Cisplatin, Fluorouracil, Iressa, and Radiation Therapy Patients With Locally Advanced Head and Neck Cancer

NCT00352105 | Completed Phase 1 Results DMC

• 4 other identifiers: CCF5842P30CA043703CCF-5842ZENECA-1839/0235
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving cisplatin, fluorouracil, and gefitinib together with radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin, fluorouracil, and gefitinib together with hyperfractionated radiation therapy and to see how well they work in treating patients with locally advanced head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx

Outcome Measures

Primary Outcomes (2)

• Number of Patients Treated With ZD1839 With Chemotherapy and Hyperfractionated Radiation That Had a 1-year Survival

  To explore the activity of ZD1839 with chemotherapy and hyperfractionated radiation using 1-year survival

  at 1 year after start of treatment

• Number of Participants With No Distant Metastatic Disease at 1 Year

  1-year distant metastatic disease control in patients with locally advanced squamous cell head and neck cancer. Distant disease means that cancer came back in sites outside of the head and neck.

  1 year

Secondary Outcomes (4)

• Number of Participants With No Local Disease at 1 Year

  at 1 year after start of treatment

• Number of Patients With Greater Than or Equal to Mild (Grade 1) Toxicity

  at 1 year after start of treatment

• Number of Patients With a Complete Response Defined as Complete Disappearance of All Clinically Detectable Tumor.

  3 years

• Number of Participants Who Completed 2 Years of Therapy

  at 2 years after start of treatment

Study Arms (1)

Concurrent Chemotherapy and ZD1839

EXPERIMENTAL

Drug: cisplatin; Drug: fluorouracil; Drug: Iressa; Radiation: hyperfractionated radiation therapy

Interventions

cisplatin DRUG

20mg/m2/d IV continuous infusion x4 days

Also known as: CDDP

Concurrent Chemotherapy and ZD1839

fluorouracil DRUG

1000mg.m2/d IV continuous x 4 days

Also known as: 5FU

Concurrent Chemotherapy and ZD1839

Iressa DRUG

250mg/PO qd x 2 years

Also known as: ZD1839

Concurrent Chemotherapy and ZD1839

hyperfractionated radiation therapy RADIATION

120cGy bid

Concurrent Chemotherapy and ZD1839

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed primary\* squamous cell carcinoma of the head and neck region, excluding any of the following: * Nasopharynx * Paranasal sinuses * Salivary glands NOTE: \*Primary site must be identified * Locoregionally confined stage III or IV disease * No evidence of nodal disease below the clavicles * No distant hematogenous metastases (M0) PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * WBC \> 3,500/mm³ * Platelet count \> 100,000/mm³ * Creatinine ≤ 2.0 mg/dL * Alkaline phosphatase \< 2 times normal * AST \< 2 times normal * Bilirubin ≤ 2.0 mg/dL * Calcium normal * Not pregnant or nursing * Fertile patients must use effective contraception * Must not be a poor compliance risk for follow-up * No known severe hypersensitivity to gefitinib or any excipients of this drug * No evidence of clinically active interstitial lung disease * Patients with chronic, stable radiographic changes who are asymptomatic are eligible * No unstable or uncontrolled angina, clinically apparent jaundice, or active infection * No history of any other malignancy (except squamous cell or basal cell skin cancer or cervical carcinoma in situ) unless disease free for ≥ 5 years * No other severe, uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) PRIOR CONCURRENT THERAPY: * Recovered from prior oncologic or other major surgery * No prior definitive surgery, radiotherapy, chemotherapy, immunotherapy, or epidermal growth factor receptor inhibitors for head and neck cancer * No investigational drugs within the past 30 days * No concurrent CYP3A4 inducers, including any of the following: * Phenytoin * Carbamazepine * Rifampin * Phenobarbital * Hypericum perforatum (St. John's wort) * Concurrent surgery allowed provided gefitinib is not administered 2 weeks before and 2 weeks after surgery * No concurrent aminoglycoside antibiotics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• David Adelstein: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Fluorouracil; Gefitinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. David Adelstein
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

adelstd@ccf.org

216-444-9310

Study Officials

• David J. Adelstein, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: July 14, 2006
• Study Start: April 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: May 1, 2010
• Last Updated: November 5, 2012
• Results First Posted: March 1, 2012

Record last verified: 2012-11

Locations

US (1)