Gefitinib With or Without Carboplatin and Paclitaxel in Treating Older Patients With Unresectable or Metastatic Non-Small Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage IV non-small cell lung cancer, stage IIIB non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Metastatic or unresectable disease Measurable disease At least 1 lesion at least 2.0 cm Disease must be completely outside prior radiotherapy port OR documented disease progression since the completion of radiotherapy No meningeal carcinomatosis No untreated brain metastases Current metastatic CNS disease must have been treated and clinically stable for at least 2 weeks prior to study chemotherapy No potentially curative treatment options available (e.g., chemotherapy with surgery or radiotherapy) PATIENT CHARACTERISTICS: Age 65 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10.0 g/dL Hepatic Bilirubin no greater than 2.0 mg/dL No uncontrolled hepatic disease Renal Creatinine no greater than 2 times upper limit of normal No uncontrolled renal disease Cardiovascular No uncontrolled cardiac disease Pulmonary No clinically active interstitial lung disease Asymptomatic, chronic stable radiographic changes allowed No uncontrolled respiratory disease Other Fertile patients must use effective contraception Able and willing to complete questionnaires alone or with assistance No known hypersensitivity to gefitinib or any of its excipients No active infection within the past 2 weeks No other prior malignancy within the past 5 years except basal cell skin cancer No grade 2 or greater peripheral neuropathy (CTC v2.0) No uncontrolled diabetes mellitus (for patients receiving study chemotherapy) No dysphagia or inability to swallow intact capsules No significant medical condition that would preclude study treatment or follow-up No severe or uncontrolled systemic disease PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics No prior chemotherapy for metastatic NSCLC Endocrine therapy Concurrent steroids allowed provided the dose is not changed Radiotherapy See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 25% of marrow-containing skeleton No concurrent radiotherapy (including palliative) Surgery See Disease Characteristics At least 3 weeks since prior major surgery No surgery within 7 days after study participation Other More than 30 days since prior non-FDA approved investigational drugs No concurrent oral retinoids No concurrent CYP3A4-inducing agents, including the following: Carbamazepine Oxcarbazepine Modafinil Ethosuximide Griseofulvin Nafcillin Phenobarbital Phenylbutazone Phenytoin Primidone Rifampin Hypericum perforatum (St. John's wort) Barbiturates Sulfinpyrazone No concurrent drugs that cause sustained elevation of gastric pH (≥ 5) No concurrent antacids within 4 hours before, during, and within 4 hours after gefitinib administration No concurrent itraconazole, fluconazole, ketoconazole, or erythromycin
Sites / Locations
- Mayo Clinic Scottsdale
- Front Range Cancer Specialists
- Mayo Clinic - Jacksonville
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- St. Anthony's Memorial Hospital
- Eureka Community Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- Mason District Hospital
- Hopedale Medical Complex
- Joliet Oncology Hematology Associates, Limited - West
- Kewanee Hospital
- McDonough District Hospital
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology/Hematology Associates of Central Illinois, P.C.
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Saint Anthony Memorial Health Centers
- St. Luke's Hospital
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
- Siouxland Regional Cancer Center
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Cancer Center of Kansas, P.A. - Chanute
- Cancer Center of Kansas, P.A. - Dodge City
- Cancer Center of Kansas, P.A. - El Dorado
- Cancer Center of Kansas, P.A. - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, P.A. - Newton
- Cancer Center of Kansas, P.A. - Parsons
- Cancer Center of Kansas, P.A. - Pratt
- Cancer Center of Kansas, P.A. - Salina
- Cancer Center of Kansas, P.A. - Wellington
- Associates in Womens Health, P.A. - North Review
- Cancer Center of Kansas, P.A. - Medical Arts Tower
- Cancer Center of Kansas, P.A. - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, P.A. - Winfield
- Hickman Cancer Center at Bixby Medical Center
- Haematology-Oncology Associates of Ohio and Michigan, P.C.
- Community Cancer Center of Monroe
- Mercy Memorial Hospital System
- MeritCare Clinic - Bemidji
- Brainerd Medical Center
- St. Joseph's Medical Center
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- St. John's Hospital
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Chippewa County - Montevideo Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- Mayo Clinic Cancer Center
- Coborn Cancer Center
- CCOP - Metro-Minnesota
- Saint Francis Cancer Center
- St. Joseph's Hospital
- CentraCare Clinic - River Campus
- Park Nicollet Health Services
- Regions Hospital Cancer Care Center
- United Hospital
- Ridgeview Medical Center
- Woodwinds Health Campus
- Bismarck Cancer Center
- Cancer Care Center at Medcenter One Hospital
- Mid Dakota Clinic, P. C.
- St. Alexius Medical Center
- CCOP - MeritCare Hospital
- MeritCare Medical Group
- Altru Cancer Center at Altru Hospital
- Wood County Oncology Center
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- Veterans Affairs Medical Center - Dayton
- CCOP - Dayton
- Blanchard Valley Medical Associates
- Fremont Memorial Hospital
- Kenton Oncology, Incorporated
- Charles F. Kettering Memorial Hospital
- Lima Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- Middletown Regional Hospital
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- Firelands Regional Medical Center
- North Coast Cancer Care, Incorporated
- Promedica Cancer Center at Flower Hospital
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical College of Ohio Cancer Institute
- CCOP - Toledo Community Hospital
- Toledo Clinic, Incorporated - Main Clinic
- Toledo Surgical Specialists
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- Geisinger Medical Center
- Geisinger Medical Group
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- Avera McKennan Hospital and University Health Center
- Medical X-Ray Center, P. C.
- Sioux Valley Hospital and University of South Dakota Medical Center
- Franciscan Skemp Healthcare
- Allan Blair Cancer Centre at Pasqua Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
gefitinib
paclitaxel + carboplatin + gefitinib
Patients receive oral gefitinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and after the completion of course 2. Patients are followed every 3 months for 5 years.
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of chemotherapy and in the absence of disease progression, patients receive oral gefitinib as in group I. Quality of life is assessed at baseline and after the completion of course 2. Patients are followed every 3 months for 5 years.