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:
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 |
| 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
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:
No publications provided
| 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 Pemetrexed |
Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 21, 2013