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Combination Chemotherapy With or Without Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Combination Chemotherapy With or Without Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy With or Without Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical research trials and Combination Chemotherapy With or Without Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Combination Chemotherapy With or Without Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer. Combination Chemotherapy With or Without Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy With or Without Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Combination Chemotherapy With or Without Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer  Combination Chemotherapy With or Without Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Combination Chemotherapy With or Without Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
For Condition: recurrent non-small cell lung cancer,stage 3B non-small cell lung cancer,stage 4 non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Genentech ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for cancer growth. Combining combination chemotherapy with erlotinib may kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without erlotinib in treating non-small cell lung cancer. PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of combining carboplatin and paclitaxel with or without erlotinib in treating patients who have stage IIIB or stage IV non-small cell lung cancer.
Details: OBJECTIVES: I. Compare the duration of survival of patients with chemotherapy naive stage IIIB or IV non-small cell lung cancer treated with paclitaxel and carboplatin with or without erlotinib (Tarceva). II. Compare the objective tumor response rate, duration of response, and time to disease progression in patients treated with these regimens. III. Compare the toxic effects of these regimens in this patient population. IV. Determine the pharmacokinetic profile of erlotinib in a large population of patients. PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (IIIB vs IV), weight loss during the previous 6 months, measurable disease (yes vs no), and participating center. Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1 and oral erlotinib (Tarceva) daily on days 1-21. Arm II: Patients receive paclitaxel and carboplatin as in arm I and oral placebo on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression before the sixth course discontinue chemotherapy but continue to receive erlotinib or placebo. PROJECTED ACCRUAL: A total of 1,050 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed stage IIIB or IV non-small cell lung cancer (NSCLC;) Unresectable, inoperable, locally advanced, recurrent, or metastatic disease - No evidence of small cell, carcinoid, or mixed small cell/non-small cell histology - No symptomatic or untreated brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent biologic therapy - Chemotherapy: No prior chemotherapy for NSCLC; At least 5 years since prior chemotherapy for other malignancies; No other concurrent chemotherapy - Endocrine therapy: No concurrent hormonal therapy - Radiotherapy: At least 3 weeks since prior radiotherapy; No concurrent radiotherapy - Surgery: No prior surgical procedures affecting absorption; At least 3 weeks since prior surgery - Other: No other concurrent experimental anticancer medications --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: At least 3 months - Hematopoietic: Granulocyte count greater than 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); ALT and AST less than 2.5 times ULN (no greater than 5 times ULN if due to liver metastases); Alkaline phosphatase less than 2.5 times ULN - Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min; No uncontrolled hypercalcemia (calcium greater than 11.5 mg/dL) - Cardiovascular: No uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within the past 6 months; No serious cardiac arrhythmia requiring medication; Chronic atrial arrhythmia (e.g., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No other malignancy within the past 3 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer; No unstable systemic disease, including active infection; No gastrointestinal tract disease resulting in inability to take oral medication or a requirement for intravenous alimentation; No history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would preclude study therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertMass, Study Chair, Genentech
Mid Cities Oncology
Bedford, Texas, 76022
United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, 94589
United States
Crozer-Chester Medical Center
Upland, Pennsylvania, 19013
United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, 92120
United States
Oncology Hematology Consultants
Sarasota, Florida, 34239
United States
Whittingham Cancer Center
Norwalk, Connecticut, 06856
United States
Arlington Cancer Center
Arlington, Texas, 76012
United States
Texas Oncology PA Cancer Care and Research Center
Waco, Texas, 76712
United States
Medical Oncology Care Associates
Orange, California, 92668
United States
Cedars-Sinai Comprehensive Cancer Center
Los Angeles, California, 90048
United States
Overlook Hospital
Summit, New Jersey, 07902-0220
United States
Office of Nashat Yousif Gabrail
Canton, Ohio, 44718
United States
Virginia Mason Medical Center
Seattle, Washington, 98111
United States
California Cancer Care, Inc.
