Virtual Library

 x 
My Library Virtual Library FAQ

Start Your Search

S. Wieland



Author of

  • +

    P3.07 - Poster Session/ Small Cell Lung Cancer (ID 223)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Small Cell Lung Cancer
    • Presentations: 1
    • +

      P3.07-006 - Phase 2 Study of Aldoxorubicin versus Topotecan for Relapsed/Refractory Small Cell Lung Cancer (ID 1736)

      09:30 - 09:30  |  Author(s): S. Wieland

      • Abstract
      • Slides

      Background:
      Aldoxorubicin is a novel prodrug that binds to albumin in the circulation. Doxorubicin is cleaved in low pH environments, allowing administration of 3.5-4-fold higher doses than standard doxorubicin and 10-fold greater cumulative doses. Patients with metastatic small cell lung cancer (SCLC) who have failed prior chemotherapies have a poor prognosis with response rates (ORR) of 5-20%, progression-free survival (PFS) of 2-4 months and overall survival of 6-10 months. Topotecan is the standard therapy for these patients.

      Methods:
      Open label study, 132 patients, (1:1 randomization) to receive either aldoxorubicin (230 mg/m[2], IV infusion, Day 1, every 3 weeks) or topotecan (either 1.5 mg/m[2]/day IV, Days 1-5, every 3 weeks or 4 mg/m[2] IV infusion on Days 1, 8, and 15 every 28 days). Key inclusions: confirmed SCLC, relapsed or refractory to ≥ 1 prior chemo, ECOG 0-2, measurable tumor (RECIST 1.1). Key exclusions: >375 mg/m[2 ]prior doxorubicin, prior topotecan, active CNS mets, lab abnormalities (ANC <1500/mm[3], platelets <100,000/mm[3], Hgb <9 gm/dL, LFTs > 3 or 5x ULN), serious myocardial dysfunction, anion gap >16 meq/L or arterial blood pH < 7.30. Key stratifications: relapse < 90 days versus > 90 days; ECOG 0-1 versus 2. Primary endpoint: PFS (analysis after 110 events); assume PFS for topotecan = 3.5 months, aldoxorubicin = 6.5 months. Secondary endpoints: OS (analysis after 110 deaths; assumes OS for topotecan = 6 months, aldoxorubicin = 8 months), ORR, disease control rate, adverse events, tolerability, lab abnormalities. Study sites: Up to 40 sites in the US, Hungary, Spain, and Italy.

      Results:
      Not applicable.

      Conclusion:
      Not applicable.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.