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A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00887159
First received: April 22, 2009
Last updated: September 30, 2016
Last verified: June 2016
Results First Received: July 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Extensive Stage Small Cell Lung Carcinoma
Recurrent Small Cell Lung Carcinoma
Interventions: Drug: Cisplatin
Biological: Cixutumumab
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Drug: Vismodegib

  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
Participants were recruited from ECOG member institutions between July, 16, 2009 and August 12, 2011.

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
Arm A (CE)

Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

cisplatin: Given IV

etoposide: Given IV

Arm B (CE+GDC-0449)

Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.

vismodegib: Given PO

cisplatin: Given IV

etoposide: Given IV

Arm C (CE+IMC-A12)

Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

cisplatin: Given IV

etoposide: Given IV


Participant Flow:   Overall Study
    Arm A (CE)   Arm B (CE+GDC-0449)   Arm C (CE+IMC-A12)
STARTED   56   56   56 
Patients Who Started Assigned Treatment   53   53   52 
Eligible and Treated Patients   48   52   52 
Eligible/Treated Pts With CTCs Results   40   42   38 
COMPLETED   27   0 [1]   0 [1] 
NOT COMPLETED   29   56   56 
Disease progression                6                39                33 
Adverse Event                3                4                17 
Death                2                2                0 
Withdrawal by Subject                4                4                2 
Alternative therapy                2                0                0 
Physician Decision                1                1                0 
Sympomatic deterioration                1                0                0 
Treatment delayed                1                1                0 
Pt had PD but was SD when re-measured                0                1                0 
Received more tx instead of observation                1                0                0 
Ineligible                5                1                0 
Never started assigned therapy                3                3                4 
[1] Treatment continued until disease progression or unacceptable toxicity.



  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.
Eligible and treated patients.

Reporting Groups
  Description
Arm A (CE)

Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

cisplatin: Given IV

etoposide: Given IV

Arm B (CE+GDC-0449)

Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.

vismodegib: Given PO

cisplatin: Given IV

etoposide: Given IV

Arm C (CE+IMC-A12)

Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.

cixutumumab: Given IV

cisplatin: Given IV

etoposide: Given IV

Total Total of all reporting groups

Baseline Measures
   Arm A (CE)   Arm B (CE+GDC-0449)   Arm C (CE+IMC-A12)   Total 
Overall Participants Analyzed 
[Units: Participants]
 48   52   52   152 
Age 
[Units: Years]
Median (Full Range)
 61 
 (38 to 77) 
 64 
 (52 to 87) 
 64 
 (45 to 83) 
 63 
 (38 to 87) 
Gender 
[Units: Participants]
       
Female   25   26   25   76 
Male   23   26   27   76 
Region of Enrollment 
[Units: Participants]
       
United States   48   52   52   152 


  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry ]

2.  Secondary:   Response Rate   [ Time Frame: Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry ]

3.  Secondary:   Overall Survival (OS)   [ Time Frame: Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry ]

4.  Secondary:   PFS   [ Time Frame: Assessed every 6 weeks while on treatment or observation; follow-up after discontinuation of treatment or observation: every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry ]


  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 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.
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: Study statistician
Organization: ECOG-ACRIN Statistical Office
phone: 617-632-6012



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00887159     History of Changes
Other Study ID Numbers: NCI-2011-01917
NCI-2011-01917 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ECOG-E1508
CDR0000640898
E1508 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
E1508 ( Other Identifier: CTEP )
U10CA180820 ( US NIH Grant/Contract Award Number )
U10CA021115 ( US NIH Grant/Contract Award Number )
Study First Received: April 22, 2009
Results First Received: July 1, 2015
Last Updated: September 30, 2016
Health Authority: United States: Food and Drug Administration