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NCT00425750 · OUTCOME

Patient Response to Treatment

Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer · Source last updated 2011-11-16

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
7.55 months (average duration, on study to off study)

What was measured

Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.

Groups in this outcome

Bortezomib; Docetaxel

Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.

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

Analysis denominator · Participants

GroupSource count
Bortezomib; Docetaxel25

Reported measurements

Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib; Docetaxel1Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib; Docetaxel10Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib; Docetaxel10Not reportedNot reportedNot reportedNot reported
Not Evaluable
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib; Docetaxel4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Partial Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Progressive Disease
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Stable Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Not Evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.
groups
  1. description
    Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
    id
    OG000
    title
    Bortezomib; Docetaxel
param Type
NUMBER
reporting Status
POSTED
time Frame
7.55 months (average duration, on study to off study)
title
Patient Response to Treatment
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice