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A Phase I Pre-cystectomy Trial of Broccoli Extract in Patients With Advanced Bladder Cancer

Phase 1
18 Years
Open (Enrolling)
Recurrent Bladder Cancer, Stage 0 Bladder Cancer, Stage I Bladder Cancer, Stage II Bladder Cancer, Transitional Cell Carcinoma of the Bladder

Thank you

Trial Information

A Phase I Pre-cystectomy Trial of Broccoli Extract in Patients With Advanced Bladder Cancer

Primary Objectives:

I. To determine the tolerability and toxicity of a broccoli sprout extract (providing 200
micro mol isothiocyanate/dose/per day) given for 14 days in patients destined to undergo
definitive bladder resection for bladder cancer.

Secondary Objectives:

I. Establish the safety of administration of the broccoli extract on the bladder surgery

II. Determine the levels of isothiocyanates and their metabolites in urine, blood, benign
urothelium and bladder cancer tissue.

III. Assess the antitumor effects of broccoli extract on the primary bladder tumor by
measuring angiogenesis, cell proliferation and apoptosis.

IV. Determine the feasibility of treating patients with 200 micro mol isothiocyanate per
dose per day of broccoli sprout extract in future therapeutic and prevention clinical

Outline: Patients receive oral broccoli sprout extract once daily on days 1-14 in the
absence of disease progression or unacceptable toxicity. After completion of study
treatment, patients are followed at 4 weeks.

Inclusion Criteria:

- Any patient eligible for cystectomy

- Patients must be considered fit for surgical resection of the bladder with curative

- No chemotherapy, surgery (excluding transurethral resection of bladder tumor [TURBT],
or radiotherapy in the prior 4 weeks [6 weeks for mitomycin C or interferon])

- No previous treatment/ingestion with broccoli extracts

- Eastern Oncology Group (ECOG) performance status 0-2

- AST and ALT =< 2.5 times ULN (upper limit of normal)

- Total bilirubin =< 2.0 mg/dL

- Creatinine Clearance >= 30 ml/min

- WBC > 3000 mm^3

- Absolute neutrophil count > 1000/mm^3

- Platelets > 100,000/mm^3

- All patients must sign a study-specific consent form indicating that they are aware
of the investigational nature of this study

Exclusion Criteria:

- Have participated in any clinical trial involving conventional or investigational
drugs or devices within the previous 4 weeks

- Prior radiation to the pelvis

- Intractable urinary tract infection that has not responded to antibiotic treatment

- Active, uncontrolled bacterial, viral, or fungal infection including HIV

- Have had major surgery within 4 weeks of starting therapy (not including placement of
vascular access device or TURBT)

- Poor medical risk due to non-malignant systemic disease

- Pregnant or lactating patients: patients must be postmenopausal or practicing an
accepted form of birth control; for patients where pregnancy is a possibility, a
pregnancy test will be required prior to initiation of therapy

- Have a history of myocardial infarction or angina pectoris/angina equivalent in the
last 6 months (the patient may be on anti-anginal medications if the symptoms have
been entirely controlled for greater than 6 months), or have uncontrolled congestive
heart failure

- Have a history of bleeding disorders or thrombosis; patients on therapeutic doses of
anticoagulation (including coumadin or heparins) are not permitted on trial (this
exclusion criterion does not include those patients receiving low dose or
prophylactic dose anticoagulation [i.e. coumadin 1 mg daily in patients with central
intravenous lines])

- Radiotherapy during the course of the trial

- Inability to tolerate proposed treatment or procedures

- Have additional uncontrolled serious medical conditions or psychiatric illness

- Patients with a history of hepatitis (including but not exclusive to viral hepatitis
auto-immune or alcoholic)

- Patients with active thyroid disease (patients with hypothyroidism, adequately
replaced on a stable dose of thyroid replacement will be allowed on trial)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity as assessed by National Cancer Institute (NCI) Common Toxicity Criteria version 3.0

Outcome Time Frame:

14 days

Safety Issue:


Principal Investigator

Roberto Pili

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Food and Drug Administration

Study ID:

I 129408



Start Date:

April 2010

Completion Date:

Related Keywords:

  • Recurrent Bladder Cancer
  • Stage 0 Bladder Cancer
  • Stage I Bladder Cancer
  • Stage II Bladder Cancer
  • Transitional Cell Carcinoma of the Bladder
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell



Roswell Park Cancer InstituteBuffalo, New York  14263