MDACC Study Summary SWOGS0337

Study Summary
No. SWOGS0337:.......Bladder......Ashish M. Kamat......Urology

Study Summary Title



Study Summary Number:	SWOGS0337

Study Title:	A Phase III Blinded Study of Immediate Post-TURBT Instillation of Gemcitabine Versus Saline in Patients with Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer

Physician

New Patient Referral



Name:	Ashish M. Kamat	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Urology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-7475 Contact us about clinical trials

General Information



Disease Group:	Bladder	Supported By:	Southwest Oncolgy Group (SWOG)

Phase of Study:	Phase III	Return Visit:	Patient will be follow for up to 4 years from the start of the study and will need to come for routine follow-up evaluations (cystoscopy and urinary cytology) every 3 months the first and second year and every 6 months for the next two years.

Treatment Agents:	Gemcitabine	Home Care:	None

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	23 hours or less


Description/ Intervention:	The goal of this clinical research study is to learn if gemcitabine (when given directly into your bladder within 3 hours after the tumor is removed from the bladder) can help to prevent bladder tumors from returning. The safety of this drug will also be studied.

Study Objectives / Outcomes

The primary objective of this study is to determine the efficacy of a single post transurethral resection of the bladder (TURBT) intravesical instillation of gemcitabine versus saline in preventing recurrence of completely resected Grade 1 or 2, Ta or T1 transitional cell cancer (TCC) of the bladder at two years.

Secondary objectives of this study include the following:

a. To test whether a single instillation of intravesical gemcitabine can improve the time to progression to muscle invasive disease compared to saline in this patient population.

b. To compare the qualitative and quantitative toxicities between the arms.

c. To determine if effective post TURBT instillation therapy results in reduced long term morbidity as determined by patients randomized to gemcitabine requiring fewer TURBTs, courses of traditional intravesical therapies, and surveillance cystoscopies over four years compared with those randomized to intravesical saline.

d. The correlative studies will evaluate whether performing a combination of molecular/cytologic diagnostic marker tests including NMP-22 Bladder Check and BTA Stat every three months can predict recurrence as accurately as cystoscopy alone.

e. To acquire blood and tissue specimens from patients on this clinical trial for banking for genotyping.

Study Status Information



Study Activation / Registration Date:	01/16/2009

IRB Review and Approval Date:	01/16/2009

Study Type:	Phase Iii

Recruitment Status:	Open

Projected Accrual:	340

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) The patient clinically appears to have newly diagnosed or recurrent Grade 1 or 2, Ta or T1 urothelial (transitional cell) cancer of the bladder.

2) There must be plans for the patient to receive a TURBT within 28 working days after randomization. There must be plans for treatment to be given within three hours of TURBT.

3) have had no more than 2 recurrences (other than the index tumor) in the 18 months preceding the index tumor's TURBT which are also Grade 1 or 2, Stage Ta or T1 without any previous TIS or Grade 3 cancers within 2 years preceding the index tumor TURBT or any history of muscularis propria invading (Stage >/= T2),

4) In their urologist's opinion not currently be a candidate for treatment other than a TURBT (e.g., a series of BCG instillations).

5) Patients should be believed based upon endoscopic inspection not to have urothelial cancer of the prostate or more distal urethra (or urethra at all in women). Endoscopy must be performed within 56 days prior to registration.

6) Patients should have negative upper tract imaging studies obtained within 365 days prior to registration. Imaging studies may be performed after registration, but prior to TURBT on the day of treatment.

7) Patients must have a negative urine culture (including </= 10,000 col/ml or "mixed floralikely contamination") OR a negative urine analysis for infection with (either a microscopic urinalysis with negative nitrates and no organisms on reagent strip and < 10 WBC/HPF OR an automated or visual reagent strip urinalysis which is negative for leukocytes and nitrates) within 28 days prior to registration.

8) Patients must have a Zubrod performance status of 0 - 1.

9) Patients must be offered the opportunity to participate in specimen banking.

10) All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

11) Patients must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method.

Exclusion Criteria:

1) Except as outlined above, no other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 3 years.

2) Patients must not have received previous intravesical therapy within 145 days prior to registration. Patients must not be considered by their treating physician to be candidates for more intensive treatments such as a series of instillations of intravesical immunotherapy (e.g. BCG) or intravesical chemotherapy, or for cystectomy or partial cystectomy.

Links

Registration Number: NCT00445601
Study Information on Clinical Trials Registry (clinicaltrials.gov)