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

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Docetaxel; Gefitinib; Gemcitabine

Criteria

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