Back to resultsPemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer
Primary Purpose
Small Cell Lung Cancer
Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
pemetrexed
cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologic or cytologic diagnosis of Small Cell Lung Cancer (SCLC).
- Functional stage from 0 to 2 of the ECOG functional scale
- No previous systemic chemotherapy, immunotherapy or biologic therapy for SCLC.
- Previous bone marrow radiotherapy less than 25% is allowed.
- There must be at least one measurable lesion that complies with the solid tumor response evaluation criteria.
- Appropriate organic function.
- Life expectancy estimated at 12 weeks minimum.
- Females must be surgically sterile, postmenopausal or follow approved medical contraceptive methods during the treatment period and 6 months afterwards. Males must be surgically sterile or use a contraceptive method during the treatment period and during 6 months after treatment.
- The patient must be compliant and located close to the trial area for appropriate follow-up.
- The patient or his/her legal representative must sign an informed consent document.
- Patients must be at least 18 years of age.
Exclusion Criteria:
- Having received treatment for the last 30 days with a drug that has not obtained regulatory approval.
- Having participated in a previous pemetrexed trial.
- Mixed histologic diagnosis of SCLC and NSCLC.
- Concurrent illness.
- Having an active infection.
- Severe cardiac disease.
- Having received recently or concurrently a vaccine against yellow fever.
- Having suffered a previous malignant process other than SCLC.
- Central nervous system (CNS) metastases require concurrent corticoid therapy. Treated and stable CNS metastases are allowed.
- Clinically relevant fluid accumulation in the third space.
- Significant weight loss (greater than or equal to 10%) within 6 weeks prior to trial inclusion.
- Concurrent administration of any other anti-tumor treatment.
- Severe renal failure.
- Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDS) agents.
- Inability or unwillingness to take folic acid and vitamin B12 supplements.
- Inability to take corticoids.
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.
- 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
Overall Response Rate
Trial terminated - results not analyzed
Secondary Outcome Measures
Overall Survival
Trial terminated - results not analyzed
Progression Free Survival
Trial terminated - results not analyzed
Duration of Response
Trial terminated - results not analyzed
Stable Disease Rate
Trial terminated - results not analyzed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00475657
Brief Title
Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer
Official Title
Phase II Study of Pemetrexed Plus Cisplatin in the Treatment of Patients With Extensive Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to lack of efficacy
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 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 if cisplatin and pemetrexed are effective in the treatment of patients with Small Cell Lung Cancer, extended disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (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
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
75 mg/m2, intravenous (IV), every 21 days x 6 cycles
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
Trial terminated - results not analyzed
Time Frame
baseline to measured progressive disease
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Trial terminated - results not analyzed
Time Frame
baseline to date of death from any cause
Title
Progression Free Survival
Description
Trial terminated - results not analyzed
Time Frame
baseline to measured progressive disease
Title
Duration of Response
Description
Trial terminated - results not analyzed
Time Frame
time of response to progressive disease
Title
Stable Disease Rate
Description
Trial terminated - results not analyzed
Time Frame
baseline to measured progressive disease
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologic or cytologic diagnosis of Small Cell Lung Cancer (SCLC).
Functional stage from 0 to 2 of the ECOG functional scale
No previous systemic chemotherapy, immunotherapy or biologic therapy for SCLC.
Previous bone marrow radiotherapy less than 25% is allowed.
There must be at least one measurable lesion that complies with the solid tumor response evaluation criteria.
Appropriate organic function.
Life expectancy estimated at 12 weeks minimum.
Females must be surgically sterile, postmenopausal or follow approved medical contraceptive methods during the treatment period and 6 months afterwards. Males must be surgically sterile or use a contraceptive method during the treatment period and during 6 months after treatment.
The patient must be compliant and located close to the trial area for appropriate follow-up.
The patient or his/her legal representative must sign an informed consent document.
Patients must be at least 18 years of age.
Exclusion Criteria:
Having received treatment for the last 30 days with a drug that has not obtained regulatory approval.
Having participated in a previous pemetrexed trial.
Mixed histologic diagnosis of SCLC and NSCLC.
Concurrent illness.
Having an active infection.
Severe cardiac disease.
Having received recently or concurrently a vaccine against yellow fever.
Having suffered a previous malignant process other than SCLC.
Central nervous system (CNS) metastases require concurrent corticoid therapy. Treated and stable CNS metastases are allowed.
Clinically relevant fluid accumulation in the third space.
Significant weight loss (greater than or equal to 10%) within 6 weeks prior to trial inclusion.
Concurrent administration of any other anti-tumor treatment.
Severe renal failure.
Unable to discontinue administration of non-steroidal anti-inflammatory (NSAIDS) agents.
Inability or unwillingness to take folic acid and vitamin B12 supplements.
Inability to take corticoids.
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
Ferrol
ZIP/Postal Code
15405
Country
Spain
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
La Coruña
ZIP/Postal Code
15002
Country
Spain
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
Lugo
ZIP/Postal Code
27004
Country
Spain
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
Ourense
ZIP/Postal Code
15009
Country
Spain
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
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
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
Vigo
ZIP/Postal Code
36211
Country
Spain
12. IPD Sharing Statement
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Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer
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