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Gemcitabine Plus Docetaxel or Irinotecan in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004139
  Purpose

RATIONALE: Drugs used in chemotherapy 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.

PURPOSE: Phase II trial to compare the effectiveness of gemcitabine plus either docetaxel or irinotecan in treating patients who have stage IIIB or stage IV non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: docetaxel
Drug: gemcitabine hydrochloride
Drug: irinotecan hydrochloride
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

ChemIDplus related topics:   Docetaxel    Irinotecan    Irinotecan hydrochloride    Gemcitabine hydrochloride    Gemcitabine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   Phase II Randomized Trial of Gemcitabine/Docetaxel and Gemcitabine/Irinotecan in Stage IIIB/IV Non-Small Cell Lung Cancer

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

Study Start Date:   September 1999

Detailed Description:

OBJECTIVES: I. Compare the complete and overall response rate to gemcitabine and docetaxel versus gemcitabine and irinotecan in chemotherapy naive patients with stage IIIB or IV non-small cell lung cancer. II. Compare the overall and failure free survival, duration of response, and toxicity associated with these combination regimens in this patient population.

OUTLINE: This is a randomized study. Patients are stratified according to disease stage (stage IIIB vs stage IV without CNS involvement vs stage IV with CNS involvement vs recurrent/progressive disease post surgery and/or radiotherapy). Patients are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes immediately followed by irinotecan IV over 90 minutes on days 1 and 8. Arm II: Patients receive gemcitabine IV over 30 minutes immediately followed by docetaxel IV over 60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving partial or complete response or stable disease receive treatment for least 6 courses and for 2 additional courses beyond the maximum response, and then at the investigator's discretion. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter until disease progression or death.

PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this study within 12 months.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIB, IV, or recurrent non-small cell lung cancer (NSCLC) including: Squamous cell carcinoma Adenocarcinoma (including bronchoalveolar cell) Large cell anaplastic carcinoma (including giant and clear cell carcinomas) Stage IIIB eligible for other CALGB protocols consisting of combined chemotherapy and chest radiotherapy not permitted Malignant pleural effusion allowed CNS metastases allowed following completion of cranial radiotherapy Unidimesionally or bidimensionally measurable disease Solid tumor mass or hilar lesion surrounded by aerated lung Pleural based mass Mediastinal or hilar adenopathy clearly measurable No bone only disease No pleural or pericardial effusions No irradiated lesions unless progression is documented following radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase less than 2.5 times ULN if SGOT is greater than 1.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix or breast Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior chemotherapy for NSCLC Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy At least 2 weeks since prior whole brain radiotherapy or stereotactic radiotherapy for CNS disease Surgery: At least 2 weeks since prior surgery for CNS disease

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004139

Locations
United States, District of Columbia
Vincent T. Lombardi Cancer Research Center, Georgetown University    
      Washington, District of Columbia, United States, 20007
Walter Reed Army Medical Center    
      Washington, District of Columbia, United States, 20307-5000
United States, Missouri
Barnes-Jewish Hospital    
      Saint Louis, Missouri, United States, 63110
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation    
      Las Vegas, Nevada, United States, 89106
United States, North Carolina
Duke Comprehensive Cancer Center    
      Durham, North Carolina, United States, 27710
United States, South Carolina
CCOP - Greenville    
      Greenville, South Carolina, United States, 29615
Medical University of South Carolina    
      Charleston, South Carolina, United States, 29425-0721
United States, Tennessee
University of Tennessee, Memphis Cancer Center    
      Memphis, Tennessee, United States, 38163

Sponsors and Collaborators
Cancer and Leukemia Group B
National Cancer Institute (NCI)

Investigators
Study Chair:     Caio Max S. Rocha Lima, MD     Medical University of South Carolina    
  More Information


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

Publications of Results:
Rocha Lima CM, Rizvi NA, Zhang C, Herndon JE 2nd, Crawford J, Govindan R, King GW, Green MR; Cancer Leukemia Group B. Randomized phase II trial of gemcitabine plus irinotecan or docetaxel in stage IIIB or stage IV NSCLC. Ann Oncol. 2004 Mar;15(3):410-8. Review.
 
Rocha Lima CM, Rizvi NA, Zhang K, et al.: CALGB 39809: Randomized phase II trial of gemcitabine/irinotecan and gemcitabine/docetaxel in stage IIIB (malignant pleural effusion) or stage IV NSCLC. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1344, 2002.
 

Study ID Numbers:   CDR0000067369, CLB-39809
First Received:   December 10, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004139
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer  
squamous cell lung cancer  
large cell lung cancer  
stage IIIB non-small cell lung cancer  
stage IV non-small cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma, Bronchiolo-Alveolar
Irinotecan
Camptothecin
Recurrence
Carcinoma
Docetaxel
Adenocarcinoma of lung
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 07, 2008




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