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Phase II Trial of Weekly Dose-Dense Paclitaxel in Extensive Stage Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase II Trial of Weekly Dose-Dense Paclitaxel in Extensive Stage Small Cell Lung Cancer

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.

Inclusion 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Time Frame:

1 year post treatment

Safety Issue:


Principal Investigator

Mark A. Socinski, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 2000

Completion Date:

February 2008

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



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