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

Phase 2CompletedNCT00482014

Eli Lilly and Company120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Non-Small-Cell Lung Cancer

Interventions

pemetrexedDRUG

Phase 1 - 500 milligram/meter squared (mg/m²), administered intravenously, every 21 days for 3 cycles Phase 2 - 500 mg/m², administered intravenously, every 21 days for 3 cycles Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation therapy for each phase

cisplatinDRUG

Phase 1 - 30 mg/m² and 75 mg/m², administered intravenously, Days 1, 8, 22, 29 and 43 Phase 2 - 75 mg/m², administered intravenously, every 21 days for 3 cycles

carboplatinDRUG

Phase 1 - dosed at area under the curve (AUC) 2 milligram/milliliter\*minute (mg/mL\*min), administered intravenously, Days 1, 8, 22, 29 and 43 Phase 2 - dosed at AUC 5 mg/mL\*min, administered intravenously, every 21 days for 3 cycles

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Outcomes

Primary Outcomes

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).

Time frame: Phase 1 enrollment to the end of study treatment up to Week 11

Phase 1 - Maximum Tolerated Dose (MTD) of Cisplatin

Time frame: Phase 1 enrollment to the end of study treatment up to Week 11

Phase 2 - Survival Probability at 2 Years

Time frame: Phase 2 randomization up to 2 years

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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radiation therapyRADIATION

Phase 1 - 2 Gray, daily, 5 days a week for Days 1-51 Phase 2 - 2 Gray, daily, 5 days a week for Days 1-45

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

Wichita, Kansas, United States

St Louis, Missouri, United States

Las Vegas, Nevada, United States

Burlington, North Carolina, United States

Memphis, Tennessee, United States

Corpus Christi, Texas, United States

Dallas, Texas, United States

Temple, Texas, United States

Delhi, India

...and 1 more locations

Time frame: Phase 1 enrollment up to Week 11

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.

Time frame: Phase 1 enrollment to the end of the study treatment up to Week 11

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.

Time frame: Phase 2 randomization to the end of the study treatment up to 30.0 months

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.

Time frame: Phase 2 randomization to measured disease progression up to 24 months

Phase 2 - Median Survival

Time frame: 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)

Time frame: Phase 2 randomization to the end of the treatment up to 30.0 months