NCT01064479 · OUTCOME

Disease Control (CR + PR + Stable Disease [SD])

Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck · Source last updated 2024-07-16

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 5 years

What was measured

Complete Response (CR) + Partial Response (PR) + Stable disease

Groups in this outcome

Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)

Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.

Arm B (Combination Chemotherapy and Placebo)

Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.

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

Analysis denominator · Participants

Group	Source count
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)	60
Arm B (Combination Chemotherapy and Placebo)	59

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)	47	Not reported	Not reported	Not reported	Not reported
Arm B (Combination Chemotherapy and Placebo)	41	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
47
group Id
OG001
value
41

denoms

counts
group Id
OG000
value
60
group Id
OG001
value
59
units
Participants

description

Complete Response (CR) + Partial Response (PR) + Stable disease

groups

description
Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
id
OG000
title
Arm A (Combination Chemotherapy and Erlotinib Hydrochloride)
description
Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.
id
OG001
title
Arm B (Combination Chemotherapy and Placebo)

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

5 years

title

Disease Control (CR + PR + Stable Disease [SD])

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice