Gefitinib, Docetaxel, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

NCT00310154 | Completed Phase 1 FDA Drug

• 5 other identifiers: CDR0000466391P30CA012197CCCWFU-62202ZENECA-IRUSIRES0043CCCWFU-BG03-310
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gefitinib together with docetaxel and radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with gefitinib and radiation therapy in treating patients with stage III non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; adenosquamous cell lung cancer; bronchoalveolar cell lung cancer; large cell lung cancer; squamous cell lung cancer; adenocarcinoma of the lung

Outcome Measures

Primary Outcomes (1)

• To determine the feasability of daily ZD1839 delivered with concurrent 3-dimensional planned thoracic radiation

  baseline to 2 months

Interventions

docetaxel DRUG

gefitinib DRUG

laboratory biomarker analysis OTHER

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following: * Squamous cell carcinoma * Adenocarcinoma (including bronchoalveolar cell) * Large cell anaplastic carcinoma (including giant and clear cell carcinomas) * Stage IIIA/B disease * Unresectable disease * Tumors adjacent to a vertebral body allowed * No demonstrable bone invasion * All gross disease must be able to be encompassed in the radiation boost field in accordance with the homogeneity criteria * Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in the radiation boost field in accordance with the homogeneity criteria * No scalene, supraclavicular, or contralateral hilar node involvement * Pleural effusion allowed if it is transudate, cytologically negative, and non-bloody AND tumor can be encompassed within a reasonable field of radiotherapy * No exudative, bloody, or cytologically malignant effusions * Pleural effusion seen on chest CT scan but not on chest x-ray and too small to tap allowed * Measurable disease, defined as lesions that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan * No nonmeasurable disease, including any of the following: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Abdominal masses that are not confirmed and followed by imaging techniques * Cystic lesions * Tumor lesions situated in a previously irradiated area PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Granulocyte count ≥ 1,500/mm\^3 * Hemoglobin \> 8.0 g/dL * Platelet count ≥ 100,000/mm\^3 * Bilirubin \< 1.5 mg/dL * Creatinine \< 1.5 times upper limit of normal (ULN) * Meets 1 of the following criteria: * AST and ALT \< 2 times ULN * AST and ALT ≤ 2.5 times ULN AND alkaline phosphatase (AP) normal * AST and ALT normal AND AP ≤ 4 times ULN * FEV\_1 ≥ 1.2 L * No other currently active malignancy except nonmelanoma skin cancers * Patients are not considered to have another currently active malignancy if they have completed therapy for the other malignancy and are considered by their physician to be at \< 30% risk of relapse (i.e., after treatment for early-stage prostate cancer) * Not pregnant or nursing * Fertile patients must use effective contraception during and for 3 months after completing treatment * No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No known severe hypersensitivity to gefitinib or any of the excipients of this product * No evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) * No evidence of any other significant clinical disorder or laboratory finding that would limit compliance with study requirements * No evidence of clinically active interstitial lung disease (asymptomatic, chronic stable radiographic changes allowed) * No peripheral neuropathy ≥ grade 1 PRIOR CONCURRENT THERAPY: * At least 2 weeks since prior formal exploratory thoracotomy * No prior chemotherapy or radiotherapy for NSCLC * No prior epidermal growth factor-targeting drugs (i.e., gefitinib, erlotinib, or cetuximab) * No other investigational agent within 30 days of study entry * No concurrent phenytoin, carbamazepine, rifampicin, barbiturates, or Hypericum perforatum (St John's wort) * No other concurrent hormonal therapy or chemotherapy except for the following: * Steroids for adrenal failure, allergic reactions, or septic shock * Hormones for nondisease-related conditions (e.g., insulin for diabetes) * Glucocorticosteroids as anti-emetics

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1082, United States

Location

Related Publications (1)

• Center B, Petty WJ, Ayala D, Hinson WH, Lovato J, Capellari J, Oaks T, Miller AA, Blackstock AW. A phase I study of gefitinib with concurrent dose-escalated weekly docetaxel and conformal three-dimensional thoracic radiation followed by consolidative docetaxel and maintenance gefitinib for patients with stage III non-small cell lung cancer. J Thorac Oncol. 2010 Jan;5(1):69-74. doi: 10.1097/JTO.0b013e3181c59a0e.

  PMID: 20035186 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma, Bronchiolo-Alveolar; Adenocarcinoma of Lung

Interventions

Docetaxel; Gefitinib; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Arthur William Blackstock, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

• Antonius A. Miller, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: March 29, 2006
• First Posted: April 3, 2006
• Study Start: November 1, 2003
• Primary Completion: July 1, 2007
• Study Completion: August 1, 2010
• Last Updated: May 30, 2017

Record last verified: 2011-11

Locations

US (1)