Trial Outcomes & Findings for Cetuximab, Carboplatin, and Paclitaxel Followed by Radiation Therapy, With or Without Cisplatin, in Treating Patients With Metastatic Head and Neck Cancer (NCT NCT00301028)

NCT ID: NCT00301028

Last Updated: 2013-04-05

Results Overview

Number of participants with a complete response. Complete Response (CR): Disappearance of clinical and radiological evidence of tumor.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: Study period of 3 Years
• Results posted on: 2013-04-05

Participant Flow

Recruitment Period: January 31, 2005 to September 16, 2011

Of the forty-eight (48) participants registered, forty-seven (47) were eligible to participate in this trial

Participant milestones

Measure	Cetuximab + Carboplatin/Paclitaxel Cetuximab beginning weekly dose 400 mg/m\^2 intravenous (IV), and 250 mg/m\^2 weeks 2-6; Weekly Carboplatin Area Under the Curve (AUC) 2 and Paclitaxel 135 mg/m\^2 for 6 courses.
Overall Study STARTED	47
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cetuximab, Carboplatin, and Paclitaxel Followed by Radiation Therapy, With or Without Cisplatin, in Treating Patients With Metastatic Head and Neck Cancer

Baseline characteristics by cohort

Measure	Cetuximab + Carboplatin/Paclitaxel n=47 Participants Cetuximab beginning weekly dose 400 mg/m\^2 intravenous (IV), and 250 mg/m\^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m\^2 for 6 courses.
Age Continuous	53 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants

PRIMARY outcome

Timeframe: Study period of 3 Years

Number of participants with a complete response. Complete Response (CR): Disappearance of clinical and radiological evidence of tumor.

Outcome measures

Measure	Cetuximab + Carboplatin/Paclitaxel n=47 Participants Cetuximab beginning weekly dose 400 mg/m\^2 intravenous (IV), and 250 mg/m\^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m\^2 for 6 courses.
Number of Participants With Complete Response	39 participants

Adverse Events

Cetuximab + Carboplatin/Paclitaxel

Serious events: 37 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cetuximab + Carboplatin/Paclitaxel n=47 participants at risk Cetuximab beginning weekly dose 400 mg/m\^2 intravenous (IV), and 250 mg/m\^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m\^2 for 6 courses.
Psychiatric disorders Anorexia	8.5% 4/47 • 6 years
Blood and lymphatic system disorders Neutropenia	23.4% 11/47 • 6 years
Gastrointestinal disorders Mucositis	78.7% 37/47 • 6 years
General disorders Fatigue	6.4% 3/47 • 6 years
Skin and subcutaneous tissue disorders Rash/folliculitis	44.7% 21/47 • 6 years
Nervous system disorders Sensory neuropathy	2.1% 1/47 • 6 years
Investigations Allergic reaction	4.3% 2/47 • 6 years
General disorders Dry mouth	4.3% 2/47 • 6 years
General disorders Taste alteration	4.3% 2/47 • 6 years
Gastrointestinal disorders Dehydration	6.4% 3/47 • 6 years
Gastrointestinal disorders Nausea/vomiting	6.4% 3/47 • 6 years
Gastrointestinal disorders Diarrhea	8.5% 4/47 • 6 years
Blood and lymphatic system disorders Febrile neutropenia	2.1% 1/47 • 6 years

Other adverse events

Measure	Cetuximab + Carboplatin/Paclitaxel n=47 participants at risk Cetuximab beginning weekly dose 400 mg/m\^2 intravenous (IV), and 250 mg/m\^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m\^2 for 6 courses.
General disorders Arthralgia/myalgia	12.8% 6/47 • 6 years
Psychiatric disorders Anorexia	8.5% 4/47 • 6 years
Gastrointestinal disorders Diarrhea	8.5% 4/47 • 6 years
General disorders Fatigue	40.4% 19/47 • 6 years
Gastrointestinal disorders Nausea/vomiting	12.8% 6/47 • 6 years
Skin and subcutaneous tissue disorders Pruritus	6.4% 3/47 • 6 years
Skin and subcutaneous tissue disorders Rash/folliculitis	12.8% 6/47 • 6 years
Nervous system disorders Sensory neuropathy	4.3% 2/47 • 6 years
Blood and lymphatic system disorders Neutropenia	23.4% 11/47 • 6 years
Blood and lymphatic system disorders Anemia	8.5% 4/47 • 6 years
General disorders Dry mouth	29.8% 14/47 • 6 years
General disorders Taste alteration	31.9% 15/47 • 6 years
Gastrointestinal disorders Mucositis	14.9% 7/47 • 6 years
Skin and subcutaneous tissue disorders Rash/desquamation	12.8% 6/47 • 6 years
Ear and labyrinth disorders Tinnitus	6.4% 3/47 • 6 years

Additional Information

Merrill S. Kies, MD / Professor

UT MD Anderson Cancer Center

Email: CR_Study_Registration@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place