Pemetrexed and Cisplatin as Treatment in Small Cell Lung Cancer
This study has been terminated.
(Terminated due to lack of efficacy)
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00475657
First received: May 16, 2007
Last updated: May 22, 2009
Last verified: May 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Small Cell Lung Cancer |
Drug: pemetrexed Drug: cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Pemetrexed Plus Cisplatin in the Treatment of Patients With Extensive Small Cell Lung Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Overall Response Rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall Survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
- Progression Free Survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
- Duration of Response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
- Stable Disease Rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
| Enrollment: | 5 |
| Study Start Date: | October 2007 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
Other Names:
Drug: cisplatin
75 mg/m2, intravenous (IV), every 21 days x 6 cycles
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475657
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475657
Locations
| Spain | |
| 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. | |
| Ferrol, Spain, 15405 | |
| 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. | |
| La Coruña, Spain, 15002 | |
| 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. | |
| Lugo, Spain, 27004 | |
| 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. | |
| Ourense, Spain, 15009 | |
| 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. | |
| Santiago de Compostela, Spain, 15706 | |
| 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. | |
| Vigo, Spain, 36211 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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) | Eli Lilly and Company |
More Information
Additional Information:
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00475657 History of Changes |
| Other Study ID Numbers: | 11473 H3E-XM-S113 |
| Study First Received: | May 16, 2007 |
| Results First Received: | March 31, 2009 |
| Last Updated: | May 22, 2009 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Cisplatin Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on September 30, 2016