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Paclitaxel in Treating Patients With Extensive-Stage Small Cell Lung Cancer

This study has been completed.

Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005646
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients who have extensive-stage small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: paclitaxel
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Paclitaxel   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Trial of Weekly Dose-Dense Paclitaxel in Extensive Stage Small Cell Lung Cancer

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

Study Start Date:   April 2000

Detailed Description:

OBJECTIVES: I. Determine the complete and overall response rate to paclitaxel in patients with previously untreated extensive stage small cell lung cancer. II. Determine the overall and progression free survival of these patients in response to this treatment regimen. III. Determine the toxicity of this treatment regimen in this patient population.

OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours weekly for 6 consecutive weeks. Treatment continues every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, then every 3 months for 2 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study over 8-11 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 extensive stage small cell carcinoma of the bronchus Extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy or contralateral hilar adenopathy Measurable disease One lesion that measures at least 20 mm in diameter using conventional techniques or at least 10 mm with spiral CT scan Lesions not considered measurable include: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Cystic lesions Tumor lesions situated in a previously irradiated area Abdominal masses not confirmed and followed by imaging techniques No disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CTC 0-2 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT less than 2 times upper limit of normal Bilirubin less than 1.5 mg/dL Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent hormonal therapy except steroids for renal failure or hormones administered for nondisease related conditions Radiotherapy: At least two weeks since prior radiotherapy No concurrent palliative radiotherapy Surgery: Not specified

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005646

Locations
United States, Missouri
Ellis Fischel Cancer Center - Columbia    
      Columbia, Missouri, United States, 65203
United States, New York
State University of New York - Upstate Medical University    
      Syracuse, New York, United States, 13210
United States, North Carolina
Duke Comprehensive Cancer Center    
      Durham, North Carolina, United States, 27710
Lineberger Comprehensive Cancer Center, UNC    
      Chapel Hill, North Carolina, United States, 27599-7295
United States, South Carolina
Medical University of South Carolina    
      Charleston, South Carolina, United States, 29425-0721

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

Investigators
Study Chair:     Mark A. Socinski, MD     UNC Lineberger Comprehensive Cancer Center    
  More Information


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

Publications of Results:
Graziano SL, Herndon JE 2nd, Socinski MA, Wang X, Watson D, Vokes E, Green MR; Cancer and Leukemia Group B. Phase II trial of weekly dose-dense paclitaxel in extensive-stage small cell lung cancer: cancer and leukemia group B study 39901. J Thorac Oncol. 2008 Feb;3(2):158-62.
 
Graziano SL, Socinski MA, Herndon JE, et al.: Dose-dense weekly paclitaxel (P) in extensive stage small cell lung cancer (ES-SCLC): Cancer and Leukemia Group B (CALGB) 39901. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2598, 646, 2003.
 

Other Publications:

Study ID Numbers:   CDR0000067826, CLB-39901
First Received:   May 2, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005646
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
extensive stage small cell lung cancer  

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases
Paclitaxel
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on December 03, 2008




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