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A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy

This study has been terminated.
(Interim results of another trial showed inferior activity of treatment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00447421
First Posted: March 14, 2007
Last Update Posted: October 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  Purpose
The purpose of this study is to determine the recommended dose of pemetrexed, cisplatin and radiotherapy in the treatment of patients with Small Cell Lung Cancer.

Condition Intervention Phase
Small Cell Lung Cancer Carcinoma, Small Cell SCLC Drug: pemetrexed Drug: cisplatin Radiation: radiation Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer
MedlinePlus related topics: Lung Cancer
Drug Information available for: Cisplatin Pemetrexed Pemetrexed disodium
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Phase 1: Maximum Tolerated Dose [ Time Frame: every cycle ]
  • Phase 2: Overall Response Rate [ Time Frame: baseline to measured progressive disease ]

Secondary Outcome Measures:
  • Phase 1: Best Overall Response [ Time Frame: baseline to measured response ]
  • Phase 2: Complete Response Rate [ Time Frame: baseline to measured response time ]
  • Phase 2: Time to Progressive Disease [ Time Frame: baseline to measured progressive disease ]
  • Phase 2: Duration of Response [ Time Frame: time of response to progressive disease ]
  • Phase 2: Overall Survival [ Time Frame: baseline to date of death from any cause ]
Enrollment: 9
Study Start Date: February 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: pemetrexed

Phase 1: 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)

Phase 2: 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles

Other Names:
  • LY231514
  • Alimta
Drug: cisplatin
Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles
Radiation: radiation
Phase 1 and Phase 2: 50-62 Gy, 25-31 days, cycles 2-4

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Measurable disease with diagnosis of Small Cell Lung Cancer.
  • Performance status of 0 to 1 on the Eastern Cooperative Oncology Group performance status schedule.
  • Patients must be at least 18 years of age and have at least a 12-week life expectancy.
  • No prior chemotherapy and/or prior thoracic radiotherapy.
  • Adequate pulmonary function and organ function.

Exclusion Criteria:

  • Patients with myocardial infarction within the preceding six months.
  • Diagnosis of a serious concomitant systemic disorder.
  • Prior radiotherapy to the lower neck or abdominal region.
  • Significant weight loss.
  • Concurrent administration of any other antitumor therapy.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447421


Locations
Belgium
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.
Leuven, Belgium, 3000
Netherlands
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.
Amsterdam, Netherlands, 1081 HV
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.
Den Bosch, Netherlands, 5211 NL
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.
Rotterdam, Netherlands, 3075 EA
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:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00447421     History of Changes
Other Study ID Numbers: 11089
H3E-EW-S107
First Submitted: March 12, 2007
First Posted: March 14, 2007
Results First Submitted: May 28, 2009
Results First Posted: August 26, 2009
Last Update Posted: October 28, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors


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