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Docetaxel in Combination With Zactima (ZD6474) in Patients With Locally Advanced Squamous Cell Carcinoma of the the Head and Neck

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ClinicalTrials.gov Identifier: NCT00459043
Recruitment Status : Completed
First Posted : April 11, 2007
Results First Posted : July 3, 2013
Last Update Posted : July 3, 2013
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Loyola University
AstraZeneca
Information provided by (Responsible Party):
Robert I. Haddad, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Squamous Cell Carcinoma of Head and Neck
Interventions Drug: ZD6474
Drug: Docetaxel
Enrollment 30
Recruitment Details From March 2007 to October 2009, 30 patients were enrolled from four different sites in United States.
Pre-assignment Details 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
Arm/Group Title 1Docetaxel Single Agent 2 Combination Docetaxel and ZD6474
Hide Arm/Group Description Docetaxel 75 mg/m2 was administered every 21 days intravenously.

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.

Period Title: Overall Study
Started 15 15
Completed 14 15
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Docetaxel Single Agent Combination of Docetaxel and Zactima Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 14 15 29
Hide Baseline Analysis Population Description
One patient withdrew consent after being randomized to docetaxel alone arm and did not receive any treatment, therefore, 29 patients were analyzable.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  71.4%
11
  73.3%
21
  72.4%
>=65 years
4
  28.6%
4
  26.7%
8
  27.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 15 participants 29 participants
56  (42) 60  (35) 58  (46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 29 participants
Female
4
  28.6%
1
   6.7%
5
  17.2%
Male
10
  71.4%
14
  93.3%
24
  82.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 15 participants 29 participants
14 15 29
1.Primary Outcome
Title Partial Response Rate in Both Groups of Patients.
Hide Description 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
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
29 patients were analyzable
Arm/Group Title 1Docetaxel Single Agent 2 Combination Docetaxel and ZD6474
Hide Arm/Group Description:
Docetaxel Alone
Docetaxel with ZD6474
Overall Number of Participants Analyzed 14 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7
(0.2 to 33.8)
13
(1.6 to 40.4)
2.Secondary Outcome
Title Progression Free Survival
Hide Description Progression 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
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1Docetaxel Single Agent 2 Combination Docetaxel and ZD6474
Hide Arm/Group Description:
Docetaxel Alone
Docetaxel with ZD6474
Overall Number of Participants Analyzed 14 15
Median (95% Confidence Interval)
Unit of Measure: weeks
3.21
(3.0 to 22.0)
9
(5.86 to 18.1)
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1Docetaxel Single Agent 2 Combination Docetaxel and ZD6474
Hide Arm/Group Description:
Docetaxel Alone
Docetaxel with ZD6474
Overall Number of Participants Analyzed 14 15
Median (95% Confidence Interval)
Unit of Measure: weeks
26.8
(17.7 to 100.7)
24.1
(16.4 to 171.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1Docetaxel Single Agent 2 Combination Docetaxel and ZD6474
Hide Arm/Group Description Docetaxel Alone Docetaxel with ZD6474
All-Cause Mortality
1Docetaxel Single Agent 2 Combination Docetaxel and ZD6474
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1Docetaxel Single Agent 2 Combination Docetaxel and ZD6474
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      1/15 (6.67%)    
Blood and lymphatic system disorders     
Hemorrhage  1/14 (7.14%)  1 1/15 (6.67%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1Docetaxel Single Agent 2 Combination Docetaxel and ZD6474
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/14 (100.00%)      15/15 (100.00%)    
Blood and lymphatic system disorders     
Neutrophils  11/14 (78.57%)  10/15 (66.67%) 
Hemoglobin  4/14 (28.57%)  7/15 (46.67%) 
Neutrophils  7/14 (50.00%)  6/15 (40.00%) 
Hemorrhage  1/14 (7.14%)  6/15 (40.00%) 
Gastrointestinal disorders     
Dysphagia  8/14 (57.14%)  8/15 (53.33%) 
Constipation  6/14 (42.86%)  7/15 (46.67%) 
Diarrhea  2/14 (14.29%)  8/15 (53.33%) 
Mucositis/Stomatitis  4/14 (28.57%)  5/15 (33.33%) 
Anorexia  2/14 (14.29%)  5/15 (33.33%) 
General disorders     
Pain  5/14 (35.71%)  2/15 (13.33%) 
Psychiatric disorders     
Depression  4/14 (28.57%)  0/15 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia  5/14 (35.71%)  7/15 (46.67%) 
Rash  1/14 (7.14%)  3/15 (20.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Haddad
Organization: DFCI
Phone: 6176326725
EMail: robert_haddad@dfci.harvard.edu
Layout table for additonal information
Responsible Party: Robert I. Haddad, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00459043     History of Changes
Other Study ID Numbers: 06-283
First Submitted: April 10, 2007
First Posted: April 11, 2007
Results First Submitted: February 28, 2013
Results First Posted: July 3, 2013
Last Update Posted: July 3, 2013