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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Massachusetts General Hospital | OTHER |
| Loyola University | OTHER |
| AstraZeneca |
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In this research study, the researchers are comparing the combination of docetaxel and Zactima with docetaxel alone to see if the combination of the two drugs will be more effective than docetaxel alone. Zactima blocks the actions of three substances in the body: 1)vascular endothelial growth factor reception (VEGFR); 2)epidermal growth factor receptor (EGFR); and 3) rearranged during transfection (RET). VEGFR stimulates the growth of new blood vessels. When certain proteins bind to the VEGF receptor, a process begins to occur which allows new blood vessels to be made that provide blood to the cancer cells. Zactima is thought to block these proteins from binding to the VEGF receptor, which would then block the process that creates new blood vessels. EGFR controls how quickly cells grow and multiply. RET is thought to have a particularly significant role in the development and growth of squamous cell tumors. The actions of Zactima are very different from the way standard chemotherapy drugs work. Researchers believe that Zactima might have different side effects from other cancer treatments so another one of the purposes of this study is to assess the side effects caused by the drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Docetaxel Alone |
|
| 2 | Active Comparator | Docetaxel with ZD6474 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZD6474 | Drug | Taken orally once every morning |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Partial Response Rate in Both Groups of Patients. | 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 | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | 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 | 3 years |
| Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Haddad, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center/Cardinal Bernadin Cancer Center | Maywood | Illinois | 60153 | 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
From March 2007 to October 2009, 30 patients were enrolled from four different sites in United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1Docetaxel Single Agent | Docetaxel 75 mg/m2 was administered every 21 days intravenously. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| INDUSTRY |
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| Docetaxel | Drug | Given on the first day of every treatment cycle (every 3 weeks) |
|
| 3 years |
| Massachusetts General Hospital |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
One patient withdrew consent after being randomized to docetaxel alone arm and did not receive any treatment, therefore, 29 patients were analyzable.
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| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel Single Agent | |
| BG001 | Combination of Docetaxel and Zactima | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Partial Response Rate in Both Groups of Patients. | 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 | 29 patients were analyzable | Posted | Number | 95% Confidence Interval | percentage of participants | 3 years |
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|
| ||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | 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 | Posted | Median | 95% Confidence Interval | weeks | 3 years |
|
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Posted | Median | 95% Confidence Interval | weeks | 3 years |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1Docetaxel Single Agent | Docetaxel Alone | 1 | 14 | 14 | 14 | ||
| EG001 | 2 Combination Docetaxel and ZD6474 | Docetaxel with ZD6474 | 1 | 15 | 15 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage | Blood and lymphatic system disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutrophils | Blood and lymphatic system disorders |
| |||
| Dysphagia | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Alopecia | Skin and subcutaneous tissue disorders |
| |||
| Hemoglobin | Blood and lymphatic system disorders |
| |||
| Neutrophils | Blood and lymphatic system disorders |
| |||
| Hemorrhage | Blood and lymphatic system disorders |
| |||
| Mucositis/Stomatitis | Gastrointestinal disorders |
| |||
| Anorexia | Gastrointestinal disorders |
| |||
| Pain | General disorders |
| |||
| Depression | Psychiatric disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Haddad | DFCI | 6176326725 | robert_haddad@dfci.harvard.edu |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C452423 | vandetanib |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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| >=65 years |
|
| Male |
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