Trial Outcomes & Findings for Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma (NCT NCT01794845)

Last Updated: 2017-05-11

Results Overview

ORR is defined as the rate of study participants achieving complete response (CR) or partial response (PR) to protocol therapy according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Up to 6 months from End of Treatment, about 9 months

Results posted on

2017-05-11

Participant Flow

Participant milestones

Participant milestones
Measure	Erbitux, Taxotere, LD Fractionated RT Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT): * Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere. * Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7. * Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Erbitux, Taxotere, LD Fractionated RT Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT): * Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere. * Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7. * Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erbitux, Taxotere, LD Fractionated RT n=5 Participants Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT): * Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere. * Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7. * Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
Age, Categorical <=18 years	0 Participants n=4 Participants • Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.
Age, Categorical Between 18 and 65 years	2 Participants n=4 Participants • Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.
Age, Categorical >=65 years	2 Participants n=4 Participants • Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.
Sex: Female, Male Female	0 Participants n=4 Participants • Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.
Sex: Female, Male Male	4 Participants n=4 Participants • Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.
Region of Enrollment United States	5 participants n=5 Participants
Site of Head and Neck Carcinoma Larynx	2 Participants n=4 Participants • Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.
Site of Head and Neck Carcinoma Floor of Mouth	1 Participants n=4 Participants • Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.
Site of Head and Neck Carcinoma Tonsil	1 Participants n=4 Participants • Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.
Surgery	1 Participants n=4 Participants • Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.
Chemotherapy	3 Participants n=4 Participants • Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.

PRIMARY outcome

Timeframe: Up to 6 months from End of Treatment, about 9 months

Population: Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.

Outcome measures

Outcome measures
Measure	Erbitux, Taxotere, LD Fractionated RT n=4 Participants Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT): * Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere. * Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7. * Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
Overall Response Rate (ORR) of Participants Overall Response (CR+PR), 1 month	50 percentage of participants
Overall Response Rate (ORR) of Participants Overall Response (CR+PR), 6 months	0 percentage of participants
Overall Response Rate (ORR) of Participants Complete Response (CR), 1 month	0 percentage of participants
Overall Response Rate (ORR) of Participants Complete Response (CR), 6 months	0 percentage of participants
Overall Response Rate (ORR) of Participants Partial Response (PR), 1 month	50 percentage of participants
Overall Response Rate (ORR) of Participants Partial Response (PR), 6 months	0 percentage of participants
Overall Response Rate (ORR) of Participants Stable Disease (SD), 1 month	25 percentage of participants
Overall Response Rate (ORR) of Participants Stable Disease (SD), 6 months	0 percentage of participants
Overall Response Rate (ORR) of Participants Progressive Disease (PD), 1 month	25 percentage of participants
Overall Response Rate (ORR) of Participants Progressive Disease (PD), 6 months	100 percentage of participants

SECONDARY outcome

Timeframe: Up to 6 years

Population: Data for 4 of 5 participants analyzed due to 1 subject withdrawing prior to receiving protocol therapy.

Assess the safety profile (acute and late toxicities) of the proposed treatment. Number of study participants experiencing treatment-related acute and late toxicity: * Acute toxicity is defined as toxicity occurring within 90 days of start of therapy. * Late/Long-term toxicity defined as toxicity occurring more than 90 days after start of therapy.

Outcome measures

Outcome measures
Measure	Erbitux, Taxotere, LD Fractionated RT n=4 Participants Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT): * Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere. * Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7. * Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
Number of Study Participants Experiencing Treatment-Related Toxicity Acute Toxicities	4 Participants
Number of Study Participants Experiencing Treatment-Related Toxicity Late Toxicities	0 Participants

SECONDARY outcome

Timeframe: Up to 6 years

Population: At the time of study termination in June 2016, 1 patient had already died, 1 patient had refused follow-up, 1 patient was lost to follow-up and 1 patient was alive with disease. Progression-free survival data were not analyzed due to an insufficient number of evaluable participants accrued and early study termination for lack of efficacy.

Progression-free survival (PFS) is defined of the length of time from the start date of treatment to the earliest documented occurrence of disease progression according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) criteria. In the absence of an event constituting failure, follow up time will be censored at the date of last disease assessment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Population: At the time of study termination in June 2016, 1 patient had already died, 1 patient had refused follow-up, 1 patient was lost to follow-up and 1 patient was alive with disease. Overall survival data were not analyzed due to an insufficient number of evaluable participants accrued and early study termination for lack of efficacy.

Overall survival (OS) is defined as the length of time from the start of treatment that study participants diagnosed with the disease are still alive. OS will be measured from the start date of treatment to the date of death or last contact (censored observations).

Outcome measures

Outcome data not reported

Adverse Events

Erbitux, Taxotere, LD Fractionated RT

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Erbitux, Taxotere, LD Fractionated RT n=4 participants at risk Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT): * Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere. * Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7. * Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
Vascular disorders Hematoma	25.0% 1/4 • Number of events 1

Other adverse events

Other adverse events
Measure	Erbitux, Taxotere, LD Fractionated RT n=4 participants at risk Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT): * Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere. * Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7. * Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
Blood and lymphatic system disorders Anemia	25.0% 1/4 • Number of events 2
Gastrointestinal disorders Constipation	25.0% 1/4 • Number of events 1
Gastrointestinal disorders Dehydration	25.0% 1/4 • Number of events 1
Injury, poisoning and procedural complications Dermatitis radiation	25.0% 1/4 • Number of events 1
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	50.0% 2/4 • Number of events 2
Skin and subcutaneous tissue disorders Dry skin	25.0% 1/4 • Number of events 2
Nervous system disorders Dysgeusia	25.0% 1/4 • Number of events 1
Gastrointestinal disorders Dysphagia	50.0% 2/4 • Number of events 2
Ear and labyrinth disorders Ear pain	25.0% 1/4 • Number of events 1
Metabolism and nutrition disorders Hyperkalemia	25.0% 1/4 • Number of events 4
Metabolism and nutrition disorders Hypermagnesemia	25.0% 1/4 • Number of events 1
Metabolism and nutrition disorders Hypoalbuminemia	25.0% 1/4 • Number of events 1
General disorders Insomnia	25.0% 1/4 • Number of events 1
Investigations Lymphocyte count decreased	25.0% 1/4 • Number of events 1
General disorders Pain	25.0% 1/4 • Number of events 2
Infections and infestations Paronychia	25.0% 1/4 • Number of events 1
Skin and subcutaneous tissue disorders Pruritus	25.0% 1/4 • Number of events 1
Skin and subcutaneous tissue disorders Rash acneiform	75.0% 3/4 • Number of events 7
Skin and subcutaneous tissue disorders Skin induration	25.0% 1/4 • Number of events 1

Additional Information

Matthew C. Abramowitz MD

University of Miami

Phone: 305-243-4319

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place