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

Primary Purpose

Lung Cancer

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
carboplatin
gemcitabine hydrochloride
paclitaxel
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center
  • New Hope Cancer and Research Institute - Pomona
  • Lawrence and Memorial Hospital
  • University of Florida Shands Cancer Center
  • Lakeland Regional Cancer Center at Lakeland Regional Medical Center
  • Gulf Coast Cancer Treatment Center
  • Veterans Affairs Medical Center - Atlanta (Decatur)
  • Ingalls Cancer Care Center at Ingalls Memorial Hospital
  • Carle Cancer Center at Carle Foundation Hospital
  • Cancer Center of Indiana
  • CCOP - Northern Indiana CR Consortium
  • Annapolis Oncology Center
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Greater Baltimore Medical Center Cancer Center
  • Baystate Regional Cancer Program at D'Amour Center for Cancer Care
  • Fallon Clinic at Worcester Medical Center
  • West Michigan Cancer Center
  • Sletten Regional Cancer Institute at Benefis Healthcare
  • Hunterdon Regional Cancer Center at Hunterdon Medical Center
  • Jersey Shore Cancer Center at Jersey Shore University Medical Center
  • AtlantiCare Regional Medical Center
  • Mercer Bucks Oncology-Hematology
  • Roswell Park Cancer Institute
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Cape Fear Valley Medical Center
  • Leo W. Jenkins Cancer Center at ECU Medical School
  • Aultman Hospital Cancer Center at Aultman Health Foundation
  • Cleveland Clinic Cancer Center at Fairview Hospital
  • Cleveland Clinic Taussig Cancer Center
  • Parma Community General Hospital
  • Rosenfeld Cancer Center at Abington Memorial Hospital
  • Falling Spring Medical Associates
  • Hematology-Oncology Associates of Northeastern Pennsylvania
  • PinnacleHealth Regional Cancer Center at Polyclinic Hospital
  • Richard G. Laube Cancer Center at ACMH
  • Lancaster Cancer Center
  • Central Pennsylvania Hematology and Medical Oncology Associates, PC
  • Paoli Hematology-Oncology PC at Paoli Memorial Hospital
  • Hahnemann University Hospital
  • Drexel University College of Medicine - Center City Hahnemann Campus
  • Fox Chase Cancer Center CCOP Research Base
  • Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Allegheny Cancer Center at Allegheny General Hospital
  • Hillman Cancer Center at University of Pittsburgh Cancer Institute
  • Pottstown Memorial Regional Cancer Center
  • St. Joseph Medical Center
  • Lankenau Cancer Center at Lankenau Hospital
  • South Carolina Oncology Associates, PA
  • Coastal Cancer Center - Myrtle Beach
  • Family Cancer Center, PLLC - Collierville
  • Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
  • University of Virginia Cancer Center at UV Health System
  • David Lee Outpatient Cancer Center at Charleston Area Medical Center
  • Morgantown Internal Medicine Group, Incorporated
  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

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

Full Information

First Posted
February 5, 2003
Last Updated
July 10, 2013
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00054392
Brief Title
Combination Chemotherapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Not opened at Fox Chase Cancer Center
Study Start Date
September 2001 (undefined)
Primary Completion Date
September 2001 (Actual)
Study Completion Date
September 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Primary Outcome Measure Information:
Title
Survival
Secondary Outcome Measure Information:
Title
Tumor response rate
Title
Time to disease progression
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph A. Treat, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Loma Linda University Cancer Institute at Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
New Hope Cancer and Research Institute - Pomona
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Lawrence and Memorial Hospital
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0383
Country
United States
Facility Name
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Gulf Coast Cancer Treatment Center
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405-4587
Country
United States
Facility Name
Veterans Affairs Medical Center - Atlanta (Decatur)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Ingalls Cancer Care Center at Ingalls Memorial Hospital
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
Facility Name
Carle Cancer Center at Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Cancer Center of Indiana
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Annapolis Oncology Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Greater Baltimore Medical Center Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Fallon Clinic at Worcester Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01608
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Sletten Regional Cancer Institute at Benefis Healthcare
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Hunterdon Regional Cancer Center at Hunterdon Medical Center
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
City
Howell
State/Province
New Jersey
ZIP/Postal Code
07731
Country
United States
Facility Name
Jersey Shore Cancer Center at Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
Facility Name
AtlantiCare Regional Medical Center
City
Pomona
State/Province
New Jersey
ZIP/Postal Code
08240
Country
United States
Facility Name
Mercer Bucks Oncology-Hematology
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08618
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Cape Fear Valley Medical Center
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28302-2000
Country
United States
Facility Name
Leo W. Jenkins Cancer Center at ECU Medical School
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Aultman Hospital Cancer Center at Aultman Health Foundation
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710-1799
Country
United States
Facility Name
Cleveland Clinic Cancer Center at Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Parma Community General Hospital
City
Parma
State/Province
Ohio
ZIP/Postal Code
44129
Country
United States
Facility Name
Rosenfeld Cancer Center at Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Falling Spring Medical Associates
City
Chambersburg
State/Province
Pennsylvania
ZIP/Postal Code
17201
Country
United States
Facility Name
Hematology-Oncology Associates of Northeastern Pennsylvania
City
Dunmore
State/Province
Pennsylvania
ZIP/Postal Code
18512
Country
United States
Facility Name
PinnacleHealth Regional Cancer Center at Polyclinic Hospital
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Richard G. Laube Cancer Center at ACMH
City
Kittanning
State/Province
Pennsylvania
ZIP/Postal Code
16201
Country
United States
Facility Name
Lancaster Cancer Center
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17605-0396
Country
United States
Facility Name
Central Pennsylvania Hematology and Medical Oncology Associates, PC
City
Lemoyne
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Paoli Hematology-Oncology PC at Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301
Country
United States
Facility Name
Hahnemann University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102-1192
Country
United States
Facility Name
Drexel University College of Medicine - Center City Hahnemann Campus
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Fox Chase Cancer Center CCOP Research Base
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States
Facility Name
Allegheny Cancer Center at Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212-4772
Country
United States
Facility Name
Hillman Cancer Center at University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Pottstown Memorial Regional Cancer Center
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
Facility Name
St. Joseph Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19603
Country
United States
Facility Name
Lankenau Cancer Center at Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
South Carolina Oncology Associates, PA
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29210
Country
United States
Facility Name
Coastal Cancer Center - Myrtle Beach
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Family Cancer Center, PLLC - Collierville
City
Collierville
State/Province
Tennessee
ZIP/Postal Code
38077
Country
United States
Facility Name
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
Country
United States
Facility Name
University of Virginia Cancer Center at UV Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
David Lee Outpatient Cancer Center at Charleston Area Medical Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304-1297
Country
United States
Facility Name
Morgantown Internal Medicine Group, Incorporated
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506-9162
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20035187
Citation
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.
Results Reference
result
PubMed Identifier
20593535
Citation
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.
Results Reference
result
PubMed Identifier
19833819
Citation
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.
Results Reference
result
PubMed Identifier
20347506
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

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

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