Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer

NCT00062270 | Completed Phase 1 DMC

• 5 other identifiers: CDR0000304674UAB-0162UAB-F020730006ZENECA-ZD1839US-0207AVENTIS-GIA-12139
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Combining chemotherapy and radiation therapy with gefitinib before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase I/II trial to compare the effectiveness of neoadjuvant chemoradiotherapy with or without gefitinib in treating patients who are undergoing surgery for 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

Outcome Measures

Primary Outcomes (1)

• Determine the tolerability and toxicity of gefitinib in combination with chest radiotherapy in patients with stage IIIA or stage IIIB non-small cell lung cancer.

Interventions

cisplatin DRUG

docetaxel DRUG

gefitinib DRUG

gemcitabine hydrochloride DRUG

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 19 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 * Stage IIIA (T1-3, N2) * Positive (pathological) ipsilateral mediastinal node * Selective stage IIIB meeting all of the following criteria: * No pleural/pericardial effusion or superior vena cava syndrome * T4 due to invasion of carina, trachea, or mediastinal structures * Mediastinal N3 nodes (without supraclavicular or cervical adenopathy) * Proof of N2 or N3 status requires surgical staging of the mediastinum (mediastinoscopy, mediastinotomy, or exploration) * Expression of epidermal growth factor receptor (at least 1+) by immunohistochemistry * Measurable disease by contrast CT scan allowed * No bronchoalveolar cell carcinoma * No prior diagnosis of lung cancer PATIENT CHARACTERISTICS: Age * 19 and over Performance status * ECOG 0-1 (0-2 if albumin is at least 0.85 times lower limit of normal and weight loss within 3 months before diagnosis is no greater than 10%) Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 150,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin normal * AST and ALT no greater than 2.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN * Alkaline phosphatase between 1.5-2 times ULN requires a negative bone scan for metastatic bone disease Renal * Creatinine no greater than 1.4 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiac * No myocardial infarction within the past 3 months * No active angina * No unstable heart rhythms * No congestive heart failure Pulmonary * Post-resection predicted FEV\_1% greater than 35% * Predicted FEV\_1% is defined as FEV\_1% times percent perfusion to uninvolved lung from quantitative lung V/Q scan report Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 6 weeks after study treatment * No other uncontrolled medical illness * No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix * No grade 2 or greater peripheral neuropathy * No concurrent ocular inflammation or infection * No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No known severe hypersensitivity reaction to gefitinib or any of its excipients * No prior severe allergic reaction to platinum-containing compounds or mannitol PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent growth factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) during chemotherapy Chemotherapy * No prior chemotherapy for lung cancer Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy for lung cancer Surgery * Recovered from prior major surgery * No concurrent ophthalmic surgery Other * More than 30 days since prior unapproved or investigational drugs * No concurrent use of the following drugs: * Phenytoin * Carbamazepine * Barbiturates * Rifampin * Phenobarbital * Hypericum perforatum (St. John's Wort) * Warfarin * No concurrent retinoids

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Docetaxel; Gefitinib; Gemcitabine; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Combined Modality Therapy; Therapeutics

Study Officials

• Francisco Robert, MD, FACP

  University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2003
• First Posted: June 6, 2003
• Study Start: May 1, 2003
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2004
• Last Updated: October 8, 2015

Record last verified: 2015-09

Locations

US (1)