Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer
A Phase II Trial of Topotecan and Carboplatin in the First-Line Treatment of Patients With Extensive Stage Small Cell Lung Cancer
1 other identifier
interventional
61
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2006
Typical duration for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
March 20, 2006
CompletedFirst Posted
Study publicly available on registry
March 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
January 24, 2013
CompletedJanuary 31, 2013
January 1, 2013
3.1 years
March 20, 2006
December 18, 2012
January 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
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
18 months
Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
18 months
Study Arms (1)
1
EXPERIMENTALTopotecan 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.)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- GlaxoSmithKlinecollaborator
Study Sites (16)
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207, United States
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401, United States
Florida Cancer Specialists
Fort Myers, Florida, 33901, United States
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, 33805, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207, United States
Hematology Oncology Life Center
Alexandria, Louisiana, 71301, United States
Mercy Hospital
Portland, Maine, 04101, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
Montana Cancer Institute Foundation
Missoula, Montana, 59802, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Associates in Hematology Oncology
Chattanooga, Tennessee, 37404, United States
Family Cancer Center
Collierville, Tennessee, 38017, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023, United States
Related 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 lung cancer. J Thorac Oncol. 2010 Jun;5(6):862-6. doi: 10.1097/jto.0b013e3181d86a4f.
PMID: 20521352RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- John Hainsworth, MD
- Organization
- Sarah Cannon Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
David R. Spigel, MD
SCRI Development Innovations, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2006
First Posted
March 22, 2006
Study Start
March 1, 2006
Primary Completion
April 1, 2009
Study Completion
November 1, 2009
Last Updated
January 31, 2013
Results First Posted
January 24, 2013
Record last verified: 2013-01