Greenbrae, California, 94904
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Greater Baltimore Medical Center and Cancer Center
Baltimore, Maryland, 21204
United States
Office of John Ward McClean
Galesburg, Illinois, 61401
United States
Billings Oncology Associates
Billings, Montana, 59101
United States
Baptist Regional Cancer Institute - Jacksonville
Jacksonville, Florida, 32207
United States
Office of Wendy Breyer
American Fork, Utah, 84003
United States
Memphis Cancer Center
Memphis, Tennessee, 38119
United States
Rocky Mountain Cancer Centers
Thornton, Colorado, 80221
United States
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, 04074
United States
Oncology Hematology of Lehigh Valley, P.C.
Bethlehem, Pennsylvania, 18015
United States
Hope Center
Terre Haute, Indiana, 47809
United States
Monmouth Hematology-Oncology Associates, P.A.
West Long Branch, New Jersey, 07764
United States
Desert Hematology-Oncology Medical Group Inc
Rancho Mirage, California, 92270
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Great Falls Clinic
Great Falls, Montana, 59405
United States
IMPATH Predictive Oncology
Yakima, Washington, 98902
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
United States
West Clinic
Memphis, Tennessee, 38120
United States
Tyler Cancer Center
Tyler, Texas, 75702
United States
Southeast Florida Hematology-Oncology Group
Ft. Lauderdale, Florida, 33308
United States
Hematology/Oncology Associates
Jacksonville, Florida, 32216
United States
Veterans Affairs Medical Center - Northport
Northport, New York, 11768
United States
Hematology and Oncology of Northeast Georgia
Athens, Georgia, 30606
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Medical Oncology Associates of Wyoming Valley, P.C.
Kingston, Pennsylvania, 18704-5527
United States
Progressive Care, S.C.
Chicago, Illinois, 60631
United States
North Florida Hematology & Oncology Associates
Jacksonville, Florida, 32204
United States
Oncology-Hematology Group of South Florida
Miami, Florida, 33176
United States
Kaiser Permanente - Portland
Portland, Oregon, 97227
United States
CCOP - Greenville
Greenville, South Carolina, 29615
United States
Texas Oncology
Arlington, Texas, 76012
United States
Northern Arizona Hematology and Oncology Associates
Sedona, Arizona, 86336
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Office of Gregory I. Berk
New York City, New York, 10021
United States
N.W. Carolina Oncology & Hematology, P.A.
Hickory, North Carolina, 28603
United States
Rocky Mountain Cancer Center
Englewood, Colorado, 80110
United States
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah, 84124
United States
Rainier Oncology
Puyallup, Washington, 98372
United States
St. Joseph Oncology, Inc.
St. Joseph, Missouri, 64506
United States
Swedish Cancer Institute
Seattle, Washington, 98104
United States
St. Joseph Mercy Hospital
Pontiac, Michigan, 48341-2985
United States
Center for Hematology-Oncology
Boca Raton, Florida, 33486
United States
Florida Oncology Associates
Orange Park, Florida, 32073
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Willamette Valley Cancer Center
Springfield, Oregon, 97477
United States
Hematology/Oncology Associates
Port Saint Lucie, Florida, 34952
United States
Oregon Cancer Center
Portland, Oregon, 97201-3098
United States
Mountain States Tumor Institute
Boise, Idaho, 83712
United States
Nevada Cancer Center
Las Vegas, Nevada, 89109
United States
Georgia Oncology Partners
Tucker, Georgia, 30084
United States
Sarah Cannon-Minnie Pearl Cancer Center
Nashville, Tennessee, 37203
United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012
United States
East Bay Medical Oncology
Concord, California, 94520
United States
Kaiser Permanente Capital Area Medical Group-Kensington Facility
Kensington, Maryland, 20895
United States
HemOnCare, P.C.
Brooklyn, New York, 11235
United States
Gaston Hematology and Oncology
Gastonia, North Carolina, 28054
United States
Rochester General Hospital
Rochester, New York, 14621
United States
Piedmont Oncology Specialtist, II, PLLC
Charlotte, North Carolina, 28262
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
West Texas Cancer Center
Odessa, Texas, 79761
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
Albany Regional Cancer Center
Albany, New York, 12208
United States
Ocala Oncology Center
Ocala, Florida, 34474
United States
Oncology Associates of Bridgeport, P.C.
