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:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00447421
First received: March 12, 2007
Last updated: October 24, 2009
Last verified: October 2009

March 12, 2007
October 24, 2009
February 2007
May 2008   (final data collection date for primary outcome measure)
  • Phase 1: Maximum Tolerated Dose [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Phase 2: Overall Response Rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • The recommended dose of cisplatin and pemetrexed and concurrent radiotherapy
  • The overall response rate
Complete list of historical versions of study NCT00447421 on ClinicalTrials.gov Archive Site
  • Phase 1: Best Overall Response [ Time Frame: baseline to measured response ] [ Designated as safety issue: No ]
  • Phase 2: Complete Response Rate [ Time Frame: baseline to measured response time ] [ Designated as safety issue: No ]
  • Phase 2: Time to Progressive Disease [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Phase 2: Duration of Response [ Time Frame: time of response to progressive disease ] [ Designated as safety issue: No ]
  • Phase 2: Overall Survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
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
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Interventions:
  • Drug: pemetrexed
  • Drug: cisplatin
  • Radiation: radiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Netherlands
 
NCT00447421
11089, H3E-EW-S107
No
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