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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00425386
First received: January 19, 2007
Last updated: July 2, 2014
Last verified: July 2014
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
  Hide Participant Flow

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
No text entered.

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     60  
COMPLETED     44  
NOT COMPLETED     16  



  Baseline Characteristics
  Hide Baseline Characteristics

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
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]
  60  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     40  
>=65 years     20  
Age  
[units: years]
Mean ± Standard Deviation
  60.75  ± 10.6096  
Gender  
[units: participants]
 
Female     11  
Male     49  
Region of Enrollment  
[units: participants]
 
United States     60  



  Outcome Measures

1.  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 ]

2.  Primary:   Maximum Tolerated Dose (MTD) of Erlotinib Hydrochloride When Used in Combination With Sunitinib.   [ Time Frame: Evaluated at each dose level for the duration of the study. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   To Determine the Safety of Sunitinib in Combination With Erlotinib   [ Time Frame: For the duration of the study. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Median Time to Progression   [ Time Frame: For the duration of the study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

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. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Maximum Percent Reduction in Tumor Measurement   [ Time Frame: Baseline through end of study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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, OHSU-2683, OHSU-SOL-06051-LM
Study First Received: January 19, 2007
Results First Received: January 12, 2012
Last Updated: July 2, 2014
Health Authority: United States: Federal Government