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Docetaxel With or Without Gefitinib in Treating Patients With Metastatic or Locally Recurrent Head and Neck Cancer
This study is currently recruiting participants.
Verified by University of Medicine and Dentistry New Jersey, June 2008
Sponsors and Collaborators: University of Medicine and Dentistry New Jersey
Eastern Cooperative Oncology Group
Information provided by: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00695760
  Purpose

This purpose of this study is to compare the effects (good and bad) of chemotherapy (docetaxel) plus ZD1839 (Iressa, gefitinib) with docetaxel and placebo on the head and neck cancer to see which is better. No study has yet compared ZD1839 (Iressa, gefitinib) and docetaxel in head and neck cancer. It is possible that the addition of ZD1839 (Iressa, gefitinib) to docetaxel in head and neck cancers. It is possible that the addition of ZD1839 (Iressa, gefitinib) to docetaxel will be more effective than docetaxel alone.

"ZD1839 (Iressa, gefitinib) is a new investigational drug treatment that has been shown to slow or stop growth in tumors. In clinical trials, ZD1839 (Iressa, gefitinib) has been able to shrink head and neck cancer tumors but in a small percentage of patients. A clinical trial that compared ZD1839 (Iressa, gefitinib) with methotrexate, a standard chemotherapy in head and neck cancer, showed that ZD1839 (Iressa, gefitinib) was not better than methotrexate. However, it is possible that adding ZD1839 (Iressa, gefitinib) to chemotherapy drugs will benefit patients with head and neck cancer. ZD1839 (Iressa, gefitinib) works differently from the way chemotherapy drugs work. Chemotherapy usually targets the cell's DNA and may affect both normal and cancer cells. ZD1839 (Iressa, gefitinib) targets a protein that is on the outside of cancer cells. The protein helps cancer cells to spread and grow. ZD1839 (Iressa, gefitinib) attaches to this protein and "switches it off" so that the cancer cells stop growing."


Condition Intervention Phase
Head and Neck Cancer
Drug: docetaxel OR placebo
Drug: docetaxel OR gefitinib
Phase III

MedlinePlus related topics: Cancer Head and Neck Cancer
Drug Information available for: Docetaxel ZD1839
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Phase III Randomized, Placebo Controlled, Trial Of Docetaxel Versus Docetaxel Plus ZD1839 (Iressa, Gefitinib, NSC 715055) In Performance Status 2 Or Previously Treated Patients With Recurrent Or Metastatic Head And Neck Cancer

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Patients are followed every 3 months for 2 years and then every 6 months for 3 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: Patients are followed every 3 months for 2 years and then every 6 months for 3 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: August 2004
Estimated Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Active Comparator
Patients receive docetaxel IV over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.
Drug: docetaxel OR placebo
Docetaxel will be given IV over 30-60 minutes Placebo will be given orally
Arm II: Experimental
Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.
Drug: docetaxel OR gefitinib
Docetaxel will be given IV over 30-60 minutes Gefitinib will be given orally

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
  • Metastatic or locally recurrent disease
  • No histologic type WHO 2 or 3 nasopharyngeal carcinoma
  • Incurable by local therapies
  • Meets 1 of the following criteria:
  • ECOG 2 AND no prior chemotherapy for metastatic or locally recurrent head and neck cancer
  • ECOG 0-2 AND received prior chemotherapy (i.e., ≥ 1 prior chemotherapy regimen [without docetaxel]) for metastatic or locally recurrent disease OR received prior chemotherapy (without docetaxel) as part of a primary curative therapy within the past 6 months
  • Measurable or non-measurable disease
  • Disease within a previously irradiated field is considered measurable provided there is unequivocal disease progression or biopsy-proven residual carcinoma after radiotherapy
  • Persistent disease after radiotherapy must be biopsy-proven ≥ 8 weeks after completion of radiotherapy
  • No tumors that are unequivocally invading major vessels (e.g. carotid artery)
  • No tumor-related hemorrhagic events in the past 3 months that require major medical intervention (e.g., surgery or embolization)
  • No known brain metastasis

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • See Disease Characteristics

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL

Hepatic

  • Alkaline phosphatase AND AST or ALT meeting criteria for 1 of the following:
  • Alkaline phosphatase normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times UNL AND AST or ALT ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 5 times ULN and AST or ALT normal
  • Bilirubin normal
  • Renal
  • Creatinine < 2.0 mg/dL OR
  • Creatinine clearance > 60 mL/min

Cardiovascular

  • No uncontrolled hypertension
  • No unstable angina
  • No congestive heart failure
  • No serious arrhythmia requiring medication

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No hypercalcemia related to head and neck cancer
  • No peripheral neuropathy ≥ grade 2
  • No hypersensitivity to gefitinib or any of its excipients
  • No severe hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
  • No unstable systemic disease
  • No active infection
  • No significant traumatic injury within the past 3 weeks
  • No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
  • No other co-existing condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior monoclonal antibody ABX-EBX or monoclonal antibody MDX-447
  • No prior cetuximab
  • At least 2 weeks since prior biologic/targeted therapy
  • No concurrent immunotherapy
  • No concurrent colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])

Chemotherapy

  • See Disease Characteristics
  • Prior paclitaxel allowed provided there was no disease progression during treatment
  • At least 4 weeks since prior chemotherapy and recovered
  • No prior docetaxel
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent antitumor hormonal therapy
  • Concurrent contraceptives, replacement steroids, and dexamethasone allowed

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery

  • At least 3 weeks since prior major surgery and recovered

Other

  • See Disease Characteristics
  • No other prior systemic epidermal growth factor receptor inhibitors, including any of the following:
  • Gefitinib
  • Erlotinib
  • PKI166
  • CI-1033
  • EKB-569
  • No concurrent CYP3A4 inducers, including any of the following:
  • Phenytoin
  • Carbamazepine
  • Rifampin
  • Phenobarbital
  • Hypericum perforatum (St. John's wort)
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent proton pump inhibitors or H2 antagonists within 4 hours after gefitinib administration
  • No concurrent therapeutic anticoagulation
  • No other concurrent antitumor therapy
  • No other concurrent experimental medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00695760

Locations
United States, New Jersey
University of Medicine and Dentistry of New Jersey Recruiting
Newark, New Jersey, United States, 07101
Contact: Yasmeen S Barber, BA     973-972-7789     barberys@umdnj.edu    
Principal Investigator: Lillian Pliner, MD            
Sub-Investigator: Margarette R Bryan, MD            
Sub-Investigator: Meera Hameed, MD            
Sub-Investigator: Mark Levin, MD            
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Eastern Cooperative Oncology Group
  More Information

Responsible Party: University of Pittsburgh-Dept of Medicine-Hematology/Oncology AND Eastern Cooperative Oncology Group ( Athanassios Argiris, M.D., FACP, Study Chair )
Study ID Numbers: 0120050012
Study First Received: June 9, 2008
Last Updated: June 9, 2008
ClinicalTrials.gov Identifier: NCT00695760  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Docetaxel
Head and Neck Neoplasms
Gefitinib
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009