Trial Outcomes & Findings for Study of Albumin Bound-Paclitaxel for Treatment of Recurrent or Metastatic Head and Neck Cancer With Cetuximab (NCT NCT00319839)

NCT ID: NCT00319839

Last Updated: 2018-01-12

Results Overview

To assess the overall response rate (complete and partial response) to Abraxane in patients with recurrent or metastatic head and neck cancer.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

3 years

Results posted on

2018-01-12

Participant Flow

Study start date: March 2006 Primary completion date: May 2009 Study completion date: June 2010

Participant milestones

Participant milestones
Measure	Abraxane Plus Cetuximab Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.
Overall Study STARTED	7
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Abraxane Plus Cetuximab Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.
Overall Study Adverse Event	5
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Study of Albumin Bound-Paclitaxel for Treatment of Recurrent or Metastatic Head and Neck Cancer With Cetuximab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abraxane Plus Cetuximab n=7 Participants Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=93 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	6 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	7 participants n=93 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Analysis was not completed as the study was terminated early due to low accrual and of the 7 subjects who went on study, only 1 completed treatment.

To assess the overall response rate (complete and partial response) to Abraxane in patients with recurrent or metastatic head and neck cancer.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Population: Analysis was not completed as the study was terminated early due to low accrual and of the 7 subjects who went on study, only 1 completed treatment.

To assess the frequency and severity of toxicities associated with this treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Outcome measures

Outcome data not reported

Adverse Events

Abraxane Plus Cetuximab

Serious events: 1 serious events

Other events: 2 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Abraxane Plus Cetuximab n=7 participants at risk Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.
General disorders Influenza Grade III	14.3% 1/7 • 2 years, 1 month

Other adverse events

Other adverse events
Measure	Abraxane Plus Cetuximab n=7 participants at risk Drug: Abraxane-260 mg/m2 IV over 30 minutes every 3 weeks. Drug: Cetuximab will be added to Abraxane if there is documented progression on single agent Abraxane. First dose: 400 mg/m2 IV over 120 minutes. Weekly: 250 mg/m2 IV over 60 minutes Days 8 and 15 of cycle 1 and days 1, 8, 15 of all subsequent cycles.
Gastrointestinal disorders Constipatoin	14.3% 1/7 • 2 years, 1 month
Respiratory, thoracic and mediastinal disorders Difficulty Breathing and Swallowing	14.3% 1/7 • 2 years, 1 month

Additional Information

Chao Family Comprehensive Cancer Center

University of California, Irvine

Phone: (877) 827-8839

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place