A Study of Pemetrexed in Small Cell Lung Cancer, Which Has Returned
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191750
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
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Purpose
The purposes of this study are to determine 1) the safety of pemetrexed and any side effects that might be associated with it 2) whether pemetrexed can help patients with small cell lung cancer live longer 3) whether pemetrexed can make tumors smaller or disappear and for how long and 4) to see if patients feel better while taking pemetrexed
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Small Cell |
Drug: Pemetrexed |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of ALIMTA in Relapsed Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- To assess the antitumor activity for patients with both sensitive and refractory small cell lung cancer patients as measured by tumor response rate. To characterize the toxicities of pemetrexed in this patient population
Secondary Outcome Measures:
- To better understand any side effects of pemetrexed
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | September 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of small cell lung cancer
- One prior treatment with chemotherapy or immunotherapy with greater than 3 weeks since the prior treatment
- At least 18 years of age
- Estimated life expectancy of at least 12 weeks
- Ambulatory and capable of self-care(eg, up and about greater than 50% of waking hours)
Exclusion Criteria:
- Have received treatment within the last 30 days with a drug that has not received FDA approval for any indication
- Less than 2 weeks from radiation therapy
- Other serious illness that would compromise the safety of the patient
- Most second primary malignancies treated less than 5 years previously
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00191750
Locations
| United States, Colorado | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Aurora, Colorado, United States | |
| United States, North Carolina | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Chapel Hill, North Carolina, United States | |
| United States, Texas | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | |
| Dallas, Texas, United States | |
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00191750 History of Changes |
| Other Study ID Numbers: | 7209, H3E-US-S069 |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 24, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Lung Neoplasms Small Cell Lung Carcinoma Carcinoma, Small Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Pemetrexed Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites |
ClinicalTrials.gov processed this record on May 19, 2013