Cisplatin, Gemcitabine Hydrochloride, and Sorafenib Tosylate in Treating Patients With Transitional Cell Cancer of the Bladder

NCT01222676 | Unknown Phase 2

• 4 other identifiers: ITA-MIL-IRCCS-INT-52/10CDR0000686602EUDRACT-2010-022653-41EU-21077
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Giving cisplatin and gemcitabine hydrochloride together with sorafenib tosylate may kill more tumor cells. Giving them before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving cisplatin and gemcitabine hydrochloride together with sorafenib tosylate works in treating patients with node-negative transitional cell cancer of the bladder.

Conditions

Bladder Cancer

Keywords

transitional cell carcinoma of the bladder; stage II bladder cancer; stage III bladder cancer; stage IV bladder cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response

Secondary Outcomes (3)

• Safety and tolerability

• Potential biological correlates of disease response and drug activity in tumor tissue samples before and after therapy

• Correlation between 18FDG-PET and standard CT results

Interventions

cisplatin DRUG

gemcitabine hydrochloride DRUG

sorafenib tosylate DRUG

imaging biomarker analysis OTHER

laboratory biomarker analysis OTHER

computed tomography PROCEDURE

neoadjuvant therapy PROCEDURE

fludeoxyglucose F 18 RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Confirmed transitional cell carcinoma (TCC) of the bladder at the time of diagnostic transurethral resection of the bladder tumor (TURB)\* * Muscle-invasive (T ≥ 2) disease at TURB OR clinical stage T3 or T4 disease (e.g., T2 patients will not be eligible without a histological documentation of invasive disease) * NOTE: \*Confirmation of TCC histology based on pathologic review at Fondazione Istituto Nazionale dei Tumori Milan will be required in all cases. * Clinically node-negative (cN0) disease PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * WBC ≥ 2,000/µL * ANC ≥ 1,500/µL * Platelet count ≥ 100,000/µL * Serum creatinine ≤ 1.5 mg/dL * AST/ALT \< 2.5 times upper limit of normal (ULN) (\< 5 times ULN if due to hepatic metastases) * Total bilirubin \< 1.5 times ULN * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * Negative serology for the following infectious diseases: * HIV type 1 or 2 * Hepatitis B surface antigen (active carriers) * Hepatitis C PRIOR CONCURRENT THERAPY: * No prior systemic therapies except for intravesical therapy for superficial disease * No prior sorafenib tosylate * No prior systemic chemotherapy * At least 4 weeks since prior investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione Istituto Nazionale dei Tumori

Milan, 20133, Italy

RECRUITING

Related Publications (1)

• Necchi A, Lo Vullo S, Raggi D, Perrone F, Giannatempo P, Calareso G, Togliardi E, Nicolai N, Piva L, Biasoni D, Catanzaro M, Torelli T, Stagni S, Colecchia M, Busico A, Pennati M, Zaffaroni N, Mariani L, Salvioni R. Neoadjuvant sorafenib, gemcitabine, and cisplatin administration preceding cystectomy in patients with muscle-invasive urothelial bladder carcinoma: An open-label, single-arm, single-center, phase 2 study. Urol Oncol. 2018 Jan;36(1):8.e1-8.e8. doi: 10.1016/j.urolonc.2017.08.020. Epub 2017 Sep 12.

  PMID: 28911922 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cisplatin; Gemcitabine; Sorafenib; Neoadjuvant Therapy; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Combined Modality Therapy; Therapeutics; Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Roberto Salvioni, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 18, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2013
• Last Updated: August 12, 2013

Record last verified: 2010-10

Locations

IT (1)