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
Results First Received: May 28, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Small Cell Lung Cancer
Carcinoma, Small Cell
SCLC
Interventions: Drug: pemetrexed
Drug: cisplatin
Radiation: radiation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a Phase 1/2 trial that was terminated during Phase 1 and never progressed to Phase 2. The number of patients enrolled is for the Phase 1 portion.

Reporting Groups
  Description
Pemetrexed + Cisplatin

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

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

Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles

Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4


Participant Flow:   Overall Study
    Pemetrexed + Cisplatin  
STARTED     9  
COMPLETED     3  
NOT COMPLETED     6  
Lack of Efficacy                 1  
Adverse Event                 3  
Sponsor Decision                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pemetrexed + Cisplatin

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

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

Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles

Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4


Baseline Measures
    Pemetrexed + Cisplatin  
Number of Participants  
[units: participants]
  9  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     5  
Gender  
[units: participants]
 
Female     3  
Male     6  
Region of Enrollment  
[units: participants]
 
Belgium     2  
Netherlands     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Phase 1: Maximum Tolerated Dose   [ Time Frame: every cycle ]

2.  Primary:   Phase 2: Overall Response Rate   [ Time Frame: baseline to measured progressive disease ]

3.  Secondary:   Phase 1: Best Overall Response   [ Time Frame: baseline to measured response ]

4.  Secondary:   Phase 2: Complete Response Rate   [ Time Frame: baseline to measured response time ]

5.  Secondary:   Phase 2: Time to Progressive Disease   [ Time Frame: baseline to measured progressive disease ]

6.  Secondary:   Phase 2: Duration of Response   [ Time Frame: time of response to progressive disease ]

7.  Secondary:   Phase 2: Overall Survival   [ Time Frame: baseline to date of death from any cause ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The Study Phase 1 was stopped early based on interim results of another trial, showing inferior activity of pemetrexed/carboplatin compared to etoposide/carboplatin in extensive small cell lung cancer. The Study did not progress to Phase 2.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00447421     History of Changes
Other Study ID Numbers: 11089, H3E-EW-S107
Study First Received: March 12, 2007
Results First Received: May 28, 2009
Last Updated: October 24, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)