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Phase II Trial of Neoadjuvant Dose Dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer

Phase 2
18 Years
Open (Enrolling)
Urothelial Carcinoma

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Trial Information

Phase II Trial of Neoadjuvant Dose Dense Gemcitabine and Cisplatin In Muscle Invasive Bladder Cancer

This is a single arm Phase II study utilizing neoadjuvant DD GC in patients with muscle
invasive urothelial carcinoma of the bladder who will be undergoing cystectomy with goal of
cure. Initial transurethral biopsy tissue may be obtained at an outside institution, but
must be confirmed by pathologic review at a study site. Patients will undergo radiographic
staging prior to initiation of chemotherapy, after completion of chemotherapy and surgery,
and will continue on surveillance follow-up as guided by the NCCN guidelines following
surgery for a total of 5 years from study entry or until death. Treatment with three cycles
of DD GC will be administered on an inpatient or outpatient basis.

Inclusion Criteria:

- Patients must have histologically confirmed urothelial carcinoma of the bladder or
urethra. Patients with urothelial carcinoma of the prostatic urethra only may be
included at PI discretion. T-stage must be T2 to T4a. Patients with clinical N0
disease or cN1 disease are eligible for the study. Patients should have no
radiographic evidence of metastatic disease. Mixed histologies which are
predominantly urothelial, such as with squamous or micropapillary differentiation,
are allowed so long as there is no component of small cell histology. Histology must
be confirmed by a pathologist at an institution involved in this study.

- Patients must be candidates for radical cystectomy with the goal of cure.

- Age >18 years.

- ECOG performance status of 0 or 1

- Patients must have normal hepatic and marrow function as defined below:

leukocytes ≥ 3,000/mcL absolute neutrophil count ≥ 1,500/mcL platelets ≥ 100,000/mcL total
bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤ 2.5 X
institutional ULN

- Patients must have adequate renal function defined as Creatinine Clearance ≥ 50
mL/min. For eligibility, creatinine clearance may be either calculated using the
Cockroft-Gault formula or measured with 24 hour urine collection. Note that 24 hour
urine collection is required at baseline, but does not have to be used for
eligibility if calculated clearance by Cockroft-Gault is preferred. Neprostomy or
ureteral stent placement in order to achieve adequate creatinine clearance is

- The effects of DD-GC on the developing human fetus at the recommended therapeutic
dose are unknown. For this reason and because the chemotherapeutic agents used in
this trial are known to be teratogenic, women of child-bearing potential (WOCBP) and
men with female partner who are WOCBP must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) starting at or before the
pre-study pregnancy test and continuing until at least 3 months after last study both
chemotherapy and surgery. Should a woman become pregnant or suspect she is pregnant
while participating in this study, she should inform her treating physician
immediately. WOCBP must have a negative serum or urine pregnancy test within 7 days
prior to study entry.

- No other active malignancy.

- Ability to understand and the willingness to sign written informed consent and HIPAA

Exclusion Criteria:

- Patients who have had intravesicular therapy within 4 weeks of study entry, or those
who have not recovered from adverse effects of such agents administered more than 4
weeks earlier.

- Patients may not be receiving any investigational agents within 4 weeks of study

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Gemcitabine or Cisplatin or other agents used in the study.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Pregnant women are excluded from this study due to the potential for teratogenic or
abortifacient effects of cytotoxic chemotherapy.

- Known HIV-positive patients on combination antiretroviral therapy are ineligible
because of the potential for pharmacokinetic interactions with cytotoxic
chemotherapy. In addition, these patients are at increased risk of lethal infections
when treated with marrow-suppressive therapy.

- Patients who have undergone prior radiation to greater than or equal to 25% of the
bone marrow within the past year are excluded due to risk of life threatening

- Patients who have received any previous systemic chemotherapy or radiation therapy
for urothelial carcinoma within 1 year of study entry are ineligible.

Type of Study:


Study Design:

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

Outcome Measure:

Rate of complete response at cystectomy

Outcome Description:

To assess the rate of complete response (pT0) at cystectomy following preoperative dose dense gemcitabine and cisplatin (DD GC) in patients with muscle invasive urothelial carcinoma of the bladder.

Outcome Time Frame:

Up to 60 months

Safety Issue:


Principal Investigator

Elizabeth Plimack, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2012

Completion Date:

May 2014

Related Keywords:

  • Urothelial Carcinoma
  • urothelial carcinoma of the bladder or urethra
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell



Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541