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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005646
• Other study ID #: CALGB-39901
• Secondary ID: U10CA031946CLB-3
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2000
• Last updated: July 12, 2016
• Start date: April 2000
• Est. completion date: February 2008

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2008
• Est. primary completion date: January 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• paclitaxel
150 mg/sq m IV over 3 hours weekly for 6 weeks per cycle

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	State University of New York - Upstate Medical University	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Blackstock AW, Herndon JE 2nd, Paskett ED, Miller AA, Lathan C, Niell HB, Socinski MA, Vokes EE, Green MR; Cancer and Leukemia Group B. Similar outcomes between African American and non-African American patients with extensive-stage small-cell lung carcinoma: report from the Cancer and Leukemia Group B. J Clin Oncol. 2006 Jan 20;24(3):407-12. Epub 2005 Dec 19. — View Citation

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. — View Citation

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,

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		1 year post treatment	No
Secondary	Progression-free survival		12 months post treatment	No
Secondary	Overall survival		12 months post treatment	No
Secondary	Overall response		12 months	No
Secondary	Toxicity		1 year post treatment	Yes