Squamous Cell Carcinoma of Head and NeckPhase 2NCT00459043
Docetaxel in Combination With Zactima (ZD6474) in Patients With Locally Advanced Squamous Cell Carcinoma of the the Head and Neck
A Phase 2 study testing ZD6474 and Docetaxel in people with Squamous Cell Carcinoma of Head and Neck, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- ZD6474 and Docetaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2007to Feb 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically/cytologically documented SCCHN, excluding nasopharyngeal carcinoma. Squamous cell carcinomas of unknown primary are allowed. Primary salivary gland tumors and tumor of the nasal cavity and paranasal sinuses are not included.
- 18 years of age or older.
- Evaluable or uni-dimensionally measurable local-regional and/or metastatic disease that is not amendable to primary surgical resection or radiotherapy.
- Life expectancy of at least 3 months.
- ECOG performance status of 0-2.
- Negative pregnancy test for women of childbearing potential.
- Adequate bone marrow function.
Who cannot join
- Evidence of sever or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial.
- Clinically significant cardiac event such as myocardial infarction, NYHA classification of heart disease grade II or higher within 3 months of study entry, or presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.
- History of arrhythmia which is symptomatic or requires treatment or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded.
- Previous history of QTc prolongation as a result from other medication that required discontinuation of that medication.
- Congenital long QT syndrome, or 1st degree relative with unexplained sudden death under 40 years of age.
- Presence of left bundle branch block.
Show all 17Show fewer
- QTc with Bazett's correction that is unmeasurable or > 480 msec on screening ECG.
- Any concomitant medication that may cause QTC prolongation, induce Torsades de Pointes or induce CYP3A4 function.
- Hypertension not controlled by medical therapy.
- Currently active diarrhea that may affect the ability of the patient to absorb Zactima.
- Pregnant or breast-feeding women.
- Previous or concurrent malignancies of other histologies within the last 5 years, with the exception of cervical carcinoma in-situ and adequately treated basal cell or squamous cell carcinoma of the skin.
- Receipt of any investigational agents within 30 days prior to commencing study treatment.
- Prior treatment with docetaxel.
- Last dose of prior chemotherapy discontinued less than 3 weeks before start of study therapy.
- Last dose of radiation therapy within the last 4 weeks before the start of study therapy, except palliative radiotherapy.
- Major surgery within 4 weeks, or incompletely healed surgical incision.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Loyola University Medical Center/Cardinal Bernadin Cancer Center
Maywood, Illinois, 60153
About this study
Official title: Randomized Phase II Study of Docetaxel in Combination With Zactima (ZD6474) in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
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.
Read the detailed description
- Participants will be "randomized" into one of the following study groups: Docetaxel or Docetaxel with Zactima. Randomization means that participants will be put into a group by chance.
- The Docetaxel group will receive docetaxel on the first day of every treatment cycle, which lasts for 3 weeks. Even though treatment will occur once every three weeks, participants will return to the clinic on a weekly basis for the first two cycles. After the first two cycles, they will only have to return to the clinic at the start of each cycle.
- The combination Docetaxel and Zactima group will also receive docetaxel once every three weeks. In addition to the docetaxel, they will also take a Zactima pill orally every morning. They will also have to return to the clinic on a weekly basis just as those in the docetaxel only group.
- The following tests and procedures will be performed during each cycle of treatment, regardless of which group the participant is randomized into. These are considered standard of care for treating patients with chemotherapy for recurrent head and neck cancer: physical exams; blood tests; urine test; nasopharyngoscopy; repeat imaging of the tumor (x-ray, CT, MRI or PET); photographs of the tumor. In addition to the tests mentioned above, the Zactima group will have EKGs performed 3 times on the first day of treatment, once at week 2, then at the beginning of cycles 2 and 3, and then every 6 weeks.
