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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.
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 groups in NCT00459043
Study groupRoleWhat they receive
1Active comparatorDocetaxel Alone
Receives: Drug: Docetaxel
2Active comparatorDocetaxel with ZD6474
Receives: Drug: ZD6474; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. 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

  2. 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.

  1. First posted11 Apr 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionMar 2010
  4. Study completionFeb 2012

Resources

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)
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
Data monitoring committee
Yes

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?

On the ClinicalTrials.gov record for NCT00459043.

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.

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