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A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00087711
First received: July 12, 2004
Last updated: November 21, 2016
Last verified: November 2016
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Purpose
This study is a randomized Phase 3 study comparing pemetrexed and cisplatin combination to gemcitabine and cisplatin for the treatment of Non Small Cell Lung Cancer (NCSLC). Gemcitabine plus cisplatin is currently the standard of care for NSCLC. It is thought that pemetrexed plus cisplatin may be as effective and may have fewer side effects than the standard of care.
| Condition | Intervention | Phase |
|---|---|---|
| Non Small Cell Lung Carcinoma | Drug: pemetrexed Drug: gemcitabine Drug: cisplatin | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Phase 3 Trial of ALIMTA and Cisplatin Versus GEMZAR and Cisplatin in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Cisplatin
Gemcitabine
Gemcitabine hydrochloride
Pemetrexed
Pemetrexed disodium
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Overall survival [ Time Frame: baseline to date of death from any cause ]
Secondary Outcome Measures:
- Progression free survival [ Time Frame: baseline to measured progressive disease ]
- Time to progressive disease [ Time Frame: baseline to measured progressive disease ]
- Duration of response [ Time Frame: time of response to progressive disease ]
- Time to treatment failure [ Time Frame: baseline to stopping treatment ]
| Enrollment: | 1713 |
| Study Start Date: | July 2004 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: pemetrexed
500 mg/m2, IV q 21 days x 6 cycles
Other Names:
Drug: cisplatin
75 mg/m2, IV, q 21 days x 6 cycles
|
| Active Comparator: B |
Drug: gemcitabine
1250 mg/m2, IV, day 1 and 8 q 21 days x 6 cycles
Other Names:
Drug: cisplatin
75 mg/m2, IV, q 21 days x 6 cycles
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of NSCLC Stage IIIB not amenable to curative treatment or Stage IV.
- No prior chemotherapy for lung cancer.
- Patients must have at least one uni-dimensionally measurable lesion.
- Prior radiation therapy to less than 25% of bone marrow, whole pelvis not allowed. Radiation must be completed at least 4 weeks prior to study enrollment.
Exclusion Criteria:
- Treatment with any drug within the last 30 days that has not received regulatory approval.
- Serious cardiac condition.
- Serious medical disorder in addition to NSCLC that would make it difficult for the patient to complete the study.
- Inability or unwillingness to take folic acid or Vitamin B12 supplementation.
- Presence of fluid retention that cannot be controlled by drainage.
Contacts and Locations
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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: NCT00087711
Show 134 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087711
Show 134 Study Locations
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 to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00087711 History of Changes |
| Other Study ID Numbers: |
2938 H3E-MC-JMDB ( Other Identifier: Eli Lilly and Company ) |
| Study First Received: | July 12, 2004 |
| Last Updated: | November 21, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement. |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Cisplatin Pemetrexed |
Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on July 21, 2017