Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054392
Recruitment Status : Withdrawn (Not opened at Fox Chase Cancer Center)
First Posted : February 6, 2003
Last Update Posted : July 11, 2013
National Cancer Institute (NCI)
Information provided by:
Fox Chase Cancer Center

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: carboplatin Drug: gemcitabine hydrochloride Drug: paclitaxel Phase 3

Detailed Description:


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Primary Purpose: Treatment
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 Start Date : September 2001
Actual Primary Completion Date : September 2001
Actual Study Completion Date : September 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Primary Outcome Measures :
  1. Survival

Secondary Outcome Measures :
  1. Tumor response rate
  2. Time to disease progression
  3. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL
  • AST less than 5 times upper limit of normal


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 40 mL/min


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No hypersensitivity to agents that contain Cremophor EL (polyoxyethylated castor oil)


Biologic therapy

  • Not specified


  • No prior chemotherapy for advanced NSCLC

Endocrine therapy

  • Not specified


  • 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)


  • See Disease Characteristics


  • No concurrent aminoglycoside antibiotics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00054392

Show Show 57 study locations
Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Joseph A. Treat, MD Fox Chase Cancer Center

Publications of Results:
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.

Layout table for additonal information Identifier: NCT00054392    
Other Study ID Numbers: ALPHA-A1-99002L
CDR0000270434 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013
Keywords provided by Fox Chase Cancer Center:
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:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs