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

• ClinicalTrials.gov Identifier: NCT00305942
• Recruitment Status: Completed
• First Posted: March 22, 2006
• Results First Posted: January 24, 2013
• Last Update Posted: January 31, 2013
• Sponsor: SCRI Development Innovations, LLC
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): SCRI Development Innovations, LLC

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Carcinoma, Small Cell	Drug: Topotecan; Drug: carboplatin	Phase 2

Detailed 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.)

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 61 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Trial of Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer
• Study Start Date: March 2006
• Actual Primary Completion Date: April 2009
• Actual Study Completion Date: November 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; 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.)	Drug: Topotecan; Topotecan 4mg/m2 IV on days 1, 8.; Other Name: Hycamtin; Drug: carboplatin; Carboplatin AUC=5 IV day 1 only .; Other Name: 41575-94-4

Outcome Measures

Primary Outcome Measures :

1. Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment [ Time Frame: 18 months ]

   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.

Secondary Outcome Measures :

1. 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 Frame: 18 months ]
   Time to progression is defined as the interval between the start date of treatment and the date of occurrence of progressive disease.
2. Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [ Time Frame: 18 months ]
   Overall survival was measured from the date of study entry until the date of death.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Alabama

Northeast Alabama Regional Medical Center

Anniston, Alabama, United States, 36207

United States, Arkansas

Northeast Arkansas Clinic

Jonesboro, Arkansas, United States, 72401

United States, Florida

Florida Cancer Specialists

Fort Myers, Florida, United States, 33901

Watson Clinic Center for Cancer Care and Research

Lakeland, Florida, United States, 33805

United States, Georgia

Northeast Georgia Medical Center

Gainesville, Georgia, United States, 30501

United States, Kentucky

Graves-Gilbert Clinic

Bowling Green, Kentucky, United States, 42101

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, United States, 40207

United States, Louisiana

Hematology Oncology Life Center

Alexandria, Louisiana, United States, 71301

United States, Maine

Mercy Hospital

Portland, Maine, United States, 04101

United States, Michigan

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, United States, 49503

United States, Montana

Montana Cancer Institute Foundation

Missoula, Montana, United States, 59802

United States, Ohio

Oncology Hematology Care

Cincinnati, Ohio, United States, 45242

United States, South Carolina

Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States, 29303

United States, Tennessee

Associates in Hematology Oncology

Chattanooga, Tennessee, United States, 37404

Family Cancer Center

Collierville, Tennessee, United States, 38017

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37023

Sponsors and Collaborators

SCRI Development Innovations, LLC

GlaxoSmithKline

Investigators

• Principal Investigator: David R. Spigel, MD; SCRI Development Innovations, LLC

More Information

Additional Information:

Published article in the Journal of Thoracic Oncology 

Publications of Results:

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 lung cancer. J Thorac Oncol. 2010 Jun;5(6):862-6.

• Responsible Party: SCRI Development Innovations, LLC
• ClinicalTrials.gov Identifier: NCT00305942
• Other Study ID Numbers: SCRI LUN 117
• First Posted: March 22, 2006
• Results First Posted: January 24, 2013
• Last Update Posted: January 31, 2013
• Last Verified: January 2013

Keywords provided by SCRI Development Innovations, LLC:

Lung Cancer; Carcinoma, Small Cell

Additional relevant MeSH terms:

Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Small Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carboplatin; Topotecan; Antineoplastic Agents; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action