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

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ClinicalTrials.gov Identifier: NCT00425386
Recruitment Status : Completed
First Posted : January 23, 2007
Results First Posted : February 16, 2012
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Christopher Ryan, OHSU Knight Cancer Institute

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Kidney Cancer
Interventions: Drug: erlotinib hydrochloride
Drug: sunitinib malate
Procedure: biopsy

  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
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

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 
Overall Participants Analyzed 
[Units: Participants]
 		 46 
Age 
[Units: Participants]
Count of Participants 		 
<=18 years      0   0.0% 
Between 18 and 65 years      33  71.7% 
>=65 years      13  28.3% 
Age 
[Units: Years]
Median (Full Range) 		 58 
 (24 to 78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      9  19.6% 
Male      37  80.4% 
Region of Enrollment 
[Units: Participants]
 		 
United States   46 


  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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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

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

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. ]
  Show Outcome Measure 5

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


  Serious Adverse Events


  Other Adverse Events


  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

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: Christopher Ryan, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00425386     History of Changes
Other Study ID Numbers: CDR0000526204
P30CA069533 ( U.S. NIH Grant/Contract )
OHSU-2683 ( Other Identifier: Oregon Health & Science University IRB )
OHSU-SOL-06051-LM ( Other Identifier: OHSU Knight Cancer Institute )
First Submitted: January 19, 2007
First Posted: January 23, 2007
Results First Submitted: January 12, 2012
Results First Posted: February 16, 2012
Last Update Posted: May 3, 2017