NOLAN: Naproxen or Loratadine and Neulasta

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01712009
First received: October 19, 2012
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine On Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim


Condition Intervention Phase
Bone Pain in Stage I - III Breast Cancer
Drug: Naproxen
Drug: Loratadine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Bone pain (all grade) in cycle 1 [ Time Frame: Will be assessed 30 days after all subjects complete chemotherapy ] [ Designated as safety issue: No ]
    To estimate the difference in cycle 1 bone pain (all grade) between treatment groups (naproxen, loratadine, or no therapy) captured as part of adverse event (AE) reporting


Secondary Outcome Measures:
  • Bone pain (all grade) by cycle (2-4) and across cycles [ Time Frame: Will be assessed 30 days after all subjects complete chemotherapy ] [ Designated as safety issue: No ]
    Bone pain (all grade) by cycle (2-4) and across cycles (up to and including 4 cycles)

  • Severe (grade 3/4) bone pain by cycle and across cycles [ Time Frame: Will be assessed 30 days after all subjects complete chemotherapy ] [ Designated as safety issue: No ]
    Severe (grade 3/4) bone pain by cycle and across cycles (up to and including 4 cycles)

  • Subject reported bone pain [ Time Frame: Will be assessed 30 days after all subjects complete chemotherapy ] [ Designated as safety issue: No ]
    Subject-reported bone pain by cycle and across cycles (up to and including 4 cycles)

  • Maximum Subject Reported bone pain [ Time Frame: Will be assessed 30 days after all subjects complete chemotherapy ] [ Designated as safety issue: No ]
    Maximum subject-reported bone pain by cycle and across cycles (up to and including 4 cycles)

  • Area under the Curve for subject-reported bone pain [ Time Frame: Will be assessed 30 days after all subjects complete chemotherapy ] [ Designated as safety issue: No ]
    AUC for subject-reported bone pain during by cycle and across all cycles (up to and including 4)

  • Adverse Event and Serious Adverse Events [ Time Frame: Will be assessed 30 days after all subjects complete chemotherapy ] [ Designated as safety issue: Yes ]
    AEs and Serious Adverse Events (SAEs) related to pegfilgrastim, naproxen, or loratadine

  • Severity of Adverse Events [ Time Frame: Will be assessed 30 days after all subjects complete chemotherapy ] [ Designated as safety issue: Yes ]
    Severity of AEs related to pegfilgrastim, naproxen, or loratadine


Estimated Enrollment: 600
Study Start Date: November 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prophylactic naproxen Drug: Naproxen
Subjects will receive prophylactic naproxen 500 mg twice a day (BID) taken orally beginning the day of pegfilgrastim administration, and continuing for 5 days in total
Experimental: Prophylactic loratadine Drug: Loratadine
Subject will receive prophylactic loratadine 10 mg once a day (QD) taken orally beginning the day of pegfilgrastim administration, and continuing for 5 days in total
No Intervention: No prophylactic treatment

Detailed 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 subjects receiving adjuvant or neoadjuvant myelosuppressive chemotherapy and pegfilgrastim prophylaxis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Age 18 years or over

  • 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 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 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 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712009

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 80 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01712009     History of Changes
Other Study ID Numbers: 20110147
Study First Received: October 19, 2012
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Amgen:
Breast cancer
Chemotherapy
Neulasta
Pegfilgrastim
Naproxen
Loratadine
Non-steroidal antiinflammatory drug (NSAID)
Anti-histamine
Bone Pain

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Naproxen
Loratadine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014