Trial Outcomes & Findings for Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck (GCC 0442) (NCT NCT00343083)

Results Overview

The local regional control rate was assessed 3 months post completion of radiation therapy based on either MRI or CT and clinical exam.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

3 months

Results posted on

2019-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	Cetuximab (ERBITUX) and Concurrent Carboplatin . Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy. Chemotherapy will be given every week for a total of 8 weeks. Paclitaxel will be given at a dose of 40 mg/m2 as a 1 hour infusion dose followed by cetuximab and then carboplatin AUC = 2/week. The initial dose of cetuximab is 400 mg/m2 IV on day 1, followed by weekly infusions at 250 mg/m2 IV.
Overall Study STARTED	43
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Cetuximab (ERBITUX) and Concurrent Carboplatin, Paclitaxel & Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck (GCC 0442)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cetuximab (ERBITUX) and Concurrent Carboplatin n=43 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=99 Participants
Age, Categorical >=65 years	8 Participants n=99 Participants
Sex: Female, Male Female	6 Participants n=99 Participants
Sex: Female, Male Male	37 Participants n=99 Participants
Region of Enrollment United States	43 participants n=99 Participants

PRIMARY outcome

Timeframe: 3 months

The local regional control rate was assessed 3 months post completion of radiation therapy based on either MRI or CT and clinical exam.

Outcome measures

Outcome measures
Measure	Concurrent Chemo Raditaion Wtih Cetuximab n=43 Participants The addition of CTX to weekly PC and daily RT.
The Primary Endpoint is the Local Regional Control Rate Assessed 3 Months Post Completion of Radiation Therapy.	43 participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Concurrent Chemo Raditaion Wtih Cetuximab n=43 Participants The addition of CTX to weekly PC and daily RT.
Local Regional Control at 2 Years	72 percentage of participants 38

SECONDARY outcome

Timeframe: 3 years (overall) 2 years disease-free

Outcome measures

Outcome measures
Measure	Concurrent Chemo Raditaion Wtih Cetuximab n=43 Participants The addition of CTX to weekly PC and daily RT.
Overall Survival and Disease-free Survival overall survival	59 percentage of participants 38
Overall Survival and Disease-free Survival disease-free survival	58 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Adding CTX to weekly PC and daily RT. CBC and Chemistry panel blood testing

Outcome measures

Outcome measures
Measure	Concurrent Chemo Raditaion Wtih Cetuximab n=43 Participants The addition of CTX to weekly PC and daily RT.
Pathological Response to Cetuximab	43 participants

SECONDARY outcome

Timeframe: 9 weeks

One of the more serious side effects of cetuximab therapy is the incidence of acne-like rash. This rash rarely leads to dose reductions or termination of therapy. It is generally reversible. Further severe infusion reactions include but are not limited to: fevers, chills, rigors, urticaria, pruritis, rash, hypotension, N/V, HA, bronchospasm, dyspnea, wheezing, angioedema, dizziness, anaphylaxis, and cardiac arrest. Therefore, pretreatment with diphenhydramine 30-60 min. before administration is standard of care. Other common side effects include photosensitivity, hypomagnesemia due to magnesium wasting, and less commonly pulmonary and cardiac toxicity.

Outcome measures

Outcome measures
Measure	Concurrent Chemo Raditaion Wtih Cetuximab n=43 Participants The addition of CTX to weekly PC and daily RT.
Percentage of Participants With Grade 3 Toxicities of Cetuximab mucositis	79 percentage of participants 43
Percentage of Participants With Grade 3 Toxicities of Cetuximab rash	9 percentage of participants
Percentage of Participants With Grade 3 Toxicities of Cetuximab leukopenia	19 percentage of participants
Percentage of Participants With Grade 3 Toxicities of Cetuximab neutropenia	19 percentage of participants
Percentage of Participants With Grade 3 Toxicities of Cetuximab RT dermatisis	16 percentage of participants

SECONDARY outcome

Timeframe: 3 months

What is the the complete response (CR) rate at the completion of therapy.

Outcome measures

Outcome measures
Measure	Concurrent Chemo Raditaion Wtih Cetuximab n=43 Participants The addition of CTX to weekly PC and daily RT.
Clinical Complete Response Rate of This Regimen in the Population	84 percentage of participants 38

Adverse Events

Cetuximab (ERBITUX) and Concurrent Carboplatin

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cetuximab (ERBITUX) and Concurrent Carboplatin n=43 participants at risk
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaphylactic reaction	7.0% 3/43 • Number of events 3

Other adverse events

Adverse event data not reported

Additional Information

Ritesh Kataria

University of Maryland Baltimore

Phone: 410-328-8018

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place