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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

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 InstituteBuffalo, New York  14263
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Baystate Regional Cancer Program at D'Amour Center for Cancer CareSpringfield, Massachusetts  01199
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Drexel University College of Medicine - Center City Hahnemann CampusPhiladelphia, Pennsylvania  19102
Gulf Coast Cancer Treatment CenterPanama City, Florida  32405-4587
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
Aultman Hospital Cancer Center at Aultman Health FoundationCanton, Ohio  44710-1799
Hunterdon Regional Cancer Center at Hunterdon Medical CenterFlemington, New Jersey  08822
Parma Community General HospitalParma, Ohio  44129
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Cape Fear Valley Medical CenterFayetteville, North Carolina  28302-2000
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Lakeland Regional Cancer Center at Lakeland Regional Medical CenterLakeland, Florida  33805
Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois  60426
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Baptist Regional Cancer Center at Baptist Hospital of East TennesseeKnoxville, Tennessee  37901
Lawrence and Memorial HospitalNew London, Connecticut  06320
Pottstown Memorial Regional Cancer CenterPottstown, Pennsylvania  19464
Allegheny Cancer Center at Allegheny General HospitalPittsburgh, Pennsylvania  15212
St. Joseph Medical CenterReading, Pennsylvania  19604
Greater Baltimore Medical Center Cancer CenterBaltimore, Maryland  21204
Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenville, North Carolina  27834
Fox Chase Cancer Center CCOP Research BasePhiladelphia, Pennsylvania  19140
Fallon Clinic at Worcester Medical CenterWorcester, Massachusetts  01608
AtlantiCare Regional Medical CenterPomona, New Jersey  08240
Central Pennsylvania Hematology and Medical Oncology Associates, PCLemoyne, Pennsylvania  17043
University of Virginia Cancer Center at UV Health SystemCharlottesville, Virginia  22908
Sletten Regional Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
PinnacleHealth Regional Cancer Center at Polyclinic HospitalHarrisburg, Pennsylvania  17105
South Carolina Oncology Associates, PAColumbia, South Carolina  29210
Hackensack, New Jersey  07601
Lancaster Cancer CenterLancaster, Pennsylvania  17604
Jersey Shore Cancer Center at Jersey Shore University Medical CenterNeptune, New Jersey  07754-0397
New Hope Cancer and Research Institute - PomonaPomona, California  91767
Cancer Center of IndianaNew Albany, Indiana  47150
Annapolis Oncology CenterAnnapolis, Maryland  21401
Mercer Bucks Oncology-HematologyTrenton, New Jersey  08618
Falling Spring Medical AssociatesChambersburg, Pennsylvania  17201
Hematology-Oncology Associates of Northeastern PennsylvaniaDunmore, Pennsylvania  18512
Richard G. Laube Cancer Center at ACMHKittanning, Pennsylvania  16201
Paoli Hematology-Oncology PC at Paoli Memorial HospitalPaoli, Pennsylvania  19301
Pennsylvania Oncology Hematology Associates, Incorporated - PhiladelphiaPhiladelphia, Pennsylvania  19106
Coastal Cancer Center - Myrtle BeachMyrtle Beach, South Carolina  29572
Family Cancer Center, PLLC - ColliervilleCollierville, Tennessee  38077
David Lee Outpatient Cancer Center at Charleston Area Medical CenterCharleston, West Virginia  25304-1297
Morgantown Internal Medicine Group, IncorporatedMorgantown, West Virginia  26505