Trial Outcomes & Findings for Docetaxel in Combination With Zactima (ZD6474) in Patients With Locally Advanced Squamous Cell Carcinoma of the the Head and Neck (NCT NCT00459043)
NCT ID: NCT00459043
Last Updated: 2013-07-03
Results Overview
Objective tumor response was evaluated radiogically using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. For target lesions: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) \>= 30% decrease in the sum of the longest diamter of target lesions; Overall Response (OR) = CR+PR
COMPLETED
PHASE2
30 participants
3 years
2013-07-03
Participant Flow
From March 2007 to October 2009, 30 patients were enrolled from four different sites in United States.
Patients were randomized in a 1:1 ratio to receive docetaxel alone or docetaxel and vandetanib as combination therapy. No stratification at randomization was made for the study
Participant milestones
| Measure |
1Docetaxel Single Agent
Docetaxel 75 mg/m2 was administered every 21 days intravenously.
|
2 Combination Docetaxel and ZD6474
Docetaxel with ZD6474
Docetaxel 75 mg/m2 was administered every 21 days intravenously. ZD6474 (Vandetanib) at 100 mg was administered as a once daily tablet given orally.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
1Docetaxel Single Agent
Docetaxel 75 mg/m2 was administered every 21 days intravenously.
|
2 Combination Docetaxel and ZD6474
Docetaxel with ZD6474
Docetaxel 75 mg/m2 was administered every 21 days intravenously. ZD6474 (Vandetanib) at 100 mg was administered as a once daily tablet given orally.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Docetaxel in Combination With Zactima (ZD6474) in Patients With Locally Advanced Squamous Cell Carcinoma of the the Head and Neck
Baseline characteristics by cohort
| Measure |
Docetaxel Single Agent
n=14 Participants
|
Combination of Docetaxel and Zactima
n=15 Participants
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age Continuous
|
56 years
STANDARD_DEVIATION 42 • n=99 Participants
|
60 years
STANDARD_DEVIATION 35 • n=107 Participants
|
58 years
STANDARD_DEVIATION 46 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
15 participants
n=107 Participants
|
29 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: 29 patients were analyzable
Objective tumor response was evaluated radiogically using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. For target lesions: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) \>= 30% decrease in the sum of the longest diamter of target lesions; Overall Response (OR) = CR+PR
Outcome measures
| Measure |
1Docetaxel Single Agent
n=14 Participants
Docetaxel Alone
|
2 Combination Docetaxel and ZD6474
n=15 Participants
Docetaxel with ZD6474
|
|---|---|---|
|
Partial Response Rate in Both Groups of Patients.
|
7 percentage of participants
Interval 0.2 to 33.8
|
13 percentage of participants
Interval 1.6 to 40.4
|
SECONDARY outcome
Timeframe: 3 yearsProgression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sumof the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions
Outcome measures
| Measure |
1Docetaxel Single Agent
n=14 Participants
Docetaxel Alone
|
2 Combination Docetaxel and ZD6474
n=15 Participants
Docetaxel with ZD6474
|
|---|---|---|
|
Progression Free Survival
|
3.21 weeks
Interval 3.0 to 22.0
|
9 weeks
Interval 5.86 to 18.1
|
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
1Docetaxel Single Agent
n=14 Participants
Docetaxel Alone
|
2 Combination Docetaxel and ZD6474
n=15 Participants
Docetaxel with ZD6474
|
|---|---|---|
|
Overall Survival
|
26.8 weeks
Interval 17.7 to 100.7
|
24.1 weeks
Interval 16.4 to 171.1
|
Adverse Events
1Docetaxel Single Agent
2 Combination Docetaxel and ZD6474
Serious adverse events
| Measure |
1Docetaxel Single Agent
n=14 participants at risk
Docetaxel Alone
|
2 Combination Docetaxel and ZD6474
n=15 participants at risk
Docetaxel with ZD6474
|
|---|---|---|
|
Blood and lymphatic system disorders
Hemorrhage
|
7.1%
1/14 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
Other adverse events
| Measure |
1Docetaxel Single Agent
n=14 participants at risk
Docetaxel Alone
|
2 Combination Docetaxel and ZD6474
n=15 participants at risk
Docetaxel with ZD6474
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutrophils
|
50.0%
7/14
|
40.0%
6/15
|
|
Gastrointestinal disorders
Dysphagia
|
57.1%
8/14
|
53.3%
8/15
|
|
Gastrointestinal disorders
Constipation
|
42.9%
6/14
|
46.7%
7/15
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
2/14
|
53.3%
8/15
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
35.7%
5/14
|
46.7%
7/15
|
|
Blood and lymphatic system disorders
Hemoglobin
|
28.6%
4/14
|
46.7%
7/15
|
|
Blood and lymphatic system disorders
Hemorrhage
|
7.1%
1/14
|
40.0%
6/15
|
|
Gastrointestinal disorders
Mucositis/Stomatitis
|
28.6%
4/14
|
33.3%
5/15
|
|
Gastrointestinal disorders
Anorexia
|
14.3%
2/14
|
33.3%
5/15
|
|
General disorders
Pain
|
35.7%
5/14
|
13.3%
2/15
|
|
Psychiatric disorders
Depression
|
28.6%
4/14
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14
|
20.0%
3/15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place