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NCT00112736 · OUTCOME

Efficacy - Response Phase 1

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.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
at least 8 weeks of treatment

What was measured

pt must have at least 8 weeks of treatment to receive MRI scan, scans are every other cycle (every 2 months). Response measured by a bidimensionally measured leison and clearly defined margins by CT or MRI scan. Complete Response (CR): complete disappearance of all measurable and evaluable disease. No new lesions, not on any steroids Partial Response (PR): \>= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Steriod dose must be no greater than max used in 1st 8wks of therapy Stable: not qualify for CR, PR, or progression. Steriod dose must be no greater than max used in 1st 8wks of therapy Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer).

Analysis population: Response was reviewed only in those patients treated at the MTD (15mg temsirolimus)

Groups in this outcome

Phase I 15mg Temsirolimus (MTD Dose)

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase I 15mg Temsirolimus (MTD Dose)12

Reported measurements

Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I 15mg Temsirolimus (MTD Dose)0Not reportedNot reportedNot reportedNot reported
Partial response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I 15mg Temsirolimus (MTD Dose)1Not reportedNot reportedNot reportedNot reported
Stable
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I 15mg Temsirolimus (MTD Dose)2Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I 15mg Temsirolimus (MTD Dose)9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Partial response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Stable
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
pt must have at least 8 weeks of treatment to receive MRI scan, scans are every other cycle (every 2 months). Response measured by a bidimensionally measured leison and clearly defined margins by CT or MRI scan. Complete Response (CR): complete disappearance of all measurable and evaluable disease. No new lesions, not on any steroids Partial Response (PR): \>= 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. Steriod dose must be no greater than max used in 1st 8wks of therapy Stable: not qualify for CR, PR, or progression. Steriod dose must be no greater than max used in 1st 8wks of therapy Progression (PD): 25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening or failure to return for evalution due to death or deteriorating condition (unless clearly unrelated to brain cancer).
groups
  1. description
    PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity. erlotinib: Given orally temsirolimus: Given IV
    id
    OG000
    title
    Phase I 15mg Temsirolimus (MTD Dose)
param Type
NUMBER
population Description
Response was reviewed only in those patients treated at the MTD (15mg temsirolimus)
reporting Status
POSTED
time Frame
at least 8 weeks of treatment
title
Efficacy - Response Phase 1
type
PRIMARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice