Chemotherapy With Pemetrexed in Combination With Platinum for Advanced Non-Small Cell Lung Cancer (NSCLC)
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00402051
First received: November 17, 2006
Last updated: February 1, 2010
Last verified: February 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Non-Small-Cell Lung Cancer |
Drug: Pemetrexed Drug: Cisplatin Drug: Carboplatin |
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: | A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin in the First Line Therapy of Advanced NSCLC |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate) [ Time Frame: Randomization to Month 6 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall Survival [ Time Frame: Randomization to date of death from any cause (up to 1 year) ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
- Pharmacology Toxicities [ Time Frame: Every 21-day cycle for up to 6 cycles ] [ Designated as safety issue: Yes ]
| Enrollment: | 133 |
| Study Start Date: | November 2006 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
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: NCT00402051
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
Additional Information:
No publications provided by Eli Lilly and Company
Additional 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 |
| Study First Received: | November 17, 2006 |
| Results First Received: | November 30, 2009 |
| Last Updated: | February 1, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Carboplatin |
Cisplatin Pemetrexed Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015