Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC

• Status: Terminated
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial will investigate the activity of sunitinib combined with cisplatin and gemcitabine followed by radical cystectomy in patients with Transitional Cell Carcinoma (TCC) of the Bladder.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Noah Hahn, M.D.
• Collaborators: Hoosier Cancer Research Network; Pfizer
• Treatments: Cisplatin; Gemcitabine; Sunitinib

Criteria

Inclusion Criteria:

• Histological proof of muscle-invasive transitional cell carcinoma of the bladder (stage II-III) with no evidence of metastatic disease (focal squamous and/or adenocarcinoma differentiation allowed, sarcomatoid and small-cell components not allowed). Patient with any degree of fixation of the pelvic sidewall are not eligible.

• Must be willing to undergo a cystoscopy if tumor block is not available prior to registration for protocol therapy.

• Eligible for radical cystectomy as per the attending urologist.

• Prior radiation therapy to bone marrow is allowed to < 25% of the marrow, and must be completed at least 6 months prior to registration for protocol therapy

• Written informed consent and HIPAA authorization for release of personal health information.

• Age > 18 years at the time of consent.

• Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.

• Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.

Exclusion Criteria:

• No prior radiotherapy to the pelvis.

• No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason< grade 7 prostate cancers, or other cancer for which the patient has been disease-free for at least 5 years.

• No treatment with any investigational agent within 30 days prior to registration for protocol therapy.

• No cerebrovascular accident or transient ischemic attack within 6 months prior to registration for protocol therapy.

• No evidence of pulmonary embolism within 6 months prior to registration for protocol therapy.

• No uncontrolled hypertension (>150/100 mm Hg despite optimal medical therapy).

• No evidence of ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade 2.

• No history of uncontrolled/untreated thyroid dysfunction.

• No prolonged QTc interval (> 450 msec) on pre-entry electrocardiogram obtained within 28 days prior to being registered on study.

• Patients on warfarin (>2mg) for thrombosis must be able and willing to switch to low molecular weight heparin prior to registration for protocol therapy.

• No use of drugs having proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide) within 7 days prior to registration for protocol therapy.

• No use of CYP3A4 inhibitors (see section 5.3 for a list) within 7 days of registration for protocol therapy.

• No use of CYP3A4 inducers (see section 5.3 for a list) within 14 days of registration for protocol therapy.

• No use of amiodarone (CYP3A4 inhibitor) within 6 months of registration for protocol therapy.

• Females must not be breastfeeding.