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

NCT00859339 | Terminated Phase 2 Results DMC

• 1 other identifier: HOG GU07-123
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

Transitional Cell Carcinoma of the Bladder

Keywords

TCC

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR) Rate.

  number of participants with a pCR

  18 months

Secondary Outcomes (4)

• Safety Profile

  18 months

• Objective Response Rate

  18 months

• Progression Free Survival

  18 months

• Correlate Biomarker Expression

  18 months

Study Arms (1)

Experimental Treatment

EXPERIMENTAL

Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy

Drug: Gemcitabine; Drug: Cisplatin; Drug: Sunitinib Malate; Procedure: Radical Cystectomy

Interventions

Gemcitabine DRUG

Gemcitabine ( 1000 mg/m2) IV days 1 and 8

Experimental Treatment

Cisplatin DRUG

Cisplatin (70 mg/m2) IV day 1

Experimental Treatment

Sunitinib Malate DRUG

Sunitinib malate (37.5 mg) oral daily for days 1-14

Experimental Treatment

Radical Cystectomy PROCEDURE

Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.

Experimental Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Noah Hahn, M.D.: lead
• Pfizer: collaborator
• Hoosier Cancer Research Network: collaborator

Study Sites (5)

University of Florida

Gainesville, Florida, 32610, United States

Location

Indiana University Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Northern Indiana Cancer Research Consortium

South Bend, Indiana, 46601, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

St. Bartholomew's Hospital (Barts)

London, EC1A 7BE, United Kingdom

Location

Related Publications (1)

• Galsky 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 DERIVED

Related Links

• Hoosier Oncology Group Homepage

MeSH Terms

Interventions

Gemcitabine; Cisplatin; Sunitinib; Cystectomy

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Pyrroles; Azoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Limitations and Caveats

Study was terminated due to pre-defined stopping rules (patient toxicities)

Results Point of Contact

• Title: Clinical Data Coordinator
• Organization: Hoosier Cancer Research Network, Inc.

jsmith@hoosiercancer.org

317-921-2050

Study Officials

• Noah Hahn, M.D.

  Hoosier Cancer Research Network

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 11, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 14, 2016
• Results First Posted: April 14, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); GB (1)