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

NCT00459043 | Completed Phase 2 Results DMC

• 1 other identifier: 06-283
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

SCCHN

Outcome Measures

Primary Outcomes (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

  3 years

Secondary Outcomes (2)

• Progression Free Survival

  3 years

• Overall Survival

  3 years

Study Arms (2)

1

ACTIVE COMPARATOR

Docetaxel Alone

Drug: Docetaxel

2

ACTIVE COMPARATOR

Docetaxel with ZD6474

Drug: ZD6474; Drug: Docetaxel

Interventions

ZD6474 DRUG

Taken orally once every morning

Also known as: Zactima

2

Docetaxel DRUG

Given on the first day of every treatment cycle (every 3 weeks)

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator
• Loyola University: collaborator
• AstraZeneca: collaborator

Study Sites (3)

Loyola University Medical Center/Cardinal Bernadin Cancer Center

Maywood, Illinois, 60153, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

vandetanib; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Robert Haddad
• Organization: DFCI

robert_haddad@dfci.harvard.edu

6176326725

Study Officials

• Robert Haddad, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncology

Study Record Dates

• First Submitted: April 10, 2007
• First Posted: April 11, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: February 1, 2012
• Last Updated: July 3, 2013
• Results First Posted: July 3, 2013

Record last verified: 2013-07

Locations

US (3)