Non-Small-Cell Lung Cancer Clinical Trial
Official title:
Phase 1/2 Study of Pemetrexed (Alimta) Plus Carboplatin, or Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Every-21-Day Pemetrexed Consolidation in Patients With Favorable-Prognosis Inoperable Stage IIIA/B Non-Small-Cell Lung Cancer (NSCLC)
Verified date | October 2012 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The primary purpose of this study is to determine the 2-year survival rate of both of the chemotherapy regimens in patients with inoperable non-small-cell lung cancer.
Status | Completed |
Enrollment | 120 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Inoperable non small cell lung cancer - No weight loss greater than 10% in 3 months prior to enrolling in trial - Adequate kidney function - Adequate liver function - Adequate lung function Exclusion Criteria: - Previous surgery to remove lung tumor - Previous chemotherapy or radiation therapy or lung cancer - Inability to take vitamin supplementation - Heart attack within past 6 months - Active infection |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
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. | Delhi | |
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. | Trivandrum | |
United States | 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. | Burlington | North Carolina |
United States | 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. | Corpus Christi | Texas |
United States | 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. | Dallas | Texas |
United States | 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. | Las Vegas | Nevada |
United States | 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. | Los Angeles | California |
United States | 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. | Memphis | Tennessee |
United States | 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. | St Louis | Missouri |
United States | 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. | Temple | Texas |
United States | 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. | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
United States, India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin | MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; =Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with =Grade 2 bleeding, =Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and =Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis). | Phase 1 enrollment to the end of study treatment up to Week 11 | Yes |
Primary | Phase 1 - Maximum Tolerated Dose (MTD) of Cisplatin | MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) lasting >7 days, febrile neutropenia; =Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with =Grade 2 bleeding, =Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and =Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis). | Phase 1 enrollment to the end of study treatment up to Week 11 | Yes |
Primary | Phase 2 - Survival Probability at 2 Years | Phase 2 randomization up to 2 years | No | |
Secondary | Phase 1 - Pharmacology Toxicity: Number of Participants With Dose Limiting Toxicities (DLTs) | Phase 1 pharmacology toxicity was defined as the number of participants experiencing dose limiting toxicities (DLTs). DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course: Grade 4 neutropenia (<0.5 x 10^9 cells per liter) >7 days, febrile neutropenia, =Grade 3 neutropenia with fever >38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with =Grade 2 bleeding, =Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations), and =Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis). Grade 5 events are the events leading to the death. | Phase 1 enrollment up to Week 11 | Yes |
Secondary | Phase 1 - Percentage of Participants With Complete Response or Partial Response (Response Rate) | Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is =30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. | Phase 1 enrollment to the end of the study treatment up to Week 11 | No |
Secondary | Phase 2 - Pharmacology Toxicity: Number of Participants With Adverse Events | Phase 2 pharmacology toxicity was defined as the number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Events section. | Phase 2 randomization to the end of the study treatment up to 30.0 months | Yes |
Secondary | Phase 2 - Time to Progression | Time to disease progression was measured from randomization of Study Phase 2 to the first observation of disease progression according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Disease progression is =20% increase in sum of longest diameter of target lesions and/or a new lesion. | Phase 2 randomization to measured disease progression up to 24 months | No |
Secondary | Phase 2 - Median Survival | Phase 2 randomization to death as the result of any cause up to 30.0 month | No | |
Secondary | Phase 2 - Percentage of Participants With Complete Response or Partial Response (Response Rate) | Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is =30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100. | Phase 2 randomization to the end of the treatment up to 30.0 months | No |
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