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NCT00939627 · OUTCOME

Best Response

Phase II Randomized Trial of the Combination of Cetuximab and Sorafenib or Single Agent Cetuximab · Source last updated 2026-03-10

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
On-treatment date to date of disease progression (assessed up to 3 years)

What was measured

Number of patients in each response category, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), \>=20% increase in sum of longest diameter (LD) of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD.

Analysis population: All patients with best overall response data. Patients are excluded if best overall response data is missing or if the patient is not evaluable for best overall response.

Groups in this outcome

Arm A - Cetuximab

Patients were to receive cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.

Arm B - Cetuximab and Sorafenib Tosylate

Patients received cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.

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

Analysis denominator · Participants

GroupSource count
Arm A - Cetuximab22
Arm B - Cetuximab and Sorafenib Tosylate20

Reported measurements

Patients with Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Cetuximab0Not reportedNot reportedNot reportedNot reported
Arm B - Cetuximab and Sorafenib Tosylate0Not reportedNot reportedNot reportedNot reported
Patients with Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Cetuximab1Not reportedNot reportedNot reportedNot reported
Arm B - Cetuximab and Sorafenib Tosylate2Not reportedNot reportedNot reportedNot reported
Patients with Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Cetuximab11Not reportedNot reportedNot reportedNot reported
Arm B - Cetuximab and Sorafenib Tosylate10Not reportedNot reportedNot reportedNot reported
Patients with Progressive Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Cetuximab9Not reportedNot reportedNot reportedNot reported
Arm B - Cetuximab and Sorafenib Tosylate8Not reportedNot reportedNot reportedNot reported
Patients Not Evaluable
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Cetuximab4Not reportedNot reportedNot reportedNot reported
Arm B - Cetuximab and Sorafenib Tosylate6Not reportedNot reportedNot reportedNot reported
Patients with Less Than Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Cetuximab1Not reportedNot reportedNot reportedNot reported
Arm B - Cetuximab and Sorafenib Tosylate0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Patients with Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
    title
    Patients with Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        10
    title
    Patients with Stable Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        8
    title
    Patients with Progressive Disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
    title
    Patients Not Evaluable
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    Patients with Less Than Partial Response
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      20
    units
    Participants
description
Number of patients in each response category, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details): complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), \>=20% increase in sum of longest diameter (LD) of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD.
groups
  1. description
    Patients were to receive cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
    id
    OG000
    title
    Arm A - Cetuximab
  2. description
    Patients received cetuximab 400 mg/m\^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
    id
    OG001
    title
    Arm B - Cetuximab and Sorafenib Tosylate
param Type
NUMBER
population Description
All patients with best overall response data. Patients are excluded if best overall response data is missing or if the patient is not evaluable for best overall response.
reporting Status
POSTED
time Frame
On-treatment date to date of disease progression (assessed up to 3 years)
title
Best Response
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice