A Randomized, Phase III Multicenter Trial Of Gemcitabine In Combination With Carboplatin Or Paclitaxel Plus Carboplatin In Patients With Metastatic (Stage IIIB, IV) Non-Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Randomized, Phase III Multicenter Trial Of Gemcitabine In Combination With Carboplatin Or Paclitaxel Plus Carboplatin In Patients With Metastatic (Stage IIIB, IV) Non-Small Cell Lung Cancer
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed non-small cell lung cancer (NSCLC) of 1 of the following
types:
- Squamous cell
- Adenocarcinoma
- Large cell anaplastic
- Bronchoalveolar
- Non-small cell carcinoma not otherwise specified NOTE: Mixed tumors are
categorized by the predominant cell type (tumors with small-cell anaplastic
elements are ineligible)
- Evidence of at least 1 of the following:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Survival
Safety Issue:
No
Principal Investigator
Joseph A. Treat, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000270434
NCT ID:
NCT00054392
Start Date:
September 2001
Completion Date:
Related Keywords:
- Lung Cancer
- adenosquamous cell lung cancer
- bronchoalveolar cell lung cancer
- large cell lung cancer
- recurrent non-small cell lung cancer
- squamous cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- adenocarcinoma of the lung
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia 30033 |
| Hahnemann University Hospital | Philadelphia, Pennsylvania 19102-1192 |
| Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield, Massachusetts 01199 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Drexel University College of Medicine - Center City Hahnemann Campus | Philadelphia, Pennsylvania 19102 |
| Gulf Coast Cancer Treatment Center | Panama City, Florida 32405-4587 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
| University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
| Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown, West Virginia 26506 |
| Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio 44710-1799 |
| Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington, New Jersey 08822 |
| Parma Community General Hospital | Parma, Ohio 44129 |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
| Cape Fear Valley Medical Center | Fayetteville, North Carolina 28302-2000 |
| Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| Lakeland Regional Cancer Center at Lakeland Regional Medical Center | Lakeland, Florida 33805 |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois 60426 |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
| Baptist Regional Cancer Center at Baptist Hospital of East Tennessee | Knoxville, Tennessee 37901 |
| Lawrence and Memorial Hospital | New London, Connecticut 06320 |
| Pottstown Memorial Regional Cancer Center | Pottstown, Pennsylvania 19464 |
| Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania 15212 |
| St. Joseph Medical Center | Reading, Pennsylvania 19604 |
| Greater Baltimore Medical Center Cancer Center | Baltimore, Maryland 21204 |
| Leo W. Jenkins Cancer Center at ECU Medical School | Greenville, North Carolina 27834 |
| Fox Chase Cancer Center CCOP Research Base | Philadelphia, Pennsylvania 19140 |
| Fallon Clinic at Worcester Medical Center | Worcester, Massachusetts 01608 |
| AtlantiCare Regional Medical Center | Pomona, New Jersey 08240 |
| Central Pennsylvania Hematology and Medical Oncology Associates, PC | Lemoyne, Pennsylvania 17043 |
| University of Virginia Cancer Center at UV Health System | Charlottesville, Virginia 22908 |
| Sletten Regional Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
| PinnacleHealth Regional Cancer Center at Polyclinic Hospital | Harrisburg, Pennsylvania 17105 |
| South Carolina Oncology Associates, PA | Columbia, South Carolina 29210 |
| Hackensack, New Jersey 07601 | |
| Lancaster Cancer Center | Lancaster, Pennsylvania 17604 |
| Jersey Shore Cancer Center at Jersey Shore University Medical Center | Neptune, New Jersey 07754-0397 |
| New Hope Cancer and Research Institute - Pomona | Pomona, California 91767 |
| Cancer Center of Indiana | New Albany, Indiana 47150 |
| Annapolis Oncology Center | Annapolis, Maryland 21401 |
| Mercer Bucks Oncology-Hematology | Trenton, New Jersey 08618 |
| Falling Spring Medical Associates | Chambersburg, Pennsylvania 17201 |
| Hematology-Oncology Associates of Northeastern Pennsylvania | Dunmore, Pennsylvania 18512 |
| Richard G. Laube Cancer Center at ACMH | Kittanning, Pennsylvania 16201 |
| Paoli Hematology-Oncology PC at Paoli Memorial Hospital | Paoli, Pennsylvania 19301 |
| Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia | Philadelphia, Pennsylvania 19106 |
| Coastal Cancer Center - Myrtle Beach | Myrtle Beach, South Carolina 29572 |
| Family Cancer Center, PLLC - Collierville | Collierville, Tennessee 38077 |
| David Lee Outpatient Cancer Center at Charleston Area Medical Center | Charleston, West Virginia 25304-1297 |
| Morgantown Internal Medicine Group, Incorporated | Morgantown, West Virginia 26505 |
