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Study Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143455
First received: September 1, 2005
Last updated: February 10, 2010
Last verified: February 2010
Results First Received: December 11, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Small Cell Lung Carcinoma
Interventions: Drug: Etoposide + cisplatin
Drug: Irinotecan + cisplatin

  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
Enrollment of Cohort 1 was terminated early per protocol amendment (29 September 2003). With limited number of subjects in Cohort 1, the efficacy analysis was exploratory. The amendment reduced Irinotecan dose from 80 to 65 mg/m2. With the study powered for Overall Survival in subjects recruited thereafter (Cohort 2) efficacy analysis is reported.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Irinotecan + Cisplatin (Cohort 1) Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
Etoposide + Cisplatin (Cohort 1) Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
Irinotecan + Cisplatin (Cohort 2) Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
Etoposide + Cisplatin (Cohort 2) Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.

Participant Flow for 2 periods

Period 1:   Cohort 1
    Irinotecan + Cisplatin (Cohort 1)     Etoposide + Cisplatin (Cohort 1)     Irinotecan + Cisplatin (Cohort 2)     Etoposide + Cisplatin (Cohort 2)  
STARTED     39     39     0     0  
Received Treatment     39     38     0     0  
COMPLETED     25     22     0     0  
NOT COMPLETED     14     17     0     0  
Adverse Event                 8                 4                 0                 0  
Death                 5                 2                 0                 0  
Progressive Disease                 0                 6                 0                 0  
Withdrawal by Subject                 1                 4                 0                 0  
Randomized But Not Treated                 0                 1                 0                 0  

Period 2:   Cohort 2
    Irinotecan + Cisplatin (Cohort 1)     Etoposide + Cisplatin (Cohort 1)     Irinotecan + Cisplatin (Cohort 2)     Etoposide + Cisplatin (Cohort 2)  
STARTED     0     0     203     204  
Received Treatment     0     0     202     203  
COMPLETED     0     0     97     111  
NOT COMPLETED     0     0     106     93  
Adverse Event                 0                 0                 42                 30  
No Longer Required Study Treatment                 0                 0                 1                 0  
Protocol Violation                 0                 0                 1                 1  
Lost to Follow-up                 0                 0                 1                 4  
Death                 0                 0                 20                 12  
Progressive Disease                 0                 0                 20                 27  
Withdrawal by Subject                 0                 0                 13                 12  
Unspecified                 0                 0                 7                 6  
Randomized But Not Treated                 0                 0                 1                 1  



  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
Irinotecan + Cisplatin (Cohort 1) Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
Etoposide + Cisplatin (Cohort 1) Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
Irinotecan + Cisplatin (Cohort 2) Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
Etoposide + Cisplatin (Cohort 2) Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
Total Total of all reporting groups

Baseline Measures
    Irinotecan + Cisplatin (Cohort 1)     Etoposide + Cisplatin (Cohort 1)     Irinotecan + Cisplatin (Cohort 2)     Etoposide + Cisplatin (Cohort 2)     Total  
Number of Participants  
[units: participants]
  39     38     202     203     482  
Age, Customized [1]
[units: participants]
         
18 to 44 years     2     1     11     6     20  
45 to 64 years     27     24     134     130     315  
> = 65 years     10     13     57     67     147  
Gender [1]
[units: participants]
         
Female     7     7     48     48     110  
Male     32     31     154     155     372  
[1] Protocol amendment (29 September 2003) reduced Irinotecan dose from 80 to 65mg/m2. Subjects recruited prior to amendment were referred to as Cohort 1; those afterwards were referred to as Cohort 2.



  Outcome Measures
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1.  Primary:   Overall Survival (OS) for the Full Analysis Population (FAP)   [ Time Frame: Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment) ]

2.  Primary:   Overall Survival for the Per Protocol (PP) Population   [ Time Frame: Baseline to date of death (every 3 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment) ]

3.  Secondary:   Number of Subjects With Overall Confirmed Response   [ Time Frame: Baseline to first documentation of confirmed response (every 9 weeks for up to 6 months on study treatment and every 2 months in follow up until progression) ]

4.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline to first documentation of confirmed response (every 9 weeks for up to 6 months on study treatment and every 2 months in follow up until progression) ]

5.  Secondary:   Time to Tumor Progression (TTP)   [ Time Frame: Baseline to date of progression (every 9 weeks for up to 6 months on study treatment and every 2 months for a minimum of 13 months post study treatment until progression) ]

6.  Secondary:   European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)   [ Time Frame: Baseline, at every cycle (Day -1, Day 1 of cycle before treatment), at the end of the treatment, and every 2 months during follow-up ]

7.  Secondary:   Tumor Related Symptoms (Pain, Dyspnea, Cough, Hemoptysis, Weight, and the Use of Opioids and Non-Opioids Analgesics)   [ Time Frame: Every 3 weeks for up to 6 months on study treatment ]


  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
No text entered.


  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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00143455     History of Changes
Other Study ID Numbers: XRP4174D-3001
Study First Received: September 1, 2005
Results First Received: December 11, 2009
Last Updated: February 10, 2010
Health Authority: Ireland: Irish Medicines Board