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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
Enrollment 60
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Sunitinib and Erlotinib
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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

Period Title: Overall Study
Started 46
Completed 43
Not Completed 3
Arm/Group Title Sunitinib and Erlotinib
Hide Arm/Group Description

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

Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
<=18 years
0
   0.0%
Between 18 and 65 years
33
  71.7%
>=65 years
13
  28.3%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 46 participants
58
(24 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
9
  19.6%
Male
37
  80.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants
46
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of Erlotinib Hydrochloride When Used in Combination With Sunitinib.
Hide Description The MTD is defined as the dose that produces dose limiting toxicity (DLT) in 33% of the patients.
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
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[Not Specified]
Arm/Group Title Sunitinib and Erlotinib
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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

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: milligrams
Sunitinib 50
Erlotinib 150
2.Primary Outcome
Title Progression-free Survival at 8 Months
Hide Description Defined as the proportion of patients who are progression free (CR, PR and SD) at 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. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR)= At least a 30% decrease in the sum of the longest diameter of target lesions, and Stable Disease (SD)= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (20% increase in the sum).
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
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib and Erlotinib
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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

Overall Number of Participants Analyzed 46
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40
(23 to 56)
3.Secondary Outcome
Title To Determine the Safety of Sunitinib in Combination With Erlotinib
Hide Description [Not Specified]
Time Frame For the duration of the study, up to 7 years
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib and Erlotinib
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: participants
Diarrhea 35
Rash 35
Fatigue 30
Dysguesia 29
Nausea 21
Anorexia 15
Vomitting 14
Hand-foot syndrome 13
Stomatitis 13
Weight loss 13
Constipation 12
Dyspepsia 12
Dry skin 10
Alopecia 9
Pruritus 9
Other skin/hair changes 8
Dehydration 5
4.Secondary Outcome
Title Median Time to Progression
Hide Description The Kaplan-Meier method will be used to estimate the median time to progression.
Time Frame For the duration of the study, up to 7 years
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib and Erlotinib
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 46
Median (95% Confidence Interval)
Unit of Measure: months
5.8
(4.1 to 9.7)
5.Secondary Outcome
Title Proportion of Patients Whose Best Overall Response is Complete Response, Partial Response, Stable Disease, or Progressive Disease
Hide Description [Not Specified]
Time Frame From the start of treatment until the criteria for response is met.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib and Erlotinib
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: percentage of participants
Partial Response 22
Stable Disease 59
Progressive Disease 11
6.Secondary Outcome
Title Maximum Percent Change in Tumor Measurement
Hide Description The maximum percent change in Tumor Measurement is the greatest percent change in longest diameter (LD) for the target lesions from the baseline LD. For patients with no change in LD, the maximum percent change is the lowest increase in LD from the baseline LD.
Time Frame Baseline through end of study, up to 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib and Erlotinib
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 46
Mean (Full Range)
Unit of Measure: percent change in size
18
(-100 to 94)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sunitinib and Erlotinib
Hide Arm/Group Description

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

All-Cause Mortality
Sunitinib and Erlotinib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib and Erlotinib
Affected / at Risk (%)
Total   7/46 (15.22%) 
Blood and lymphatic system disorders   
Hypomagnesemia   1/46 (2.17%) 
Gastrointestinal disorders   
Abdominal Aortic Aneurysm   1/46 (2.17%) 
General disorders   
Disease Progression   1/46 (2.17%) 
Renal and urinary disorders   
Hematuria   1/46 (2.17%) 
Carcinoma of Prostatic Urethra   1/46 (2.17%) 
Respiratory, thoracic and mediastinal disorders   
Spontaneous Pneumothorax   1/46 (2.17%) 
Skin and subcutaneous tissue disorders   
Angioedema   1/46 (2.17%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sunitinib and Erlotinib
Affected / at Risk (%)
Total   46/46 (100.00%) 
Gastrointestinal disorders   
Diarrhea   35/46 (76.09%) 
Dysguesia   29/46 (63.04%) 
Nausea   21/46 (45.65%) 
Anorexia   15/46 (32.61%) 
Vomitting   14/46 (30.43%) 
Stomatitis   13/46 (28.26%) 
Constipation   12/46 (26.09%) 
Dyspepsia   12/46 (26.09%) 
Dehydration   5/46 (10.87%) 
General disorders   
Fatigue   30/46 (65.22%) 
Weight loss   13/46 (28.26%) 
Skin and subcutaneous tissue disorders   
Rash   35/46 (76.09%) 
Hand-foot syndrome   13/46 (28.26%) 
Dry skin   10/46 (21.74%) 
Alopecia   9/46 (19.57%) 
Pruritus   9/46 (19.57%) 
Other skin/hair changes   8/46 (17.39%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Christopher Ryan
Organization: OHSU Knight Cancer Institute
Phone: 5034946197
EMail: 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.
Layout table for additonal information
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