Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Carcinoma, Small Cell Clinical Trial

Official title:

A Phase II Trial of Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305942
• Other study ID #: SCRI LUN 117
• Status: Completed
• Phase: Phase 2
• First received: March 20, 2006
• Last updated: January 24, 2013
• Start date: March 2006
• Est. completion date: November 2009

Study information

• Verified date: January 2013
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This proposed phase II trial will investigate the combination of topotecan/carboplatin in the first-line treatment of patients with extensive-stage SCLC. Topotecan/platinum regimens are emerging as common treatments for patients with extensive-stage disease. This trial will be one of the first clinical trials to evaluate a combination of weekly topotecan and carboplatin in the first-line treatment of extensive-stage SCLC.

Description:

Eligible patients will receive treatment with carboplatin and topotecan.

Topotecan 4mg/m2 IV on days 1, 8.

Carboplatin AUC=5 IV day 1 only .

• Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have confirmed small cell lung cancer with extensive stage disease. This includes patients with stage IIIB and IV disease.

• Patients with small cell histology are eligible. Large neuroendocrine or mixed small cell and non-small cell histology are not eligible.

• Patients must have measurable or evaluable disease.

• ECOG performance status 0 or 1.

• Patients must have adequate bone marrow, liver and kidney function

• The patients may have had no previous chemotherapy.

• Patients must be able to understand the nature of the study and give written informed consent.

Exclusion Criteria:

• Patients with limited stage disease. This includes IA, IB, IIA, IIB, and IIIA.

• Age < 18 years old.

• History of a prior malignancy within three years with the exception of skin cancer (excluding melanoma), cervical carcinoma in situ, in situ breast carcinoma or stage A/B prostate cancer.

• Female patients who are pregnant or are breast feeding

• History of acute myocardial infarction or stroke within 6 months.

• Uncontrolled hypertension, unstable angina, New York Heart Association grade II or greater CHF, serious cardiac arrhythmia requiring medication, or grade II or greater peripheral vascular disease.

• Patients who have received other investigational drugs within 28 days.

• Patients with CNS involvement (brain or meningeal). The single exception to this is the patient previously treated for brain metastases with radiation therapy, or surgical excision who has no evidence of active residual metastases on brain MRI at the time of study entry.

• Patients with large neuroendocrine tumor or mixed small cell and non-small cell histology

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Small Cell
• Small Cell Lung Carcinoma

Intervention

Drug:
• Topotecan
Topotecan 4mg/m2 IV on days 1, 8.
• carboplatin
Carboplatin AUC=5 IV day 1 only .

Locations

Country	Name	City	State
United States	Hematology Oncology Life Center	Alexandria	Louisiana
United States	Northeast Alabama Regional Medical Center	Anniston	Alabama
United States	Graves-Gilbert Clinic	Bowling Green	Kentucky
United States	Associates in Hematology Oncology	Chattanooga	Tennessee
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Family Cancer Center	Collierville	Tennessee
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Grand Rapids Clinical Oncology Program	Grand Rapids	Michigan
United States	Northeast Arkansas Clinic	Jonesboro	Arkansas
United States	Watson Clinic Center for Cancer Care and Research	Lakeland	Florida
United States	Consultants in Blood Disorders and Cancer	Louisville	Kentucky
United States	Montana Cancer Institute Foundation	Missoula	Montana
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Mercy Hospital	Portland	Maine
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Spigel DR, Hainsworth JD, Gandhi JG, Gian VG, Peyton JD, West-Osterfield K, Clark BL, Vazquez ER, Jones SF, Burris HA, Greco FA. A phase II trial of carboplatin and weekly topotecan in the first-line treatment of patients with extensive stage small cell l — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment	Overall response rate is the percent of patients experiencing a complete or partial response by RECIST v. 1 Criteria. Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.; The final response category assigned represented the best response obtained during treatment.	18 months	No
Secondary	Time to Progression (TTP), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease	Time to progression is defined as the interval between the start date of treatment and the date of occurrence of progressive disease.	18 months	No
Secondary	Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death	Overall survival was measured from the date of study entry until the date of death.	18 months	No

External Links

•   Published article in the Journal of Thoracic Oncology