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

July 10, 2013 updated by: Fox Chase Cancer Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival

Secondary Outcome Measures

Outcome Measure
Time to disease progression
Tumor response rate
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fox Chase Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Joseph A. Treat, MD, Fox Chase Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

September 1, 2001

Study Completion (Actual)

September 1, 2001

Study Registration Dates

First Submitted

February 5, 2003

First Submitted That Met QC Criteria

February 5, 2003

First Posted (Estimate)

February 6, 2003

Study Record Updates

Last Update Posted (Estimate)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALPHA-A1-99002L
  • CDR0000270434 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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