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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00482014
First received: May 31, 2007
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Non-Small-Cell Lung Cancer
Drug: pemetrexed
Drug: cisplatin
Drug: carboplatin
Radiation: radiation therapy
Phase 1
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: 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)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin [ Time Frame: Phase 1 enrollment to the end of study treatment up to Week 11 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Phase 1 enrollment to the end of study treatment up to Week 11 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Phase 2 randomization up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase 1 - Pharmacology Toxicity: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Phase 1 enrollment up to Week 11 ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Phase 1 enrollment to the end of the study treatment up to Week 11 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Phase 2 randomization to the end of the study treatment up to 30.0 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Phase 2 randomization to measured disease progression up to 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Phase 2 randomization to death as the result of any cause up to 30.0 month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 120
Study Start Date: May 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Pemetrexed + Carboplatin
Pemetrexed + Carboplatin
Drug: pemetrexed

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

Other Names:
  • LY231514
  • Alimta
Drug: carboplatin

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

Radiation: radiation therapy

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

Experimental: B: Pemetrexed + Cisplatin
Pemetrexed + Cisplatin
Drug: pemetrexed

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

Other Names:
  • LY231514
  • Alimta
Drug: cisplatin

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

Radiation: radiation therapy

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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00482014

Locations
United States, California
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, 90095
United States, Kansas
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, United States, 67214
United States, Missouri
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, 63110
United States, Nevada
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, 89135
United States, North Carolina
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, 27216
United States, Tennessee
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, 38120
United States, Texas
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, 78405
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, 75390
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, 76508
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, 110085
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, 695 011
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00482014     History of Changes
Other Study ID Numbers: 9031, H3E-US-S047
Study First Received: May 31, 2007
Results First Received: October 26, 2012
Last Updated: October 26, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Cisplatin
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 26, 2014