Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial Cancer
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT00749892
- Phase
- PHASE2
- Status
- Completed
Conditions
- Recurrent Bladder Urothelial Carcinoma
- Recurrent Renal Pelvis Urothelial Carcinoma
- Recurrent Ureter Urothelial Carcinoma
- Recurrent Urethral Urothelial Carcinoma
- Stage 0a Bladder Cancer AJCC v8
- Stage 0a Renal Pelvis Cancer AJCC v8
- Stage 0a Ureter Cancer AJCC v8
- Stage 0a Urethral Cancer AJCC v8
- Stage 0is Bladder Cancer AJCC v8
- Stage 0is Renal Pelvis Cancer AJCC v8
- Stage 0is Ureter Cancer AJCC v8
- Stage 0is Urethral Cancer AJCC v8
- Stage II Bladder Cancer AJCC v8
- Stage II Renal Pelvis Cancer AJCC v8
- Stage II Ureter Cancer AJCC v8
- Stage II Urethral Cancer AJCC v8
- Stage III Renal Pelvis Cancer AJCC v8
- Stage III Ureter Cancer AJCC v8
- Stage III Urethral Cancer AJCC v8
- Stage IIIA Bladder Cancer AJCC v8
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Erlotinib Hydrochloride — DRUGGiven PO
Study Details
This phase II trial studies how well erlotinib hydrochloride works in Treating participants with muscle invasive urothelial cancer or urothelial cancer that has come back. Drugs used in chemotherapy, such as erlotinib hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Key Dates
- First listed
- Sep 9, 2008
- Start date
- Jun 10, 2008
- Status verified
- Aug 2020
- Primary completion
- Jun 30, 2019
- Completion
- Nov 26, 2019
Study Design
- Enrollment
- 34 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (erlotinib hydrochloride)Participants receive erlotinib hydrochloride PO QD for 3-5 weeks in the absence of disease progression or unacceptable toxicity. Within 24 hours of the last dose, participants undergo cystectomy.
Primary Outcome Measure
Response Rate [ Time Frame: Determined at the time of surgery or cystectomy ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | - |
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