Albumin-bound Paclitaxel (ABI-007) for Patients With Advanced Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Carcinoma
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Albumin-bound paclitaxel; Paclitaxel; Carboplatin
Intervention description: Administered by intravenous infusion.; Administered by intravenous infusion.; Administered by intravenous infusion. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate [GFR] + 25). For the purposes of this protocol, the GFR is considered to be equivalent to creatinine clearance (calculated by the method of Cockcroft and Gault, 1976).
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1052.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Non-Small Cell Lung Cancer

Summary:

      The purpose of this study is to compare disease response of Albumin-bound paclitaxel
      (ABI-007) plus Carboplatin versus Taxol and Carboplatin as first-line therapy in patients
      with advanced non-small cell lung cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer
             (NSCLC)

          -  Male or non-pregnant and non-lactating female, and equal or greater than age 18

               -  If a female patient is of child-bearing potential, as evidence by regular
                  menstrual periods, she must have a negative serum pregnancy test (beta human
                  chorionic gonadotropin [βhCG]) documented within 72 hours of the first
                  administration of study drug

               -  If sexually active, the patient must agree to utilize contraception considered
                  adequate and appropriate by the investigator

          -  No other current active malignancy

          -  Radiographically-documented measurable disease (defined by the presence of at least 1
             radiographically documented measurable lesion)

          -  Patients must have received no prior chemotherapy for the treatment of metastatic
             disease. Adjuvant chemotherapy permitted providing cytotoxic chemotherapy was
             completed 12 months prior to starting the study

          -  Patient has the following blood counts at baseline:

               -  Absolute neutrophil count (ANC) greater than or equal to 1.5x10^9/L

               -  Platelets greater than or equal to 100x10^9/L

               -  Hemoglobin (Hgb) greater than or equal to 9 g/dL

          -  Patient has the following blood chemistry levels at baseline:

               -  Aspartate aminotransferase (SGOT), alanine aminotransferase (SGPT) less than or
                  equal to 2.5 x upper limit of normal range (ULN) or less than or equal to 5.0 x
                  ULN if liver metastases;

               -  Total bilirubin less than or equal to ULN

               -  Creatinine less than or equal to 1.5 mg/dL

          -  Expected survival of greater than 12 weeks

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Patient or his/her legally authorized representative or guardian has been informed
             about the nature of the study, and has agreed to participate in the study, and signed
             the Informed Consent form prior to participation in any study-related activities

        Exclusion Criteria:

          -  Evidence of active brain metastases, including leptomeningeal involvement. Prior
             evidence of brain metastasis permitted only if treated and stable and off therapy for
             greater than or equal to 1 month

          -  The only evidence of disease is non-measurable

          -  Patient has pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per Common
             Terminology Criteria for Adverse Events [CTCAE] Version 3).

          -  Patient received radiotherapy in the last 4 weeks, except if to a non-target lesion
             only. Prior radiation to a target lesion is permitted only if there has been clear
             progression of the lesion since radiation was completed

          -  Patient has a clinically significant concurrent illness

          -  Patient has received treatment with any investigational drug within the previous 4
             weeks

          -  Patient has a history of allergy or hypersensitivity to any of the study drugs

          -  Patient has serious medical risk factors involving any of the major organ systems such
             that the investigator considers it unsafe for the patient to receive an experimental
             research drug

          -  Patient is enrolled in any other clinical protocol or investigational trial that
             involves administration of experimental therapy and/or therapeutic devices.