Trial Outcomes & Findings for Nab-Paclitaxel, Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer (NCT NCT00833261)

Results Overview

The 2-year PFS was measured from the date of enrollment to the first occurrence of new metastatic lesions, objective tumor progression, or death. The combination of cisplatin and cetuximab concurrent with radiation therapy for head and neck cancer has shown to have a favorable PFS. Patients were followed until death or from 7.5 months to 63.6 months (median 25.6 months) in those alive at last evaluation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

2 year from the date of enrollment

Results posted on

2020-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm: Chemotherapy With Concurrent Radiation Therapy Nab-Paclitaxel, Cetuximab, Cisplatin, and Intensity-modulated radiation therapy (IMRT)
Overall Study STARTED	37
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm: Chemotherapy With Concurrent Radiation Therapy Nab-Paclitaxel, Cetuximab, Cisplatin, and Intensity-modulated radiation therapy (IMRT)
Overall Study Withdrawal by Subject	4

Baseline Characteristics

One patient receiving treatment did not complete the entire course of systemic therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm: Chemotherapy With Concurrent Radiation Therapy n=34 Participants Nab-Paclitaxel, Cetuximab, Cisplatin, and Intensity-modulated radiation therapy (IMRT)
Age, Continuous	55.5 years n=33 Participants • One patient receiving treatment did not complete the entire course of systemic therapy
Sex: Female, Male Female	12 Participants n=33 Participants • One patient receiving treatment did not complete the entire course of systemic therapy
Sex: Female, Male Male	21 Participants n=33 Participants • One patient receiving treatment did not complete the entire course of systemic therapy
Region of Enrollment United States	33 participants n=33 Participants • One patient receiving treatment did not complete the entire course of systemic therapy

PRIMARY outcome

Timeframe: 2 year from the date of enrollment

The 2-year PFS was measured from the date of enrollment to the first occurrence of new metastatic lesions, objective tumor progression, or death. The combination of cisplatin and cetuximab concurrent with radiation therapy for head and neck cancer has shown to have a favorable PFS. Patients were followed until death or from 7.5 months to 63.6 months (median 25.6 months) in those alive at last evaluation.

Outcome measures

Outcome measures
Measure	Single Arm: Chemotherapy With Concurrent Radiation Therapy n=33 Participants Nab-Paclitaxel, Cetuximab, Cisplatin, and Intensity-modulated radiation therapy (IMRT)
Progression Free Survival (PFS)	60 percentage of participants Interval 42.0 to 78.0

SECONDARY outcome

Timeframe: 6 months within the end of treatment

Incidence rate of acute and late toxicities of grade 3 or higher was measured after each treatment cycle was over. The most common late toxicities defined as toxicity occurring more than 90 days after treatment included laryngeal edema and xerostomia.

Outcome measures

Outcome measures
Measure	Single Arm: Chemotherapy With Concurrent Radiation Therapy n=33 Participants Nab-Paclitaxel, Cetuximab, Cisplatin, and Intensity-modulated radiation therapy (IMRT)
Number of Participants With Acute and Late Toxicities	21 Participants

Adverse Events

Single Arm: Chemotherapy With Concurrent Radiation Therapy

Serious events: 21 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm: Chemotherapy With Concurrent Radiation Therapy n=33 participants at risk Nab-Paclitaxel, Cetuximab, Cisplatin, and Intensity-modulated radiation therapy (IMRT)
Blood and lymphatic system disorders Lymphopenia	63.6% 21/33 • Number of events 21
Blood and lymphatic system disorders Leukopenia	9.1% 3/33 • Number of events 3
Blood and lymphatic system disorders Neutropenia	12.1% 4/33 • Number of events 4
Blood and lymphatic system disorders Anemia	9.1% 3/33 • Number of events 3
Infections and infestations Infection	21.2% 7/33 • Number of events 7
Injury, poisoning and procedural complications Dermatitis	18.2% 6/33 • Number of events 6

Other adverse events

Other adverse events
Measure	Single Arm: Chemotherapy With Concurrent Radiation Therapy n=33 participants at risk Nab-Paclitaxel, Cetuximab, Cisplatin, and Intensity-modulated radiation therapy (IMRT)
General disorders Anorexia	15.2% 5/33 • Number of events 5
General disorders pain	30.3% 10/33 • Number of events 10
Gastrointestinal disorders Dysphagia	24.2% 8/33 • Number of events 8
Blood and lymphatic system disorders Other electrolyte abnormalities	24.2% 8/33 • Number of events 8
General disorders Fatigue	9.1% 3/33 • Number of events 3
General disorders Hyponatremia	9.1% 3/33 • Number of events 3
Blood and lymphatic system disorders Hypophosphatemia	9.1% 3/33 • Number of events 3
Gastrointestinal disorders Mucositis	15.2% 5/33 • Number of events 5

Additional Information

Dr. Lucien Nedzi

UT Southwestern Medical Center

Phone: 214-645-7653

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place