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NCT00100789 · OUTCOME

Response

S0329, Gemcitabine and Paclitaxel in Treating Patients With Persistent, Recurrent, or Metastatic Head and Neck Cancer · Source last updated 2012-10-01

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
9 weeks - 3 years

What was measured

Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other normal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.

Analysis population: All eligible patients with measurable disease who started treatment were included in response measures.

Groups in this outcome

Gemcitabine and Paclitaxel

Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.

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

Analysis denominator · Participants

GroupSource count
Gemcitabine and Paclitaxel57

Reported measurements

Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel6Not reportedNot reportedNot reportedNot reported
Unconfirmed Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel1Not reportedNot reportedNot reportedNot reported
Unconfirmed Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel8Not reportedNot reportedNot reportedNot reported
Stable/No Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel11Not reportedNot reportedNot reportedNot reported
Increasing Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel21Not reportedNot reportedNot reportedNot reported
Assessment Inadequate
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine and Paclitaxel9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Unconfirmed Complete Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Unconfirmed Partial Response
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Stable/No Response
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        21
    title
    Increasing Disease
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Assessment Inadequate
denoms
  1. counts
    1. group Id
      OG000
      value
      57
    units
    Participants
description
Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other normal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.
groups
  1. description
    Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.
    id
    OG000
    title
    Gemcitabine and Paclitaxel
param Type
NUMBER
population Description
All eligible patients with measurable disease who started treatment were included in response measures.
reporting Status
POSTED
time Frame
9 weeks - 3 years
title
Response
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice