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Vandetanib, Carboplatin, and Paclitaxel in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Can Be Removed by Surgery

This study has been terminated.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Shirish Gadgeel, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00459121
First received: April 9, 2007
Last updated: April 3, 2013
Last verified: February 2013
History of Changes
Results First Received: November 12, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Drug: carboplatin
Drug: paclitaxel
Drug: Zactima
Procedure: neoadjuvant therapy

  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
Unable to enroll patients in a timely fashion. The decision was made to close the study after consulting with AstraZeneca.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Feasibility and safety.

Reporting Groups
  Description
Zactima, Paclitaxel, Carboplatin

Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.

Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment.

Participant Flow:   Overall Study
    Zactima, Paclitaxel, Carboplatin  
STARTED     2  
COMPLETED     2  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Zactima, Paclitaxel, Carboplatin

Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.

Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment.

Baseline Measures
    Zactima, Paclitaxel, Carboplatin  
Number of Participants  
[units: participants]
 		  2  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  56.5  ± 0  
Gender  
[units: participants]
 		 
Female     2  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     2  



  Outcome Measures

1.  Primary:   Complete Resection (R0) Rate   [ Time Frame: Following three cycles of pre-operative zactima and carboplatin/paclitaxel ]
  Show Outcome Measure 1

2.  Secondary:   Post-Operative Mortality Rate   [ Time Frame: at 30 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Assess Toxicity of This Regimen and the Percentage of Patients Completing All Planned Cycles of Therapy   [ Time Frame: Weekly for the first cycle; Thereafter within 72 hours of each dose of carboplatin/paclitaxel ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Assess the Clinical Response Rate of the Proposed Pre-operative Regimen   [ Time Frame: End of three cycles of treatment ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Assess the Complete Pathologic Complete Response (CR) Rate With This Regimen.   [ Time Frame: 30 days post surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
This was a single center study. We did not accrue enough particpants in a timely fashion and a joint decision was made with AstraZeneca to terminate the study.  


Results Point of Contact:  
Name/Title: Shirish Gadgeel, M.D.
Organization: Barbara Ann Karmanos Cancer Institute
phone: 313-576-8753
e-mail: gadgeels@karmanos.org


No publications provided


Responsible Party: Shirish Gadgeel, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00459121     History of Changes
Other Study ID Numbers: CDR0000539273, P30CA022453, WSU-2006-122, WSU-011807MP2F, WSU-0612004427, ZENECA-IRUSZACT0029
Study First Received: April 9, 2007
Results First Received: November 12, 2012
Last Updated: April 3, 2013
Health Authority: United States: Food and Drug Administration