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

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. Identifier: NCT00447421
Recruitment Status : Terminated (Interim results of another trial showed inferior activity of treatment)
First Posted : March 14, 2007
Results First Posted : August 26, 2009
Last Update Posted : October 28, 2009
Information provided by:
Eli Lilly and Company

March 12, 2007
March 14, 2007
May 28, 2009
August 26, 2009
October 28, 2009
February 2007
May 2008   (Final data collection date for primary outcome measure)
  • Phase 1: Maximum Tolerated Dose [ Time Frame: every cycle ]
  • Phase 2: Overall Response Rate [ Time Frame: baseline to measured progressive disease ]
  • The recommended dose of cisplatin and pemetrexed and concurrent radiotherapy
  • The overall response rate
Complete list of historical versions of study NCT00447421 on Archive Site
  • 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 ]
Identification, interpretation and characterization of toxicities and overall response rate
Not Provided
Not Provided
A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy
Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer
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.
Not Provided
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Small Cell Lung Cancer
  • Carcinoma, Small Cell
  • SCLC
  • 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
Experimental: A
  • Drug: pemetrexed
  • Drug: cisplatin
  • Radiation: radiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2008
May 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Netherlands
Not Provided
Not Provided
Chief Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP