Participant flow

Erlotinib and Temsirolimus in Treating Patients With Recurrent Malignant Glioma · Source last updated 2015-06-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity. erlotinib: Given orally temsirolimus: Given IV pharmacological study: Correlative studies

   id

   FG000

   title

   Phase I (Erlotinib & Temsirolimus)

2. description

   Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity. PHASE II (preoperative component): Patients who are surgical candidates may opt to undergo surgical resection of the tumor. Beginning 5-7 days before surgery, these patients receive oral erlotinib once daily until surgery. Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later. Beginning 2-4 weeks after surgery, patients receive temsirolimus at the MTD and erlotinib as in phase I. therapeutic conventional surgery: Undergo surgical resection laboratory biomarker analysis: Correlative studies

   id

   FG001

   title

   Phase II (Erlotinib & Temsirolimus)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      1 pt never had had RX due rapid decline

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         47

      type

      STARTED

   2. achievements

      1. comment

         12 of Phase I pts treated at MTD and hence considered part of the Phase II analysis

         group Id

         FG000

         num Subjects

         21

      2. comment

         12 additional pts from phase 1 study were used in analysis for Phase 2 as they were treated at MTD

         group Id

         FG001

         num Subjects

         47

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Patients were enrolled between 2005 and 2008. Patients were recruited from outpatient medical clinics and referrals.

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Preserved source evidence · Not medical advice