Trumbull, Connecticut, 06611
United States
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, 33428
United States
Midwest Hematology Oncology Consultants, Ltd.
St. Louis, Missouri, 63136
United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42102-9007
United States
Maryland Hematology/Oncology Associates
Baltimore, Maryland, 21236
United States
Hematology Oncology, P.C.
Stamford, Connecticut, 06902
United States
Office of Kenneth Nahum and Gregory Manzullo
Howell, New Jersey, 07731
United States
Lancaster Cancer Center
Lancaster, Pennsylvania, 17605
United States
Joe Arrington Cancer Center
Lubbock, Texas, 79410
United States
Family Cancer Center
Collierville, Tennessee, 38017
United States
Texas Oncology PA (TOPA) at Baylor-Sammons
Dallas, Texas, 75246
United States
Norton Healthcare Pavilion
Louisville, Kentucky, 40202
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Winship Cancer Institute
Atlanta, Georgia, 30322
United States
Buffalo Medical Group, P.C.
Williamsville, New York, 14221
United States
Cancer Care Associates
Tulsa, Oklahoma, 74136
United States
Texoma Cancer Center
Wichita Falls, Texas, 76310
United States
Holy Cross Hospital
Ft. Lauderdale, Florida, 33308
United States
Office of Dr. Girish Amin
Brick, New Jersey, 08724
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
Rocky Mountain Cancer Center
Colorado Springs, Colorado, 80909
United States
Florida Cancer Specialists
Ft. Myers, Florida, 33901
United States
Cancer Research of Long Island, Inc.
Great Neck, New York, 11022
United States
Texas Oncology, P.A.
Dallas, Texas, 75231
United States
Charleston Hematology-Oncology, P.A.
Charleston, South Carolina, 29403
United States
Medical Oncology and Hematology Associates
Des Moines, Iowa, 50314
United States
Medical Oncology Group
Gulfport, Mississippi, 39501
United States
Comprehensive Cancer Centers of the Desert
Palm Springs, California, 92262
United States
Watson Clinic
Lakeland, Florida, 33804-5000
United States
Asheville Hematology and Oncology Associates, P.A.
Asheville, North Carolina, 28801
United States
Pasco Pinellas Cancer Center
Tarpon Springs, Florida, 34689
United States
Carolina Cancer Center
Aiken, South Carolina, 29801
United States
Hematology Oncology Associates - Skokie
Skokie, Illinois, 60076
United States
Texas Oncology P.A.
Dallas, Texas, 75230-2503
United States
Hematology-Oncology Associates
Mount Holly, New Jersey, 08060
United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109
United States
San Antonio Tumor and Blood Clinic
San Antonio, Texas, 78205
United States
Western Washington Oncology, Inc.
Olympia, Washington, 98502
United States
Altoona Hospital
Altoona, Pennsylvania, 16601-4899
United States
Cooper Hospital/University Medical Center
Voorhees, New Jersey, 08043
United States
Huntington Medical Group, P.C.
Huntington, New York, 11746
United States
Methodist Cancer Center - Omaha
Omaha, Nebraska, 68114
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
North Idaho Cancer Center
Coeur D Alene, Idaho, 83814
United States
Mid-Ohio Oncology/Hematology, Inc. - North Office
Westerville, Ohio, 43081
United States
Additional Information:
Study ID Numbers: CDR0000069172; GENENTECH-OSI2298g,MSKCC-01122
Study Start Date: June 2001
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029016
Other Stage 3b Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy Followed by Radiation Therapy With or Without Paclitaxel in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
2. Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed
3. Suramin and Either Docetaxel or Gemcitabine in Treating Patients With Stage IIIB or Stage IV Platinum-Refractory Non-Small Cell Lung Cancer
4. R115777 in Treating Patients With Recurrent or Metastatic Non-small Cell Lung Cancer
5. Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
Related Studies:
Other stage 3B non-small cell lung cancer Clinical Trials
Other Washington Clinical Trials
Other Yakima Clinical Trials
Combination Chemotherapy With or Without Erlotinib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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