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NCT01057589 · OUTCOME

Overall Survival (OS)

A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer · Source last updated 2013-09-18

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline to date of death up to 18.7 months

What was measured

OS defined as the time from the date of first dose of study drug to the date to death from any cause.

Analysis population: PQ Population: all randomized and treated participants

Groups in this outcome

Pemetrexed Cisplatin Cetuximab

Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.

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

Analysis denominator · Participants

GroupSource count
Pemetrexed Cisplatin Cetuximab66

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemetrexed Cisplatin Cetuximab9.7Not reported6.513.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.5
        upper Limit
        13.1
        value
        9.7
denoms
  1. counts
    1. group Id
      OG000
      value
      66
    units
    Participants
description
OS defined as the time from the date of first dose of study drug to the date to death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
    id
    OG000
    title
    Pemetrexed Cisplatin Cetuximab
param Type
MEDIAN
population Description
PQ Population: all randomized and treated participants
reporting Status
POSTED
time Frame
Baseline to date of death up to 18.7 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice