Combination Chemotherapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Fox Chase Cancer Center CCOP Research Base
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00054392

Purpose

RATIONALE: Drugs used in chemotherapy such as gemcitabine, carboplatin, and paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating non-small cell lung cancer.

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.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: gemcitabine hydrochloride Drug: paclitaxel	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tumor response rate [ Designated as safety issue: No ]
Time to disease progression [ Designated as safety issue: No ]
Quality of life as measured by the Functional Assessment of Cancer -Lung (FACT-L) questionnaire at baseline, every 6 weeks during study treatment, and then every 3 months thereafter [ Designated as safety issue: No ]

Estimated Enrollment:	1134
Study Start Date:	September 2001

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054392

Hide Study Locations

Locations

United States, California
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
New Hope Cancer and Research Institute - Pomona
Pomona, California, United States, 91767
United States, Connecticut
Lawrence and Memorial Hospital
New London, Connecticut, United States, 06320
United States, Florida
Gulf Coast Cancer Treatment Center
Panama City, Florida, United States, 32405-4587
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States, 33805
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0383
United States, Georgia
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
United States, Illinois
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
United States, Indiana
Cancer Center of Indiana
New Albany, Indiana, United States, 47150
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Greater Baltimore Medical Center Cancer Center
Baltimore, Maryland, United States, 21204
Annapolis Oncology Center
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01107
Fallon Clinic at Worcester Medical Center
Worcester, Massachusetts, United States, 01608
United States, Michigan
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
United States, Montana
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
United States, New Jersey
Jersey Shore Cancer Center at Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07754
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States, 08240
Mercer Bucks Oncology-Hematology
Trenton, New Jersey, United States, 08618

Howell, New Jersey, United States, 07731
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, North Carolina
Cape Fear Valley Medical Center
Fayetteville, North Carolina, United States, 28302-2000
Leo W. Jenkins Cancer Center at ECU Medical School
Greenville, North Carolina, United States, 27834
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States, 44710-1799
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Parma Community General Hospital
Parma, Ohio, United States, 44129
United States, Pennsylvania
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
Central Pennsylvania Hematology and Medical Oncology Associates, PC
Lemoyne, Pennsylvania, United States, 17043
Drexel University College of Medicine - Center City Hahnemann Campus
Philadelphia, Pennsylvania, United States, 19102
Falling Spring Medical Associates
Chambersburg, Pennsylvania, United States, 17201
Fox Chase Cancer Center CCOP Research Base
Philadelphia, Pennsylvania, United States, 19104-4283
Paoli Hematology-Oncology PC at Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301
Hematology-Oncology Associates of Northeastern Pennsylvania
Dunmore, Pennsylvania, United States, 18512
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Lancaster Cancer Center
Lancaster, Pennsylvania, United States, 17605-0396
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102-1192
Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia
Philadelphia, Pennsylvania, United States, 19106
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
Harrisburg, Pennsylvania, United States, 17110
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, United States, 19464
Richard G. Laube Cancer Center at ACMH
Kittanning, Pennsylvania, United States, 16201
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
St. Joseph Medical Center
Reading, Pennsylvania, United States, 19603
United States, South Carolina
Coastal Cancer Center - Myrtle Beach
Myrtle Beach, South Carolina, United States, 29572
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
United States, Tennessee
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
Knoxville, Tennessee, United States, 37901
Family Cancer Center, PLLC - Collierville
Collierville, Tennessee, United States, 38077
United States, Virginia
University of Virginia Cancer Center at UV Health System
Charlottesville, Virginia, United States, 22908
United States, West Virginia
Morgantown Internal Medicine Group, Incorporated
Morgantown, West Virginia, United States, 26505
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9162
David Lee Outpatient Cancer Center at Charleston Area Medical Center
Charleston, West Virginia, United States, 25304-1297

Sponsors and Collaborators

Fox Chase Cancer Center CCOP Research Base

National Cancer Institute (NCI)

Investigators

Study Chair:

Joseph A. Treat, MD

Fox Chase Cancer Center CCOP Research Base

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000270434, ALPHA-A1-99002L
Study First Received:	February 5, 2003
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00054392 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type

Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Paclitaxel
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung

ClinicalTrials.gov processed this record on November 22, 2009