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S. Chawla



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

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

      • 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.

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