Trial Outcomes & Findings for Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer (NCT NCT00851877)

Results Overview

Seven participants were assigned nab-paclitaxel in dose of 25mg/m\^2. Five participants were assigned nab-paclitaxel in dose of 20mg/m\^2.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

37 participants

Primary outcome timeframe

90 days

Results posted on

2020-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	Phase I Nab-paclitaxel 25 mg/m^2 Cetuximab 450mg/m\^2 as a loading dose in week one. Cetuximab 250 mg/m\^2, Cisplatin 20mg/m\^2 and nab-paclitaxel 25mg/m\^2 weekly, concurrent with 70 Gy in 35 fractions continuous course intensity modulated radiotherapy during weeks 2-8.	Phase I Nab-paclitaxel 20mg/m^2 Cetuximab 450mg/m\^2 as a loading dose in week one. Cetuximab 250 mg/m\^2, Cisplatin 20mg/m\^2 and nab-paclitaxel 20mg/m\^2 weekly, concurrent with 70 Gy in 35 fractions continuous course intensity modulated radiotherapy during weeks 2-8.	Phase II Nab-paclitaxel 20mg/m^2 Cetuximab 450mg/m\^2 as a loading dose in week one. Cetuximab 250 mg/m\^2, Cisplatin 20mg/m\^2 and nab-paclitaxel 20mg/m\^2 weekly, concurrent with 70 Gy in 35 fractions continuous course intensity modulated radiotherapy during weeks 2-8.
Phase I-1 STARTED	7	0	0
Phase I-1 COMPLETED	6	0	0
Phase I-1 NOT COMPLETED	1	0	0
Phase I-2 STARTED	0	5	0
Phase I-2 COMPLETED	0	5	0
Phase I-2 NOT COMPLETED	0	0	0
Phase II STARTED	0	0	25
Phase II COMPLETED	0	0	22
Phase II NOT COMPLETED	0	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I Nab-paclitaxel 25 mg/m^2 Cetuximab 450mg/m\^2 as a loading dose in week one. Cetuximab 250 mg/m\^2, Cisplatin 20mg/m\^2 and nab-paclitaxel 25mg/m\^2 weekly, concurrent with 70 Gy in 35 fractions continuous course intensity modulated radiotherapy during weeks 2-8.	Phase I Nab-paclitaxel 20mg/m^2 Cetuximab 450mg/m\^2 as a loading dose in week one. Cetuximab 250 mg/m\^2, Cisplatin 20mg/m\^2 and nab-paclitaxel 20mg/m\^2 weekly, concurrent with 70 Gy in 35 fractions continuous course intensity modulated radiotherapy during weeks 2-8.	Phase II Nab-paclitaxel 20mg/m^2 Cetuximab 450mg/m\^2 as a loading dose in week one. Cetuximab 250 mg/m\^2, Cisplatin 20mg/m\^2 and nab-paclitaxel 20mg/m\^2 weekly, concurrent with 70 Gy in 35 fractions continuous course intensity modulated radiotherapy during weeks 2-8.
Phase I-1 Death	1	0	0
Phase II Withdrawal by Subject	0	0	3

Baseline Characteristics

Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nab-Paclitaxel, Cisplatin, Cetuximab and Radiation Therapy n=34 Participants Phase I/II Cetuximab, Cisplatin and nab-paclitaxel concurrent with intensity-modulated radiotherapy.
Age, Continuous	55.5 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Population: 12 patients enrolled in the phase I study.

Seven participants were assigned nab-paclitaxel in dose of 25mg/m\^2. Five participants were assigned nab-paclitaxel in dose of 20mg/m\^2.

Outcome measures

Outcome measures
Measure	Phase I Nab-Paclitaxel, Cisplatin, Cetuximab and Radiotherapy n=12 Participants Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy Cetuximab: Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor Cisplatin: Cisplatin is an anti-cancer chemotherapy drug Nab-Paclitaxel: paclitaxel albumin-stabilized nanoparticle formulation intensity-modulated radiation therapy: intensity-modulated radiation therapy
Phase I Maximum Tolerated Dose of Nab-Paclitaxel	20 mg/m^2

PRIMARY outcome

Timeframe: 2 year

Population: 12 patients from Phase I also participated in Phase II of this study. 25 patients enrolled in the phase II study with 3 patients withdrew from the study prior to treatment.

Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The primary endpoint of 2-year progression-free survival was measured from the date of enrollment to the first occurrence of new metastatic lesion, objective tumor progression, or death.

Outcome measures

Outcome measures
Measure	Phase I Nab-Paclitaxel, Cisplatin, Cetuximab and Radiotherapy n=34 Participants Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy Cetuximab: Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor Cisplatin: Cisplatin is an anti-cancer chemotherapy drug Nab-Paclitaxel: paclitaxel albumin-stabilized nanoparticle formulation intensity-modulated radiation therapy: intensity-modulated radiation therapy
Phase II 2-year Progression-free Survival	60 percentage of participants Interval 42.0 to 78.0

SECONDARY outcome

Timeframe: 2 year

Population: 12 patients from Phase I also participated in Phase II of this study. 25 patients enrolled in the phase II study with 3 patients withdrew from the study prior to treatment.

Local control is defined as the arrest cancer growth at the site of origin. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions

Outcome measures

Outcome measures
Measure	Phase I Nab-Paclitaxel, Cisplatin, Cetuximab and Radiotherapy n=34 Participants Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy Cetuximab: Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor Cisplatin: Cisplatin is an anti-cancer chemotherapy drug Nab-Paclitaxel: paclitaxel albumin-stabilized nanoparticle formulation intensity-modulated radiation therapy: intensity-modulated radiation therapy
Phase II 2-year Local Control	71 percentage of participants Interval 55.0 to 87.0

SECONDARY outcome

Timeframe: 2 year

Population: 12 patients from Phase I also participated in Phase II of this study. 25 patients enrolled in the phase II study with 3 patients withdrew from the study prior to treatment.

median follow-up 24 months for 34 patients

Outcome measures

Outcome measures
Measure	Phase I Nab-Paclitaxel, Cisplatin, Cetuximab and Radiotherapy n=34 Participants Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy Cetuximab: Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor Cisplatin: Cisplatin is an anti-cancer chemotherapy drug Nab-Paclitaxel: paclitaxel albumin-stabilized nanoparticle formulation intensity-modulated radiation therapy: intensity-modulated radiation therapy
Phase II 2-year Overall Survival	68 percentage of participants Interval 50.0 to 86.0

Adverse Events

Nab-Paclitaxel, Cisplatin, Cetuximab and Radiation Therapy

Serious events: 3 serious events

Other events: 32 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Nab-Paclitaxel, Cisplatin, Cetuximab and Radiation Therapy n=34 participants at risk Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy Cetuximab: Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor Cisplatin: Cisplatin is an anti-cancer chemotherapy drug Nab-Paclitaxel: paclitaxel albumin-stabilized nanoparticle formulation intensity-modulated radiation therapy: intensity-modulated radiation therapy
Blood and lymphatic system disorders Nab-Paclitaxel toxicity	8.3% 1/12 • Number of events 1 • Through study completion, and average of 2 years.
General disorders grade 4 larynx edema	5.9% 2/34 • Number of events 2 • Through study completion, and average of 2 years.

Other adverse events

Other adverse events
Measure	Nab-Paclitaxel, Cisplatin, Cetuximab and Radiation Therapy n=34 participants at risk Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy Cetuximab: Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor Cisplatin: Cisplatin is an anti-cancer chemotherapy drug Nab-Paclitaxel: paclitaxel albumin-stabilized nanoparticle formulation intensity-modulated radiation therapy: intensity-modulated radiation therapy
Endocrine disorders hypothyroidism	20.6% 7/34 • Number of events 7 • Through study completion, and average of 2 years.
General disorders larynx edema	44.1% 15/34 • Number of events 15 • Through study completion, and average of 2 years.
General disorders xerostomia	29.4% 10/34 • Number of events 10 • Through study completion, and average of 2 years.
General disorders fibrosis	11.8% 4/34 • Number of events 4 • Through study completion, and average of 2 years.

Additional Information

Director of Clinical Trial

UT Southwestern Medical Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place