Combination Chemotherapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
NCT ID: NCT00054392
Last Updated: 2013-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2001-09-30
2001-09-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.
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Detailed Description
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* Compare the overall survival of patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with gemcitabine and carboplatin vs gemcitabine and paclitaxel vs paclitaxel and carboplatin.
* Compare the overall response rate and time to progression in patients treated with these regimens.
* Compare the toxic effects of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss within the past 6 months (less than 5% vs at least 5%), disease stage (IIIB vs IV), and brain metastases (present vs absent). Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 15-30 minutes on day 1.
* Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and paclitaxel IV over 3 hours on day 1.
* Arm III: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1.
In all arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 6 weeks during study treatment, and then every 3 months until progressive disease is documented.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 1,134 patients (378 per treatment arm) will be accrued for this study within 2 years.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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carboplatin
gemcitabine hydrochloride
paclitaxel
Eligibility Criteria
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Inclusion Criteria
* Clinically documented recurrent disease after prior radiation or surgery
* Stage IV disease (distant metastases)
* Stage IIIB disease presenting with 1 of the following:
* Pleural or pericardial effusion by CT scan or chest x-ray
* Pleural implants documented pathologically or seen on CT scan or x-ray
* Measurable or evaluable disease
* No brain metastases unless clinically stable after surgery and/or radiotherapy
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 mg/dL
* AST less than 5 times upper limit of normal
Renal
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 40 mL/min
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No hypersensitivity to agents that contain Cremophor EL (polyoxyethylated castor oil)
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for advanced NSCLC
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* Recovered from prior radiotherapy
* No prior radiotherapy to the only site of measurable disease, unless the site had subsequent progression of disease documented by physical exam, radiography, or pathology
* No concurrent radiotherapy (except for brain metastases)
Surgery
* See Disease Characteristics
Other
* No concurrent aminoglycoside antibiotics
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fox Chase Cancer Center
OTHER
Principal Investigators
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Joseph A. Treat, MD
Role: STUDY_CHAIR
Fox Chase Cancer Center
Locations
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Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
New Hope Cancer and Research Institute - Pomona
Pomona, California, United States
Lawrence and Memorial Hospital
New London, Connecticut, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States
Cancer Center of Indiana
New Albany, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Annapolis Oncology Center
Annapolis, Maryland, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States
Fallon Clinic at Worcester Medical Center
Worcester, Massachusetts, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, United States
Howell Township, New Jersey, United States
Jersey Shore Cancer Center at Jersey Shore University Medical Center
Neptune City, New Jersey, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States
Mercer Bucks Oncology-Hematology
Trenton, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Cape Fear Valley Medical Center
Fayetteville, North Carolina, United States
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, United States
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Parma Community General Hospital
Parma, Ohio, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
Falling Spring Medical Associates
Chambersburg, Pennsylvania, United States
Hematology-Oncology Associates of Northeastern Pennsylvania
Dunmore, Pennsylvania, United States
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
Harrisburg, Pennsylvania, United States
Richard G. Laube Cancer Center at ACMH
Kittanning, Pennsylvania, United States
Lancaster Cancer Center
Lancaster, Pennsylvania, United States
Central Pennsylvania Hematology and Medical Oncology Associates, PC
Lemoyne, Pennsylvania, United States
Paoli Hematology-Oncology PC at Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
Drexel University College of Medicine - Center City Hahnemann Campus
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center CCOP Research Base
Philadelphia, Pennsylvania, United States
Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, United States
St. Joseph Medical Center
Reading, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States
Coastal Cancer Center - Myrtle Beach
Myrtle Beach, South Carolina, United States
Family Cancer Center, PLLC - Collierville
Collierville, Tennessee, United States
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
Knoxville, Tennessee, United States
University of Virginia Cancer Center at UV Health System
Charlottesville, Virginia, United States
David Lee Outpatient Cancer Center at Charleston Area Medical Center
Charleston, West Virginia, United States
Morgantown Internal Medicine Group, Incorporated
Morgantown, West Virginia, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States
Countries
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References
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Edelman MJ, Belani CP, Socinski MA, Ansari RH, Obasaju CK, Chen R, Monberg MJ, Treat J; Alpha Oncology Research Network. Outcomes associated with brain metastases in a three-arm phase III trial of gemcitabine-containing regimens versus paclitaxel plus carboplatin for advanced non-small cell lung cancer. J Thorac Oncol. 2010 Jan;5(1):110-6. doi: 10.1097/JTO.0b013e3181c59a3a.
Obasaju CK, Ansari RH, Socinski MA, Chen R, Monberg MJ, Catalano RB, Marinucci DM, Liles DK, Ribeiro MJ, Comis RL, Treat J; Alpha Oncology Research Network. A Comparison of white and African American outcomes from a three-arm, randomized, phase III multicenter trial of advanced or metastatic non-small cell lung cancer. J Thorac Oncol. 2010 Jul;5(7):993-1000. doi: 10.1097/jto.0b013e3181e29cf3.
Treat JA, Gonin R, Socinski MA, Edelman MJ, Catalano RB, Marinucci DM, Ansari R, Gillenwater HH, Rowland KM, Comis RL, Obasaju CK, Belani CP; Alpha Oncology Research Network. A randomized, phase III multicenter trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin in patients with advanced or metastatic non-small-cell lung cancer. Ann Oncol. 2010 Mar;21(3):540-547. doi: 10.1093/annonc/mdp352. Epub 2009 Oct 15.
Treat J, Edelman MJ, Belani CP, Socinski MA, Monberg MJ, Chen R, Obasaju CK; Alpha Oncology Research Network. A retrospective analysis of outcomes across histological subgroups in a three-arm phase III trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin for advanced non-small cell lung cancer. Lung Cancer. 2010 Dec;70(3):340-6. doi: 10.1016/j.lungcan.2010.02.011. Epub 2010 Mar 27.
Treat J, Belani CP, Edelman MJ, et al.: A randomized phase III trial of gemcitabine (G) in combination with carboplatin (C) or paclitaxel (P) versus paclitaxel plus carboplatin in advanced (Stage IIIB, IV) non-small cell lung cancer (NSCLC): update of the Alpha Oncology trial (A1-99002L). [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA7025, 627s, 2005.
Other Identifiers
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CDR0000270434
Identifier Type: REGISTRY
Identifier Source: secondary_id
ALPHA-A1-99002L
Identifier Type: -
Identifier Source: org_study_id
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