Trial Outcomes & Findings for Sunitinib and Erlotinib in Treating Patients With Unresectable or Metastatic Kidney Cancer (NCT NCT00425386)
NCT ID: NCT00425386
Last Updated: 2017-05-03
Results Overview
The MTD is defined as the dose that produces dose limiting toxicity (DLT) in 33% of the patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
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
Results posted on
2017-05-03
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sunitinib and Erlotinib in Treating Patients With Unresectable or Metastatic Kidney Cancer
Baseline characteristics by cohort
| Measure |
Sunitinib and Erlotinib
n=46 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=93 Participants
|
|
Age, Continuous
|
58 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 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 yearsThe MTD is defined as the dose that produces dose limiting toxicity (DLT) in 33% of the patients.
Outcome measures
| Measure |
Sunitinib and Erlotinib
n=46 Participants
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
|
|---|---|
|
Maximum Tolerated Dose (MTD) of Erlotinib Hydrochloride When Used in Combination With Sunitinib.
Sunitinib
|
50 milligrams
|
|
Maximum Tolerated Dose (MTD) of Erlotinib Hydrochloride When Used in Combination With Sunitinib.
Erlotinib
|
150 milligrams
|
PRIMARY outcome
Timeframe: 8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidneyDefined 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).
Outcome measures
| Measure |
Sunitinib and Erlotinib
n=46 Participants
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
|
|---|---|
|
Progression-free Survival at 8 Months
|
40 percentage of participants
Interval 23.0 to 56.0
|
SECONDARY outcome
Timeframe: For the duration of the study, up to 7 yearsOutcome measures
| Measure |
Sunitinib and Erlotinib
n=46 Participants
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
|
|---|---|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Diarrhea
|
35 participants
|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Dehydration
|
5 participants
|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Rash
|
35 participants
|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Fatigue
|
30 participants
|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Dysguesia
|
29 participants
|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Nausea
|
21 participants
|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Anorexia
|
15 participants
|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Vomitting
|
14 participants
|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Hand-foot syndrome
|
13 participants
|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Stomatitis
|
13 participants
|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Weight loss
|
13 participants
|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Constipation
|
12 participants
|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Dyspepsia
|
12 participants
|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Dry skin
|
10 participants
|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Alopecia
|
9 participants
|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Pruritus
|
9 participants
|
|
To Determine the Safety of Sunitinib in Combination With Erlotinib
Other skin/hair changes
|
8 participants
|
SECONDARY outcome
Timeframe: For the duration of the study, up to 7 yearsThe Kaplan-Meier method will be used to estimate the median time to progression.
Outcome measures
| Measure |
Sunitinib and Erlotinib
n=46 Participants
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
|
|---|---|
|
Median Time to Progression
|
5.8 months
Interval 4.1 to 9.7
|
SECONDARY outcome
Timeframe: From the start of treatment until the criteria for response is met.Outcome measures
| Measure |
Sunitinib and Erlotinib
n=46 Participants
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
|
|---|---|
|
Proportion of Patients Whose Best Overall Response is Complete Response, Partial Response, Stable Disease, or Progressive Disease
Partial Response
|
22 percentage of participants
|
|
Proportion of Patients Whose Best Overall Response is Complete Response, Partial Response, Stable Disease, or Progressive Disease
Stable Disease
|
59 percentage of participants
|
|
Proportion of Patients Whose Best Overall Response is Complete Response, Partial Response, Stable Disease, or Progressive Disease
Progressive Disease
|
11 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through end of study, up to 7 yearsThe 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.
Outcome measures
| Measure |
Sunitinib and Erlotinib
n=46 Participants
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
|
|---|---|
|
Maximum Percent Change in Tumor Measurement
|
18 percent change in size
Interval -100.0 to 94.0
|
Adverse Events
Sunitinib and Erlotinib
Serious events: 7 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sunitinib and Erlotinib
n=46 participants at risk
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
|
|---|---|
|
Renal and urinary disorders
Hematuria
|
2.2%
1/46
|
|
General disorders
Disease Progression
|
2.2%
1/46
|
|
Respiratory, thoracic and mediastinal disorders
Spontaneous Pneumothorax
|
2.2%
1/46
|
|
Renal and urinary disorders
Carcinoma of Prostatic Urethra
|
2.2%
1/46
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
2.2%
1/46
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
2.2%
1/46
|
|
Gastrointestinal disorders
Abdominal Aortic Aneurysm
|
2.2%
1/46
|
Other adverse events
| Measure |
Sunitinib and Erlotinib
n=46 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
76.1%
35/46
|
|
Skin and subcutaneous tissue disorders
Rash
|
76.1%
35/46
|
|
General disorders
Fatigue
|
65.2%
30/46
|
|
Gastrointestinal disorders
Dysguesia
|
63.0%
29/46
|
|
Gastrointestinal disorders
Nausea
|
45.7%
21/46
|
|
Gastrointestinal disorders
Anorexia
|
32.6%
15/46
|
|
Gastrointestinal disorders
Vomitting
|
30.4%
14/46
|
|
Skin and subcutaneous tissue disorders
Hand-foot syndrome
|
28.3%
13/46
|
|
Gastrointestinal disorders
Stomatitis
|
28.3%
13/46
|
|
General disorders
Weight loss
|
28.3%
13/46
|
|
Gastrointestinal disorders
Constipation
|
26.1%
12/46
|
|
Gastrointestinal disorders
Dyspepsia
|
26.1%
12/46
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
21.7%
10/46
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.6%
9/46
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.6%
9/46
|
|
Skin and subcutaneous tissue disorders
Other skin/hair changes
|
17.4%
8/46
|
|
Gastrointestinal disorders
Dehydration
|
10.9%
5/46
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place