Clinical Trial: Safety and Efficacy Study of Abraxane in Combination With Carboplatin to Treat Advanced NSCL Cancer in the Elderly

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Safety and Efficaty of Nab-paclitaxel (Abraxane) in Combination With Carboplatin as First Line Treatment in Elderly Subjects With Advance Non-Small Cell Lung Cancer (NSCLC): A Phase IV, Randomized, Op

Brief Summary: Study comparing two regimens of nab-paclitaxel and carboplatin combination in elderly subject (≥ 70 years old) with advanced NSCLC

Detailed Summary: This is a Phase IV, randomized, open-label, multicenter study of continuous weekly versus weekly times three with one-week break nab-paclitaxel in combination with carboplatin as first-line treatment in elderly subjects (≥ 70 years old) with advanced non small cell lung cancer who have not received prior chemotherapy for their advanced disease and are not candidates for curative surgery or radiation therapy. The primary study endpoint is the percentage of subjects with either peripheral neuropathy or myelosuppression adverse events. Patients will continue treatment until they develop progressive disease, unacceptable side-effects or wish to withdraw from the study, according to local standard of care. Patients will have radiographic evaluations every 6 weeks while on treatment.
Sponsor: Celgene Corporation

Current Primary Outcome: Percentage of participants who will experience either peripheral neuropathy or myelosuppression [ Time Frame: Up to 28 months ]

The peripheral neuropathy events will be identified from the clinical AE dataset using MedDRA. Myelosuppression will be assessed as an adverse event based on laboratory values. All AEs will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4.0).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The type, frequency and severity of AEs and SAEs [ Time Frame: Up to 28 months ]
    An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any clinically significant change in the frequency or intensity of a pre-existing condition should be considered an AE. TEAEs will be analyzed which are defined as any AE or SAE occurring or worsening on or after the first dose of the study drug through 28 days after the last dose of study drug. Any serious AE with an onset date more than 28 days after the last dose of study drug that is assessed as related to study drug will be considered a TEAE. AEs will be coded according to the Medical Dictionary for Regulatory Activities. The severity of AEs will be graded based on NCI Common Terminology Criteria for Adverse Events, Version 4.0.
  • Discontinuation Rate [ Time Frame: Up to 28 months ]
    Percentage of participants who will discontinue from study due to progressive disease, toxicity, withdrawal from study, protocol violation or other specified reasons
  • Dose Intensity [ Time Frame: Up to 28 months ]
    Dose of ABI-007 delivered per unit of time (mg/m2/week)
  • Incidence of dose reduction or delay [ Time Frame: Up to 28 months ]
    The number of participants with dose reductions and dose delays that occur during the treatment period. Dose reductions and delays are typically caused by clinically significant laboratory abnormalities and/or treatment emergent adverse events/toxicities.
  • Progression-free Survival [ Time Frame: Up to 28 months ]
    Time from the date of randomization to the date of disease progression or death (any cause) on or prior to the data cutoff date for analyses, whichever occurred first, based on the assessment of the data from CT scans using RECIST 1.1 guidelines.
  • Overall Survival [ Time Frame: Up to 28 months ]
    Time between randomization and death
  • Overall response Rate [ Time Frame: Up to 28 months ]
    The portion of patients with a tumor reduction of predefined amount for a minimum time period


Original Secondary Outcome: Same as current

Information By: Celgene Corporation

Dates:
Date Received: May 28, 2014
Date Started: June 2014
Date Completion: December 2017
Last Updated: October 24, 2016
Last Verified: October 2016