Trial Outcomes & Findings for Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer (NCT NCT00425750)

NCT ID: NCT00425750

Last Updated: 2011-11-16

Results Overview

Progressive disease (PD): \>=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): \>=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: 7.55 months (average duration, on study to off study)
• Results posted on: 2011-11-16

Participant Flow

This study was open to accrual from 8/25/2005 through 5/20/2008.

Twenty-seven patients consented, two of which were ineligible.

Participant milestones

Measure	Bortezomib; Docetaxel Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
Overall Study STARTED	25
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	25

Reasons for withdrawal

Measure	Bortezomib; Docetaxel Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
Overall Study Death	1
Overall Study Withdrawal by Subject	3
Overall Study Adverse Event	3
Overall Study Progression of disease	18

Baseline Characteristics

Bortezomib and Docetaxel in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Baseline characteristics by cohort

Measure	Bortezomib; Docetaxel n=25 Participants Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age Continuous	55 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 7.55 months (average duration, on study to off study)

Progressive disease (PD): >=20% increase in sum of longest diameter (LD) of target lesion(s), taking as reference smallest sum LD recorded since treatment started. Complete response (CR): disappearance of all target lesions. Partial response (PR): >=30% decrease in sum of LD of target lesion(s), taking as reference baseline sum LD. Stable disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD.

Outcome measures

Measure	Bortezomib; Docetaxel n=25 Participants Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
Patient Response to Treatment Partial Response	1 participants
Patient Response to Treatment Progressive Disease	10 participants
Patient Response to Treatment Stable Disease	10 participants
Patient Response to Treatment Not Evaluable	4 participants

SECONDARY outcome

Timeframe: 7.55 months (average duration, on study to off study)

Median survival time of patients, calculated as on-study date to date of death or off-study date (censored)

Outcome measures

Measure	Bortezomib; Docetaxel n=25 Participants Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
Overall Survival	5.13 Month Interval 3.71 to 9.76

SECONDARY outcome

Timeframe: 7.55 months (average duration, on study to off study)

Median duration of survival without disease progression, calculated as on-study date to date of progression or date of death (censored) or off-study date (censored)

Outcome measures

Measure	Bortezomib; Docetaxel n=25 Participants Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
Progression-free Survival	2.27 Month Interval 1.61 to 4.7

Adverse Events

Bortezomib; Docetaxel

Serious events: 11 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bortezomib; Docetaxel n=25 participants at risk Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
General disorders Death	8.0% 2/25 • Number of events 2
Gastrointestinal disorders Vomitting	8.0% 2/25 • Number of events 2
Metabolism and nutrition disorders Hypercalcemia	4.0% 1/25 • Number of events 1
Nervous system disorders Seizure	4.0% 1/25 • Number of events 1
Gastrointestinal disorders Diarrhea	4.0% 1/25 • Number of events 1
Gastrointestinal disorders Dry mouth	4.0% 1/25 • Number of events 1
Gastrointestinal disorders Mucositis	4.0% 1/25 • Number of events 1
Gastrointestinal disorders Nausea	4.0% 1/25 • Number of events 1
Gastrointestinal disorders Hemorrhage, GI	4.0% 1/25 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Barbara Murphy, M.D.

Vanderbilt-Ingram Cancer Center

Phone: 615-343-4677

Results disclosure agreements

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