Back to resultsA Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy
Primary Purpose
Small Cell Lung Cancer, Carcinoma, Small Cell, SCLC
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
pemetrexed
cisplatin
radiation
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Measurable disease with diagnosis of Small Cell Lung Cancer.
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group performance status schedule.
- Patients must be at least 18 years of age and have at least a 12-week life expectancy.
- No prior chemotherapy and/or prior thoracic radiotherapy.
- Adequate pulmonary function and organ function.
Exclusion Criteria:
- Patients with myocardial infarction within the preceding six months.
- Diagnosis of a serious concomitant systemic disorder.
- Prior radiotherapy to the lower neck or abdominal region.
- Significant weight loss.
- Concurrent administration of any other antitumor therapy.
Sites / Locations
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Phase 1: Maximum Tolerated Dose
Phase 2: Overall Response Rate
Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.
Secondary Outcome Measures
Phase 1: Best Overall Response
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Phase 2: Complete Response Rate
Complete Response Rate was defined as the proportion of participants having a Complete Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions.
Phase 2: Time to Progressive Disease
Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Phase 2: Duration of Response
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Phase 2: Overall Survival
Overall survival was the duration from enrollment to death. For patients who were alive, overall survival was censored at the last contact.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00447421
Brief Title
A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy
Official Title
Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Terminated
Why Stopped
Interim results of another trial showed inferior activity of treatment
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the recommended dose of pemetrexed, cisplatin and radiotherapy in the treatment of patients with Small Cell Lung Cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer, Carcinoma, Small Cell, SCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Other Intervention Name(s)
LY231514, Alimta
Intervention Description
Phase 1: 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)
Phase 2: 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Intervention Type
Radiation
Intervention Name(s)
radiation
Intervention Description
Phase 1 and Phase 2: 50-62 Gy, 25-31 days, cycles 2-4
Primary Outcome Measure Information:
Title
Phase 1: Maximum Tolerated Dose
Time Frame
every cycle
Title
Phase 2: Overall Response Rate
Description
Overall Response Rate (ORR) was defined as the proportion of participants having either a Complete or Partial response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions.
Time Frame
baseline to measured progressive disease
Secondary Outcome Measure Information:
Title
Phase 1: Best Overall Response
Description
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Time Frame
baseline to measured response
Title
Phase 2: Complete Response Rate
Description
Complete Response Rate was defined as the proportion of participants having a Complete Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions.
Time Frame
baseline to measured response time
Title
Phase 2: Time to Progressive Disease
Description
Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
Time Frame
baseline to measured progressive disease
Title
Phase 2: Duration of Response
Description
The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Time Frame
time of response to progressive disease
Title
Phase 2: Overall Survival
Description
Overall survival was the duration from enrollment to death. For patients who were alive, overall survival was censored at the last contact.
Time Frame
baseline to date of death from any cause
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Measurable disease with diagnosis of Small Cell Lung Cancer.
Performance status of 0 to 1 on the Eastern Cooperative Oncology Group performance status schedule.
Patients must be at least 18 years of age and have at least a 12-week life expectancy.
No prior chemotherapy and/or prior thoracic radiotherapy.
Adequate pulmonary function and organ function.
Exclusion Criteria:
Patients with myocardial infarction within the preceding six months.
Diagnosis of a serious concomitant systemic disorder.
Prior radiotherapy to the lower neck or abdominal region.
Significant weight loss.
Concurrent administration of any other antitumor therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Den Bosch
ZIP/Postal Code
5211 NL
Country
Netherlands
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy
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