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NCT00589667 · OUTCOME

Overall Objective Response

A Phase II Study of Pemetrexed Plus Gemcitabine for Metastatic/Recurrent Head and Neck Cancer (HNSCC) · Source last updated 2014-04-02

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
2 years

What was measured

To determine the objective radiologic response rate of pemetrexed and gemcitabine in patients with recurrent or metastatic Head and Neck Squamouse Cell Carcinoma. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Analysis population: All assessable patients as indicated in the protocol.

Groups in this outcome

Pemetrexed Plus Gemcitabine

Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.

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 Plus Gemcitabine25

Reported measurements

Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed Plus Gemcitabine4Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed Plus Gemcitabine18Not reportedNot reportedNot reportedNot reported
Progression of Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed Plus Gemcitabine2Not reportedNot reportedNot reportedNot reported
Response not available
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pemetrexed Plus Gemcitabine1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Partial Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Stable Disease
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Progression of Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Response not available
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
To determine the objective radiologic response rate of pemetrexed and gemcitabine in patients with recurrent or metastatic Head and Neck Squamouse Cell Carcinoma. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
groups
  1. description
    Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
    id
    OG000
    title
    Pemetrexed Plus Gemcitabine
param Type
NUMBER
population Description
All assessable patients as indicated in the protocol.
reporting Status
POSTED
time Frame
2 years
title
Overall Objective Response
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice