Chemotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00391274 |
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Recruitment Status :
Completed
First Posted : October 23, 2006
Results First Posted : March 30, 2010
Last Update Posted : April 12, 2011
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Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
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Brief Summary:
The purpose of this study is to compare the efficacy and toxicity of pemetrexed and docetaxel administered on a 3-weekly schedule in the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have had prior chemotherapy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Small Cell Lung Cancer | Drug: pemetrexed Drug: docetaxel | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 211 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase 3 Study of Pemetrexed Versus Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy |
| Study Start Date : | October 2006 |
| Actual Primary Completion Date : | December 2008 |
| Actual Study Completion Date : | June 2010 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
| Arm | Intervention/treatment |
|---|---|
| Experimental: Pemetrexed |
Drug: pemetrexed
500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment
Other Names:
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| Active Comparator: Docetaxel |
Drug: docetaxel
75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment |
Primary Outcome Measures :
- Overall Survival [ Time Frame: baseline to date of death from any cause (up to 24 months after study enrollment); amendment (up to 30 months after study enrollment) ]Overall survival was defined as the time from the date of study enrollment to the date of death due to any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. An amendment allowed for the collection of overall survival on an additional 43 survival events. At the time the original record was released, it was not possible to provide results with the 95% Confidence Interval (CI) since the upper limit was not calculable. The median and 95% CIs are now reported.
Secondary Outcome Measures :
- Overall Tumor Response [ Time Frame: baseline to measured tumor response (up to 24 months after study enrollment) ]Response based on Response Evaluation Criteria In Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions; SD (stable disease) = small changes that do not meet above criteria.
- Progression-Free Survival (PFS) [ Time Frame: baseline to measured progressive disease (up to 24 months after study enrollment) ]Progression-free survival (PFS) time was defined as the time from the date of study enrollment to the date of the first of the following events: objective disease progression or death due to any cause. For patients who were alive and had not progressed, PFS was censored at the last contact.
- Duration of Response [ Time Frame: time of response to progressive disease (up to 24 months) ]Duration of tumor response is the duration from date of first objective status assessment of a complete or partial response to the first date of progression or death from any cause. For each patient who is not known to have died or to have had a progression of disease as of the data inclusion cut-off date, duration of tumor response was censored at the time of last prior contact. Due to the low number of patients in the analysis, the median duration of tumor response could not be calculated for the docetaxel arm. Available data are presented as "Number of Patients with Disease Progression".
- Pharmacology Toxicity [ Time Frame: first dose of study drug up to 24 months ]Maximum common terminology criteria (CTC) Grade 3 or 4 toxicities possibly related to study drug are reported. The worst grade event per cycle is reported. Grades range from 0 (none) to 5 (death). Grade 3 events are severe and Grade 4 events are life-threatening.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologic or cytologic diagnosis NSCLC (Stage IIIA, IIIB, or IV), not amenable to curative surgery or radiotherapy
- At least one prior chemotherapy for palliative therapy
- Response Evaluation Criteria In Solid Tumors (RECIST) criteria for disease status assessment
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Exclusion Criteria:
- Concurrent administration of any other tumor therapy
- Pregnant or breast feeding
- Serious concomitant disorders
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00391274
Locations
| 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. | |
| Beijing, China, 101149 | |
| 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. | |
| Guang Zhou, China, 510080 | |
| 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. | |
| Hang Zhou, China, 310022 | |
| 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. | |
| Nan Jing, China, 210002 | |
| 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. | |
| Shanghai, China, 200433 | |
| 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. | |
| Tianjin, China, 300060 | |
| 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. | |
| Wu Han, China, 430030 | |
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 |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00391274 History of Changes |
| Other Study ID Numbers: |
10717 H3E-MC-JMID ( Other Identifier: Eli Lilly and Company ) |
| First Posted: | October 23, 2006 Key Record Dates |
| Results First Posted: | March 30, 2010 |
| Last Update Posted: | April 12, 2011 |
| Last Verified: | April 2011 |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Docetaxel Pemetrexed Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |