Sunitinib and Erlotinib in Treating Patients With Unresectable or Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00425386
First received: January 19, 2007
Last updated: March 19, 2015
Last verified: March 2015
Results First Received: January 12, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kidney Cancer
Interventions: Drug: erlotinib hydrochloride
Drug: sunitinib malate
Procedure: biopsy

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The discrepancy between the number of participants enrolled (60) and the number of participants Started in the Participant Flow module (46) is due to screen failures and consent withdrawals.

Reporting Groups
  Description
Sunitinib and Erlotinib

Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;

  1. 100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
  2. 150 mg/day, continuous daily

Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off


Participant Flow:   Overall Study
    Sunitinib and Erlotinib  
STARTED     46  
COMPLETED     43  
NOT COMPLETED     3  



  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.
The discrepancy between the number of participants enrolled (60) and the number of participants Started in the Participant Flow module (46) is due to screen failures and consent withdrawals.

Reporting Groups
  Description
Sunitinib and Erlotinib

Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;

  1. 100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
  2. 150 mg/day, continuous daily

Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off


Baseline Measures
    Sunitinib and Erlotinib  
Number of Participants  
[units: participants]
  46  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     33  
>=65 years     13  
Age  
[units: years]
Median (Full Range)
  58  
  (24 to 78)  
Gender  
[units: participants]
 
Female     9  
Male     37  
Region of Enrollment  
[units: participants]
 
United States     46  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) of Erlotinib Hydrochloride When Used in Combination With Sunitinib.   [ Time Frame: Participants assessed for DLTs weekly during the first cycle of treatment and every 3 weeks in subsequent cycles until at least one DLT occurs in 33% or more of participants at that dose; participants assessed for the duration of the study, up to 7 years ]

2.  Primary:   Progression-free Survival at 8 Months   [ Time Frame: 8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney ]

3.  Secondary:   To Determine the Safety of Sunitinib in Combination With Erlotinib   [ Time Frame: For the duration of the study, up to 7 years ]

4.  Secondary:   Median Time to Progression   [ Time Frame: For the duration of the study, up to 7 years ]

5.  Secondary:   Proportion of Patients Whose Best Overall Response is Complete Response, Partial Response, Stable Disease, or Progressive Disease   [ Time Frame: From the start of treatment until the criteria for response is met. ]

6.  Secondary:   Maximum Percent Change in Tumor Measurement   [ Time Frame: Baseline through end of study, up to 7 years ]


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


Results Point of Contact:  
Name/Title: Dr. Christopher Ryan
Organization: OHSU Knight Cancer Institute
phone: 5034946197
e-mail: ryanc@ohsu.edu


Publications of Results:
Ryan CW, Curti BD, Pattee KJ, et al.: A dose-escalation phase II study of sunitinib (S) plus erlotinib (E) in advanced renal carcinoma (RCC). [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-361, 2008.


Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00425386     History of Changes
Other Study ID Numbers: CDR0000526204
P30CA069533 ( US NIH Grant/Contract Award Number )
OHSU-2683 ( Other Identifier: Oregon Health & Science University IRB )
OHSU-SOL-06051-LM ( Other Identifier: OHSU Knight Cancer Institute )
Study First Received: January 19, 2007
Results First Received: January 12, 2012
Last Updated: March 19, 2015
Health Authority: United States: Federal Government