Gefitinib With or Without Carboplatin and Paclitaxel in Treating Older Patients With Unresectable or Metastatic Non-Small Cell Lung Cancer
- Registration Number
- NCT00062062
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of cancer cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib with carboplatin and paclitaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gefitinib alone or together with carboplatin and paclitaxel works in treating older patients with unresectable or metastatic non-small cell lung cancer.
- Detailed Description
OBJECTIVES:
Primary
* Determine the 6-month progression status of older patients with unresectable or metastatic non-small cell lung cancer treated with gefitinib alone or with carboplatin and paclitaxel.
Secondary
* Determine the response rate in patients treated with these regimens.
* Determine the quality of life of patients treated with these regimens.
* Determine whether serum-secreted or soluble epidermal growth factor receptor (EGFR) concentrations predict response in patients treated with these regimens.
* Correlate the presence of social support for these patients with toxicity and efficacy of these regimens.
* Determine whether social support for these patients differs according to gender.
* Determine the reasons an oncologist would choose a chemotherapy vs a nonchemotherapy regimen for these patients.
Tertiary
* Correlate EGFR signaling pathway markers, RNA expression profile, gene polymorphisms of prespecified germline and tumor genes, and plasma and urine proteomic patterns with response rate and time to progression of patients receiving treatment in group I.
OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2 treatment groups as determined by their treating physician.
* Group I: Patients receive oral gefitinib on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
* Group II: 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.
PROJECTED ACCRUAL: A total of 107 patients (51 for group I and 56 for group II) will be accrued for this study within 1.7 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description paclitaxel + carboplatin + gefitinib gefitinib 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. gefitinib 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. paclitaxel + carboplatin + gefitinib carboplatin 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. paclitaxel + carboplatin + gefitinib paclitaxel 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.
- Primary Outcome Measures
Name Time Method Progression status at 6 months at 6 months
- Secondary Outcome Measures
Name Time Method Confirmed response rate (complete or partial response) Up to 5 years Overall survival Up to 5 years Progression-free survival Up to 5 years Quality of life as assessed by the Lung Cancer Symptom scale Up to 5 years Social support measure as assessed by the Lubben Social Network scale Up to 5 years
Trial Locations
- Locations (138)
Promedica Cancer Center at Flower Hospital
🇺🇸Sylvania, Ohio, United States
Medical College of Ohio Cancer Institute
🇺🇸Toledo, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
Woodwinds Health Campus
🇺🇸Woodbury, Minnesota, United States
Mid Dakota Clinic, P. C.
🇺🇸Bismarck, North Dakota, United States
St. Alexius Medical Center
🇺🇸Bismarck, North Dakota, United States
Altru Cancer Center at Altru Hospital
🇺🇸Grand Forks, North Dakota, United States
Kenton Oncology, Incorporated
🇺🇸Kenton, Ohio, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Toledo Surgical Specialists
🇺🇸Toledo, Ohio, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Geisinger Medical Group
🇺🇸State College, Pennsylvania, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Meeker County Memorial Hospital
🇺🇸Lichfield, Minnesota, United States
Cancer Center of Kansas, P.A. - Newton
🇺🇸Newton, Kansas, United States
Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
MeritCare Clinic - Bemidji
🇺🇸Bemidji, Minnesota, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Franciscan Skemp Healthcare
🇺🇸La Crosse, Wisconsin, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Avera McKennan Hospital and University Health Center
🇺🇸Sioux Falls, South Dakota, United States
Mercy Memorial Hospital System
🇺🇸Monroe, Michigan, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
St. Anthony's Memorial Hospital
🇺🇸Effingham, Illinois, United States
Front Range Cancer Specialists
🇺🇸Fort Collins, Colorado, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Joliet Oncology Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Mercy Regional Cancer Center at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas, P.A. - Chanute
🇺🇸Chanute, Kansas, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas, P.A. - Dodge City
🇺🇸Dodge City, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, P.A. - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, P.A. - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, P.A. - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, P.A. - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas, P.A. - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, P.A. - Wellington
🇺🇸Wellington, Kansas, United States
Associates in Womens Health, P.A. - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Haematology-Oncology Associates of Ohio and Michigan, P.C.
🇺🇸Lambertville, Michigan, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Winfield
🇺🇸Winfield, Kansas, United States
Mercy and Unity Cancer Center at Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States
Brainerd Medical Center
🇺🇸Brainerd, Minnesota, United States
St. Joseph's Medical Center
🇺🇸Brainerd, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital
🇺🇸Fridley, Minnesota, United States
St. John's Hospital
🇺🇸Maplewood, Minnesota, United States
Hennepin County Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
Chippewa County - Montevideo Hospital
🇺🇸Montevideo, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
🇺🇸Robbinsdale, Minnesota, United States
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
Coborn Cancer Center
🇺🇸Saint Cloud, Minnesota, United States
St. Joseph's Hospital
🇺🇸St Paul, Minnesota, United States
CentraCare Clinic - River Campus
🇺🇸St. Cloud, Minnesota, United States
Park Nicollet Health Services
🇺🇸St. Louis Park, Minnesota, United States
Saint Francis Cancer Center
🇺🇸Shakopee, Minnesota, United States
Regions Hospital Cancer Care Center
🇺🇸St. Paul, Minnesota, United States
United Hospital
🇺🇸St. Paul, Minnesota, United States
MeritCare Medical Group
🇺🇸Fargo, North Dakota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
Bismarck Cancer Center
🇺🇸Bismarck, North Dakota, United States
Cancer Care Center at Medcenter One Hospital
🇺🇸Bismarck, North Dakota, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Firelands Regional Medical Center
🇺🇸Sandusky, Ohio, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
🇺🇸Wilkes-Barre, Pennsylvania, United States
Allan Blair Cancer Centre at Pasqua Hospital
🇨🇦Regina, Saskatchewan, Canada
Medical X-Ray Center, P. C.
🇺🇸Sioux Falls, South Dakota, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Oncology Hematology Associates of Central Illinois - Ottawa
🇺🇸Ottawa, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C.
🇺🇸Peoria, Illinois, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸West Des Moines, Iowa, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
Siouxland Regional Cancer Center
🇺🇸Sioux City, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Fremont Memorial Hospital
🇺🇸Fremont, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
Cancer Center of Kansas, P.A. - Wichita
🇺🇸Wichita, Kansas, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States