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

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

Sponsoren

Hauptsponsor: Fox Chase Cancer Center

Mitarbeiter: National Cancer Institute (NCI)

Quelle Fox Chase Cancer Center
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Withdrawn
Anfangsdatum September 2001
Fertigstellungstermin September 2001
Primäres Abschlussdatum September 2001
Phase Phase 3
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Survival
Sekundäres Ergebnis
Messen Zeitfenster
Tumor response rate
Time to disease progression
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
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: carboplatin

Interventionsart: Drug

Interventionsname: gemcitabine hydrochloride

Interventionsart: Drug

Interventionsname: paclitaxel

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Joseph A. Treat, MD Study Chair Fox Chase Cancer Center
Ort
Einrichtung:
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California, 92354, United States
New Hope Cancer and Research Institute - Pomona | Pomona, California, 91767, United States
Lawrence and Memorial Hospital | New London, Connecticut, 06320, United States
University of Florida Shands Cancer Center | Gainesville, Florida, 32610-0383, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center | Lakeland, Florida, 33805, United States
Gulf Coast Cancer Treatment Center | Panama City, Florida, 32405-4587, United States
Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur, Georgia, 30033, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital | Harvey, Illinois, 60426, United States
Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois, 61801, United States
Cancer Center of Indiana | New Albany, Indiana, 47150, United States
CCOP - Northern Indiana CR Consortium | South Bend, Indiana, 46601, United States
Annapolis Oncology Center | Annapolis, Maryland, 21401, United States
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland, 21201, United States
Greater Baltimore Medical Center Cancer Center | Baltimore, Maryland, 21204, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield, Massachusetts, 01107, United States
Fallon Clinic at Worcester Medical Center | Worcester, Massachusetts, 01608, United States
West Michigan Cancer Center | Kalamazoo, Michigan, 49007-3731, United States
Sletten Regional Cancer Institute at Benefis Healthcare | Great Falls, Montana, 59405, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington, New Jersey, 08822, United States
| Howell, New Jersey, 07731, United States
Jersey Shore Cancer Center at Jersey Shore University Medical Center | Neptune, New Jersey, 07754, United States
AtlantiCare Regional Medical Center | Pomona, New Jersey, 08240, United States
Mercer Bucks Oncology-Hematology | Trenton, New Jersey, 08618, United States
Roswell Park Cancer Institute | Buffalo, New York, 14263-0001, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina, 27599-7295, United States
Cape Fear Valley Medical Center | Fayetteville, North Carolina, 28302-2000, United States
Leo W. Jenkins Cancer Center at ECU Medical School | Greenville, North Carolina, 27834, United States
Aultman Hospital Cancer Center at Aultman Health Foundation | Canton, Ohio, 44710-1799, United States
Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio, 44111, United States
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio, 44195, United States
Parma Community General Hospital | Parma, Ohio, 44129, United States
Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania, 19001, United States
Falling Spring Medical Associates | Chambersburg, Pennsylvania, 17201, United States
Hematology-Oncology Associates of Northeastern Pennsylvania | Dunmore, Pennsylvania, 18512, United States
PinnacleHealth Regional Cancer Center at Polyclinic Hospital | Harrisburg, Pennsylvania, 17110, United States
Richard G. Laube Cancer Center at ACMH | Kittanning, Pennsylvania, 16201, United States
Lancaster Cancer Center | Lancaster, Pennsylvania, 17605-0396, United States
Central Pennsylvania Hematology and Medical Oncology Associates, PC | Lemoyne, Pennsylvania, 17043, United States
Paoli Hematology-Oncology PC at Paoli Memorial Hospital | Paoli, Pennsylvania, 19301, United States
Hahnemann University Hospital | Philadelphia, Pennsylvania, 19102-1192, United States
Drexel University College of Medicine - Center City Hahnemann Campus | Philadelphia, Pennsylvania, 19102, United States
Fox Chase Cancer Center CCOP Research Base | Philadelphia, Pennsylvania, 19104-4283, United States
Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia | Philadelphia, Pennsylvania, 19106, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania, 19107-5541, United States
Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania, 15212-4772, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania, 15232, United States
Pottstown Memorial Regional Cancer Center | Pottstown, Pennsylvania, 19464, United States
St. Joseph Medical Center | Reading, Pennsylvania, 19603, United States
Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania, 19096, United States
South Carolina Oncology Associates, PA | Columbia, South Carolina, 29210, United States
Coastal Cancer Center - Myrtle Beach | Myrtle Beach, South Carolina, 29572, United States
Family Cancer Center, PLLC - Collierville | Collierville, Tennessee, 38077, United States
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee | Knoxville, Tennessee, 37901, United States
University of Virginia Cancer Center at UV Health System | Charlottesville, Virginia, 22908, United States
David Lee Outpatient Cancer Center at Charleston Area Medical Center | Charleston, West Virginia, 25304-1297, United States
Morgantown Internal Medicine Group, Incorporated | Morgantown, West Virginia, 26505, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown, West Virginia, 26506-9162, United States
Standort Länder

United States

Überprüfungsdatum

July 2013

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Randomized

Hauptzweck: Treatment

Quelle: ClinicalTrials.gov