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A Phase II Exploratory Study of Pre-Operative Treatment With Erlotinib (Tarceva) in Muscle Invasive or Recurrent Transitional Cell Carcinoma Requiring Cystectomy

Phase 2
18 Years
Open (Enrolling)
Transitional Cell Carcinoma

Thank you

Trial Information

A Phase II Exploratory Study of Pre-Operative Treatment With Erlotinib (Tarceva) in Muscle Invasive or Recurrent Transitional Cell Carcinoma Requiring Cystectomy

The Study Drug:

Erlotinib hydrochloride is designed to block the activity of a protein found on the surface
of many tumor cells that may control tumor growth and survival. This may stop tumors from

Study Drug Administration:

If you are found to be eligible to take part in this study, you will begin taking erlotinib
hydrochloride (a pill) by mouth once a day. You should take it at about the same time each
day, at least 1 hour before or 2 hours after a meal. You should swallow the pill with about
a cup (8 ounces) of water.

It is important that you take the drug every day, as prescribed. If necessary during the
study, the study doctor may decide to lower the dose.

Study Visits:

Once a week during this study, you will have the following tests performed before you take
the study drug:

- Your vital signs will be measured.

- You will be asked about any side effects you may have experienced.

- Blood (about 1 teaspoon) will be drawn for routine tests.

Length of Study Participation:

You may continue receiving the study drug for 3-5 weeks (depending on when your surgery is
scheduled). After that, you will be offered surgery to remove the tumor. You will take
your last study drug dose within 24 hours before having surgery. You will sign a separate
consent form for the surgery, and the procedure and its risks will be described in more
detail at that time.

If the disease gets worse or intolerable side effects occur, you will be taken off study

If you stop taking the study drug early because of intolerable side effects, you will need
to return to the clinic every 2 weeks until surgery. At these visits, your side effects
will be monitored, for example with routine blood tests and/or scans, depending on what the
doctor decides is necessary.

Long-Term Follow-Up:

After surgery, all study participants will return for routine follow-up visits with the

Every 6 months for the first year after surgery and once a year for the next 4 years after
that, the study staff will call you to see how you are doing.

This is an investigational study. Erlotinib hydrochloride is FDA approved and commercially
available for the treatment of non-small cell lung cancer and pancreatic cancer. Its use in
this study is investigational and not FDA approved. For this purpose, at this time it is
being used in research only.

Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Patients must have histologic proof of urothelial cancer. This includes bladder
cancer, in addition to other tumors of the urothelial lining including renal pelvis,
ureteral, and urethral cancer. This group may include any patient requiring
cystectomy, including patients with recurrent or extensive superficial disease
(cTa-T1N0M0), CIS (carcinoma in situ), or muscle invasive disease (cT2-3aN0M0), whose
tumor could not be completely removed at transurethral resection.

2. Patients with the following high-risk features: Micropapillary features (more than
focal on pathology); Small cell carcinoma; 3-D mass on exam under anesthesia (EUA);
Lymphovascular invasion; Hydronephrosis (unless in the opinion of the treating
physician, this is not due to tumor);High grade (grade 3) tumors of the ureter, renal
pelvis, or urethra, or tumors in these areas with radiographic abnormality large
enough to recognize as an abnormal mass by CT or MRI imaging;

3. (# 2 cont'd) Direct invasion of the prostatic stroma or the vaginal wall (ie: cT4a
disease) should be offered neoadjuvant cytoreductive chemotherapy (ie:
cisplatin-based). Patients refusing or who are not considered candidates for
cytoreductive chemotherapy may be considered eligible. Dr. Siefker-Radtke will be the
final arbiter in determining eligibility for the trial.

4. Please note that the presence of variant histologic subtypes is acceptable, except in
the case for small cell variant which is traditionally treated with cytoreductive
chemotherapy. Patients with small cell who refuse recommended cytoreductive
chemotherapy may still be considered eligible.

5. Patients must have an evaluation in the department of urology, and be deemed an
acceptable surgical candidate.

6. Patients must NOT have clinical evidence of metastatic disease by either CT or MRI of
the abdomen and pelvis, and chest x-ray. In the absence of a bone scan, patients
should be free of bone pain and have an alkaline phosphatase < 1.5 x ULN of the upper
limit of normal, or a normal bone fraction of alkaline phosphatase. If these features
are present, patients should have a bone scan and this should be interpreted as
showing no evidence of metastatic disease in order to be eligible.

7. Individuals must be > 18 years of age. In general, urothelial cancer occurs in the
6th to 7th decade of life, so it is unlikely that pediatric patients will be

8. Patients, 18 years and older, must either be not of child bearing potential or have a
negative pregnancy test within 2 weeks of treatment. Patients are considered not of
child bearing potential if they are surgically sterile (they have undergone a
hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are

9. Bone marrow function: absolute neutrophil count (ANC) >/= 1,000/ul; platelets >/=

10. Renal function: creatinine creatinine clearance of > 30 ml/min as calculated by Cockroft-Gault or by 24-hour
urine collection.

11. Hepatic function: bilirubin
12. Zubrod PS
13. Patients with second malignancies are eligible provided that the expected outcome
from the second cancer is such that this will not interfere in the delivery of this
therapy, or in doing cystectomy, and provided that the expectation of survival from
any prior malignancy is reliably > 4 years.

Exclusion Criteria:

1. Acute hepatitis or known HIV.

2. Active or uncontrolled infection.

3. Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled
congestive heart failure, and cardiomyopathy with decreased ejection fraction 40%.

4. Prior therapy specifically and directly targeting the EGFR pathway.

5. Patients with interstitial lung disease.

6. Any concurrent chemotherapy not indicated in the study protocol or any other
investigational agent(s).

7. Patients with metastatic or surgically unresectable disease are not eligible for this
study. In addition, patients who do not agree to surgery are not eligible for this

8. Patients who have received prior systemic chemotherapy or radiation therapy for
urothelial cancer are not eligible. Any prior intravesical chemotherapy is allowed.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate (ie: pT0 rate), defined as the absence of residual cancer in the resected specimen

Outcome Time Frame:

Baseline response to response after 3 weeks of therapy

Safety Issue:


Principal Investigator

Arlene Siefker-Radtke, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2008

Completion Date:

Related Keywords:

  • Transitional Cell Carcinoma
  • Transitional Cell Carcinoma
  • Bladder Cancer
  • Urothelial Cancer
  • Erlotinib Hydrochloride
  • Tarceva
  • OSI-774
  • TCC
  • Carcinoma
  • Carcinoma, Transitional Cell



UT MD Anderson Cancer CenterHouston, Texas  77030