5. Area Under the Curve (AUC) for Patient-reported Bone Pain [Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle)]
6. Number of Participants With Adverse Events (AEs) [From first dose of investigational product (IP, naproxen or loratidine) or first dose of pegfilgrastim (Peg), whichever occurred first, until 30 days after last dose, up to 24 weeks.]
