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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00005646
First received: May 2, 2000
Last updated: September 27, 2013
Last verified: September 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Weekly Dose-Dense Paclitaxel in Extensive Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 1 year post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 12 months post treatment ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 12 months post treatment ] [ Designated as safety issue: No ]
  • Overall response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 1 year post treatment ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: April 2000
Study Completion Date: February 2008
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel
Patients receive paclitaxel for up to 4 cycles. One cycle = weekly drug for 6 weeks and 2 weeks rest
Drug: paclitaxel
150 mg/sq m IV over 3 hours weekly for 6 weeks per cycle

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
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, see Learn About Clinical Studies.

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
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Mark A. Socinski, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00005646     History of Changes
Other Study ID Numbers: CDR0000067826, U10CA031946, CLB-39901
Study First Received: May 2, 2000
Last Updated: September 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
extensive stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014