Chemotherapy With Pemetrexed in Combination With Platinum for Advanced Non-Small Cell Lung Cancer (NSCLC)
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| ClinicalTrials.gov Identifier: NCT00402051 |
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Recruitment Status :
Completed
First Posted : November 22, 2006
Results First Posted : January 7, 2010
Last Update Posted : February 17, 2010
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Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
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Brief Summary:
This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be included in about 15 centers in Germany and randomized to one of the above treatment regimens in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a standard length of 21 days. Primary objective will be the Progression Free Survival Time of patients as assessed in both treatment arms.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-Small-Cell Lung Cancer | Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 133 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin in the First Line Therapy of Advanced NSCLC |
| Study Start Date : | November 2006 |
| Actual Primary Completion Date : | December 2008 |
| Actual Study Completion Date : | May 2009 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
| Experimental: Pemetrexed + Cisplatin |
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
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| Experimental: Pemetrexed + Carboplatin |
Drug: Pemetrexed
500 mg/m2, intravenous (IV), every 21 days x 6 cycles
Other Names:
Drug: Carboplatin
Area under the concentration curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
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Primary Outcome Measures :
- Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate) [ Time Frame: Randomization to Month 6 ]
Secondary Outcome Measures :
- Overall Survival [ Time Frame: Randomization to date of death from any cause (up to 1 year) ]
- Number of Participants With Tumor Response (as Basis for Response Rate) [ Time Frame: Every 6 weeks for 6 months during the treatment period, and every 3 months during the follow-up period, until disease progression ]
- Time to Treatment Failure (TTF) [ Time Frame: Randomization to stopping of treatment, progression, death or initiation of further chemotherapy, whichever occurs first (up to 1 year) ]
- Pharmacology Toxicities [ Time Frame: Every 21-day cycle for up to 6 cycles ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Cytologically and/or histologically confirmed NSCLC Stage IIIb or IV
- No previous systemic chemotherapy for this cancer
- At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria In Solid Tumors (RECIST) criteria
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1 and adequate organ function
- Prior radiation therapy allowed but limited to <25% of the patient's bone marrow
Exclusion Criteria:
- Serious concomitant systemic disorder or active infection
- Mild to moderate renal insufficiency, but unable to interrupt salicylates or other nonsteroidal anti-inflammatory drugs
- Symptomatic central nervous system (CNS) metastases requiring concurrent corticosteroid therapy
- Presence of clinically significant third-space fluid collections
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): NCT00402051
Locations
| Germany | |
| 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. | |
| Coswig, Germany, D-01640 | |
| 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. | |
| Frankfurt, Germany, 65929 | |
| 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. | |
| Großhansdorf, Germany, D-22927 | |
| 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. | |
| Halle, Germany, D-06120 | |
| 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. | |
| Hamburg, Germany, D-21075 | |
| 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. | |
| Hofheim, Germany, D-65719 | |
| 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. | |
| Homburg/Saar, Germany, 66421 | |
| 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. | |
| Immenhausen, Germany, D-34376 | |
| 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. | |
| Leipzig, Germany, 04207 | |
| 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. | |
| Luebeck, Germany, 23538 | |
| 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. | |
| Mainz, Germany, 55131 | |
| 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. | |
| Muenchen, Germany, 81664 | |
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: | NCT00402051 History of Changes |
| Other Study ID Numbers: |
11077 H3E-SB-S109 ( Other Identifier: Eli Lilly and Company ) |
| First Posted: | November 22, 2006 Key Record Dates |
| Results First Posted: | January 7, 2010 |
| Last Update Posted: | February 17, 2010 |
| Last Verified: | February 2010 |
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 Cisplatin Carboplatin Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |