Clinical trial · Interventional
Neoadjuvant Cisplatin, Gemcitabine, Sunitinib Malate + Radical Cystectomy for TCC
A Phase II Trial of Neoadjuvant Cisplatin, Gemcitabine and Sunitinib Malate Followed by Radical Cystectomy for Transitional Cell Carcinoma (TCC) of the Bladder: Hoosier Oncology Group GU07-123
NCT00859339CI-TRIAL-00021756terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Patient Toxicities
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Transitional Cell Carcinoma of the Bladder | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Radical Cystectomy | Procedure | — | UNRESOLVED |
| Sunitinib Malate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Treatment
- description
- Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
- interventionNames
- Drug: Gemcitabine
- Drug: Cisplatin
- Drug: Sunitinib Malate
- Procedure: Radical Cystectomy
Primary outcomes (1)
- measure
- Pathological Complete Response (pCR) Rate.
- timeFrame
- 18 months
- description
- number of participants with a pCR
Secondary outcomes (4)
- measure
- Safety Profile
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGalsky MD, Hahn NM, Powles T, Hellerstedt BA, Lerner SP, Gardner TA, Yu M, O'Rourke M, Vogelzang NJ, Kocs D, McKenney SA, Melnyk AM Jr, Hutson TE, Rauch M, Wang Y, Asmar L, Sonpavde G. Gemcitabine, Cisplatin, and sunitinib for metastatic urothelial carcinoma and as preoperative therapy for muscle-invasive bladder cancer. Clin Genitourin Cancer. 2013 Jun;11(2):175-81. doi: 10.1016/j.clgc.2012.10.001. Epub 2012 Dec 8. PMID 23228446