A Single Arm Phase 2 Study of Pemetrexed as 2nd-Line Treatment of Advanced Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190840
First received: September 12, 2005
Last updated: January 24, 2007
Last verified: January 2007
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Purpose
In previous phase 2 studies, pemetrexed has shown antitumor activity in advanced non-small cell lung cancer as a single agent as well as in combination with cisplatin. Since the introduction of vitamin supplementation, pemetrexed has shown good tolerance and high safety. Vitamin supplementation has opened the opportunity to offer patients higher pemetrexed dosing, as has been demonstrated by a recent Phase 1 study. The higher dose with supplementation may increase pemetrexed's efficacy without unduly compromising safety. The present Phase 2 study will use pemetrexed dosing that is tailored to individual patient tolerance, and is an effort to determine the efficacy and safety of this approach in patients with advanced NSCLC who had prior chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Non-Small Cell Lung |
Drug: pemetrexed |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-Label Single-Arm Phase 2 Study of ALIMTA in Patients With Advanced Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Response rate according to RECIST criteria
Secondary Outcome Measures:
- To assess the following time to event efficacy variables:
- o Duration of overall response for responding patients
- o Time to progressive disease
- o Time to treatment failure
- o Survival
- To characterize the quantitative and qualitative toxicity of pemetrexed when used at tailored dosing in this patient population
| Estimated Enrollment: | 186 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | October 2005 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- diagnosis of NSCLC
- Locally advanced or metastatic disease (Stage IIIB or IV).
- Patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
- Disease status must be that of measurable disease as defined by RECIST criteria
- Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale; and adequate organ function.
Exclusion Criteria:
- Known or suspected brain metastasis, or Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
- Concurrent administration of any other tumor therapy.
- History of significant neurological or mental disorder, including seizures or dementia; or any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed.
- Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190840
Locations
| Australia, New South Wales | |
| 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. | |
| Wollongong, New South Wales, Australia, 2500 | |
| Australia, Queensland | |
| 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. | |
| Chermside, Queensland, Australia, 4032 | |
| Australia, South Australia | |
| 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. | |
| Ashford, South Australia, Australia, 5035 | |
| Australia, Victoria | |
| 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. | |
| Fitzroy, Victoria, Australia, 3065 | |
| China | |
| 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. | |
| Hong Kong, China | |
| Egypt | |
| 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. | |
| Alexandria, Egypt | |
| 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. | |
| Cairo, Egypt, 11796 | |
| India | |
| 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. | |
| Hyderabad, Andhra Pradesh, India, 500004 | |
| 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. | |
| Ludhiana, Punjab, India, 141001 | |
| 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. | |
| Chandigarh, India, 160012 | |
| 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. | |
| Chennai, India, 600035 | |
| 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. | |
| Delhi, India, 110085 | |
| Korea, Republic of | |
| 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. | |
| Goyang-Si, Gyeonggi-Do, Korea, Republic of, 411764 | |
| 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. | |
| Seoul, Korea, Republic of | |
| Romania | |
| 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. | |
| Oradea, Bihor, Romania, 3700 | |
| 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. | |
| Craiova, Dolj, Romania, 1100 | |
| 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. | |
| Bucuresti, Romania, 72435 | |
| 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. | |
| Iasi, Romania, 6600 | |
| Taiwan | |
| 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. | |
| Taipei, Taiwan | |
| Turkey | |
| 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. | |
| Eskisehir, Turkey | |
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: | NCT00190840 History of Changes |
| Other Study ID Numbers: | 6685, H3E-AA-S037 |
| Study First Received: | September 12, 2005 |
| Last Updated: | January 24, 2007 |
| Health Authority: | United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Egypt: Ministry of Health and Population Hong Kong: Department of Health India: Ministry of Health South Korea: Korea Food and Drug Administration (KFDA) Romania: National Medicine Agency Taiwan: Department of Health Turkey: Ministry of Health |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Lung Diseases Respiratory Tract Diseases 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