Study of Abraxane and Carboplatin to Treat Small Cell Lung Cancer
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Carboplatin; Abraxane
Intervention description: Carboplatin will be given at a dose of target area under the concentration versus time curve in mg/mL•min (AUC)=6, on Day 1 of a 21 Day Cycle; Abraxane will be given at a dose of 240mg/m2 on Day 1 of a 21 Day Cycle (Arm A)
Abraxane will be given at a dose of 80mg/m2 on Days 1, 8, and 15 of a 21 Day Cycle (Arm B)
Intervention MeSH terms: Paclitaxel; Carboplatin; Albumin-Bound Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung cancer; Small cell lung cancer; Abraxane; Paclitaxel; Carboplatin; Phase II; Randomized; Lineberger; LCCC

Summary:

      This is a phase II trial of abraxane and carboplatin in extensive stage small cell lung
      cancer to examine overall response rate, time to progressive disease, survival time, and
      assessment of toxicity profile for Carboplatin and Abraxane.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histological or cytological diagnosis of extensive stage small-cell lung cancer
             (ES-SCLC),* including malignant pleural effusion

          2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

          3. No prior systemic chemotherapy, immunotherapy, or biological therapy for SCLC

          4. Measurable disease as defined by the RECIST criteria

          5. Adequate organ function as defined by the protocol

          6. Female patients of child bearing potential (CBP) must agree to use of reliable method
             of birth control during and for 3 months following treatment

          7. Patients must sign informed consent document

          8. Patients must be ≥ 18 years of age

          9. Patients with brain metastases that have been adequately treated and are determined to
             be controlled by the attending physician are eligible

         10. Patients who have had prior malignancies are eligible if they are ≥ 5 years from
             diagnosis free of disease or the attending physician believes the patient's prognosis
             is best defined by the ES-SCLC (if questions concerning this eligibility criteria
             arise, please contact the principal investigator)

        (*)ES-SCLC defined as metastases outside the chest, pulmonary metastases, or contralateral
        metastases (supraclavicular or hilar) nodes that could not be included with a reasonable
        single radiation port. Patients with malignant pleural effusions are considered extensive
        stage.

        Exclusion Criteria:

          1. Received treatment within the last 30 days with a drug that has not received Food and
             Drug Administration (FDA) approval for any indication at the time of study entry

          2. Pregnancy or breast feeding

          3. Serious active infection that would require a prolonged course (4-6 weeks) of
             antibiotics or would compromise the safety of the patient or compromise the patient's
             ability to complete the study

          4. Symptomatic brain metastases

          5. Grade ≥ 2 neuropathy using NCI CTCAE version 3.0 criteria

          6. Previous anaphylactic reaction to carboplatin, paclitaxel, and docetaxel

          7. Severe or uncontrolled cardiac disease, defined as uncontrolled or unstable angina,
             myocardial infarction in the last month, uncontrolled congestive heart failure (≥ 3
             admissions for congestive heart failure in the 3 months prior to diagnosis)