A Study of Pemetrexed Plus Carboplatin, or Pemetrexed Plus Cisplatin With Radiation Therapy Followed by Pemetrexed in Patients With Inoperable Non-Small-Cell Lung Cancer
- Conditions
- Non-Small-Cell Lung Cancer
- Interventions
- Registration Number
- NCT00482014
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A: Pemetrexed + Carboplatin carboplatin Pemetrexed + Carboplatin A: Pemetrexed + Carboplatin radiation therapy Pemetrexed + Carboplatin B: Pemetrexed + Cisplatin radiation therapy Pemetrexed + Cisplatin A: Pemetrexed + Carboplatin pemetrexed Pemetrexed + Carboplatin B: Pemetrexed + Cisplatin pemetrexed Pemetrexed + Cisplatin B: Pemetrexed + Cisplatin cisplatin Pemetrexed + Cisplatin
- Primary Outcome Measures
Name Time Method Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin Phase 1 enrollment to the end of study treatment up to Week 11 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 - Maximum Tolerated Dose (MTD) of Cisplatin Phase 1 enrollment to the end of study treatment up to Week 11 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 2 - Survival Probability at 2 Years Phase 2 randomization up to 2 years
- Secondary Outcome Measures
Name Time Method Phase 1 - Pharmacology Toxicity: Number of Participants With Dose Limiting Toxicities (DLTs) Phase 1 enrollment up to Week 11 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 - Percentage of Participants With Complete Response or Partial Response (Response Rate) Phase 1 enrollment to the end of the study treatment up to Week 11 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 - Pharmacology Toxicity: Number of Participants With Adverse Events Phase 2 randomization to the end of the study treatment up to 30.0 months 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 - Time to Progression Phase 2 randomization to measured disease progression up to 24 months 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 - Median Survival Phase 2 randomization to death as the result of any cause up to 30.0 month Phase 2 - Percentage of Participants With Complete Response or Partial Response (Response Rate) Phase 2 randomization to the end of the treatment up to 30.0 months 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.
Trial Locations
- Locations (1)
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, India