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Combination Chemotherapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: February 5, 2003   Last Updated: February 17, 2009   History of Changes
Sponsors and Collaborators: Fox Chase Cancer Center CCOP Research Base
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00054392
  Purpose

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 Intervention Phase
Lung Cancer
 Drug: carboplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Paclitaxel Carboplatin Gemcitabine Gemcitabine hydrochloride
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response rate [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

Estimated Enrollment: 1134
Study Start Date: September 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054392

  Show 57 Study Locations
Sponsors and Collaborators
Fox Chase Cancer Center CCOP Research Base
National Cancer Institute (NCI)
Investigators
Study Chair: Joseph A. Treat, MD Fox Chase Cancer Center CCOP Research Base
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
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.

Study ID Numbers: CDR0000270434, ALPHA-A1-99002L
Study First Received: February 5, 2003
Last Updated: February 17, 2009
ClinicalTrials.gov Identifier: NCT00054392     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Antimetabolites
Thoracic Neoplasms
Immunologic Factors
Adenocarcinoma, Bronchiolo-Alveolar
Antimitotic Agents
Carboplatin
Immunosuppressive Agents
Antiviral Agents
Recurrence
Carcinoma
Radiation-Sensitizing Agents
Respiratory Tract Diseases
 Paclitaxel
Lung Neoplasms
Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Adenocarcinoma of Lung
Adenocarcinoma
Gemcitabine
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
 Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Paclitaxel
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung

ClinicalTrials.gov processed this record on July 02, 2009



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