- Participants will continue on the study as long as they are receiving benefit and are not experiencing any unmanageable side effects.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- ZD6474, Docetaxel
- Keywords
- SCCHN
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD6474Drug
Also called Zactima
Taken orally once every morning
DocetaxelDrug
Given on the first day of every treatment cycle (every 3 weeks)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Docetaxel Alone Receives: Drug: Docetaxel |
| 2 | Active comparator | Docetaxel with ZD6474 Receives: Drug: ZD6474; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (2)
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
Measured: 3 years
Overall Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2010
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital, Loyola University, AstraZeneca
- Responsible party
- Principal investigator, Robert I. Haddad, MD, Dana-Farber Cancer Institute
- Investigators
- Robert Haddad, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459043
- Sponsor's protocol ID
- 06-283
- Status last verified
- Jul 2013
- First submitted
- 10 Apr 2007
- Last updated
- 3 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Docetaxel in Combination With Zactima (ZD6474) in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT00459043
- Acronym / sponsor ID
- 06-283
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Keywords
- SCCHN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Massachusetts General Hospital, Loyola University, AstraZeneca
- Study start
- Mar 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 11 Apr 2007 (estimated)
- Results
- Posted 3 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Participants will be "randomized" into one of the following study groups: Docetaxel or Docetaxel with Zactima. Randomization means that participants will be put into a group by chance.
- The Docetaxel group will receive docetaxel on the first day of every treatment cycle, which lasts for 3 weeks. Even though treatment will occur once every three weeks, participants will return to the clinic on a weekly basis for the first two cycles. After the first two cycles, they will only have to return to the clinic at the start of each cycle.
- The combination Docetaxel and Zactima group will also receive docetaxel once every three weeks. In addition to the docetaxel, they will also take a Zactima pill orally every morning. They will also have to return to the clinic on a weekly basis just as those in the docetaxel only group.
- The following tests and procedures will be performed during each cycle of treatment, regardless of which group the participant is randomized into. These are considered standard of care for treating patients with chemotherapy for recurrent head and neck cancer: physical exams; blood tests; urine test; nasopharyngoscopy; repeat imaging of the tumor (x-ray, CT, MRI or PET); photographs of the tumor. In addition to the tests mentioned above, the Zactima group will have EKGs performed 3 times on the first day of treatment, once at week 2, then at the beginning of cycles 2 and 3, and then every 6 weeks.
- Participants will continue on the study as long as they are receiving benefit and are not experiencing any unmanageable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: DocetaxelDocetaxel Alone |
| 2 | Active comparator | Drug: ZD6474, Drug: DocetaxelDocetaxel with ZD6474 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically/cytologically documented SCCHN, excluding nasopharyngeal carcinoma. Squamous cell carcinomas of unknown primary are allowed. Primary salivary gland tumors and tumor of the nasal cavity and paranasal sinuses are not included.
- 18 years of age or older.
- Evaluable or uni-dimensionally measurable local-regional and/or metastatic disease that is not amendable to primary surgical resection or radiotherapy.
- Life expectancy of at least 3 months.
- ECOG performance status of 0-2.
Key exclusion criteria (17 listed)
- Evidence of sever or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the trial.
- Clinically significant cardiac event such as myocardial infarction, NYHA classification of heart disease grade II or higher within 3 months of study entry, or presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.
- History of arrhythmia which is symptomatic or requires treatment or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded.
- Previous history of QTc prolongation as a result from other medication that required discontinuation of that medication.
- Congenital long QT syndrome, or 1st degree relative with unexplained sudden death under 40 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZD6474Also: ZactimaTaken orally once every morning | Drug | 2 |
| DocetaxelGiven on the first day of every treatment cycle (every 3 weeks) | Drug | 1, 2 |
Primary outcome
Partial Response Rate in Both Groups of Patients.
Time frame: 3 years
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
2 secondary outcomes
Progression Free Survival
Time frame: 3 years
Overall Survival
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Haddad, MD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZD6474 and Docetaxel in people with Squamous Cell Carcinoma of Head and Neck, run by Dana-Farber Cancer Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial Response Rate in Both Groups of Patients. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.