Trial Outcomes & Findings for Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial Cancer (NCT NCT00749892)
NCT ID: NCT00749892
Last Updated: 2020-09-10
Results Overview
The response rate is the number of patients with urothelial cancer treated with erlotinib prior to cystectomy. The response is defined as the absence of residual cancer in the surgical removed tissue (i.e., pT0). A responder is defined as a participant with the pathological stage of pT0 meaning that there is no evidence of disease.
COMPLETED
PHASE2
34 participants
Determined at the time of surgery or cystectomy
2020-09-10
Participant Flow
Recruitment began 6/9/2008 and concluded on 12/19/2011 in the medical clinic. Diagnosis of invasive transitional cell carcinoma in the bladder, upper tract or urethra tumors were required for participants who were candidates for cystectomy to be considered. Participants with high-risk features were generally excluded.
Erlotinib treatment milestone: Three participants decided to not start the study medication.
Participant milestones
| Measure |
Pre-surgical Erlotinib Treatment
Erlotinib 150 mg by mouth daily for 3 weeks followed by cystectomy within 24 hours of the last dose.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Pre-surgical Erlotinib Treatment
Erlotinib 150 mg by mouth daily for 3 weeks followed by cystectomy within 24 hours of the last dose.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Three particpants withdrew from study treatment.
Baseline characteristics by cohort
| Measure |
Pre-surgical Erlotinib Treatment
n=34 Participants
Erlotinib 150 mg by mouth daily for 3 weeks followed by cystectomy within 24 hours of the last dose.
|
|---|---|
|
Age, Continuous
|
68 years
n=34 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=34 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=34 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=34 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=34 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=34 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=34 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=34 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=34 Participants
|
|
Clinical Staging
cTaN0
|
1 Participants
n=31 Participants • Three particpants withdrew from study treatment.
|
|
Clinical Staging
cT1N0
|
10 Participants
n=31 Participants • Three particpants withdrew from study treatment.
|
|
Clinical Staging
cT2N0
|
17 Participants
n=31 Participants • Three particpants withdrew from study treatment.
|
|
Clinical Staging
cT3aN0
|
1 Participants
n=31 Participants • Three particpants withdrew from study treatment.
|
|
Clinical Staging
cT3bN0
|
1 Participants
n=31 Participants • Three particpants withdrew from study treatment.
|
|
Clinical Staging
cT4aN0
|
1 Participants
n=31 Participants • Three particpants withdrew from study treatment.
|
PRIMARY outcome
Timeframe: Determined at the time of surgery or cystectomyPopulation: two participants did not take any eroltinib and three participants stopped erlotinib early due to intolerable side effects.
The response rate is the number of patients with urothelial cancer treated with erlotinib prior to cystectomy. The response is defined as the absence of residual cancer in the surgical removed tissue (i.e., pT0). A responder is defined as a participant with the pathological stage of pT0 meaning that there is no evidence of disease.
Outcome measures
| Measure |
Pre-surgical Erlotinib Treatment
n=26 Participants
Erlotinib 150 mg by mouth daily for 3 weeks followed by cystectomy within 24 hours of the last dose.
|
|---|---|
|
Response Rate
Number of Responders
|
8 Participants
|
|
Response Rate
Number of Non Responders
|
18 Participants
|
SECONDARY outcome
Timeframe: 4 yearsOutcome measures
Outcome data not reported
Adverse Events
Pre-surgical Erlotinib Treatment
Serious adverse events
| Measure |
Pre-surgical Erlotinib Treatment
n=31 participants at risk
Erlotinib 150 mg by mouth daily for 3 weeks followed by cystectomy within 24 hours of the last dose.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
2/31 • Evaluated for 2 months once drug therapy started.
Toxicities were measured at weekly visit while on therapy using the NCI CTCAE v3.0.
|
|
Blood and lymphatic system disorders
Decreased Neutrophils/Grabulocytes
|
3.2%
1/31 • Evaluated for 2 months once drug therapy started.
Toxicities were measured at weekly visit while on therapy using the NCI CTCAE v3.0.
|
|
Endocrine disorders
Adrenal insufficiency
|
3.2%
1/31 • Evaluated for 2 months once drug therapy started.
Toxicities were measured at weekly visit while on therapy using the NCI CTCAE v3.0.
|
|
General disorders
Fatigue
|
3.2%
1/31 • Evaluated for 2 months once drug therapy started.
Toxicities were measured at weekly visit while on therapy using the NCI CTCAE v3.0.
|
|
Infections and infestations
Infection-wound
|
3.2%
1/31 • Evaluated for 2 months once drug therapy started.
Toxicities were measured at weekly visit while on therapy using the NCI CTCAE v3.0.
|
|
Blood and lymphatic system disorders
Decreased Leukocytes (Total WBD)
|
3.2%
1/31 • Evaluated for 2 months once drug therapy started.
Toxicities were measured at weekly visit while on therapy using the NCI CTCAE v3.0.
|
Other adverse events
| Measure |
Pre-surgical Erlotinib Treatment
n=31 participants at risk
Erlotinib 150 mg by mouth daily for 3 weeks followed by cystectomy within 24 hours of the last dose.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
48.4%
15/31 • Evaluated for 2 months once drug therapy started.
Toxicities were measured at weekly visit while on therapy using the NCI CTCAE v3.0.
|
|
Gastrointestinal disorders
Diarrhea
|
19.4%
6/31 • Evaluated for 2 months once drug therapy started.
Toxicities were measured at weekly visit while on therapy using the NCI CTCAE v3.0.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.1%
5/31 • Evaluated for 2 months once drug therapy started.
Toxicities were measured at weekly visit while on therapy using the NCI CTCAE v3.0.
|
|
Blood and lymphatic system disorders
Decreased Neutrophils/Grabulocytes
|
6.5%
2/31 • Evaluated for 2 months once drug therapy started.
Toxicities were measured at weekly visit while on therapy using the NCI CTCAE v3.0.
|
Additional Information
Dr. Arlene O. Siefker-Radtke,Professor, Genitourinary Medical Oncology
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place