Sorafenib and Radiotherapy in the Treatment of Invasive Bladder Cancer With Conservative Intent

NCT00544609 | Completed Phase 1 DMC

• 1 other identifier: SOGUG-07-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

Safety profile and to determine maximum tolerated dose of Sorafenib in combination with Radiotherapy in the Treatment of Invasive Bladder Cancer With Conservative Intent

Conditions

Bladder Cancer

Keywords

Bladder; Sorafenib; Radiotherapy

Outcome Measures

Primary Outcomes (2)

• Safety profile of Sorafenib in combination with Radiotherapy.

  12 weeks

• Maximum tolerated dose of Sorafenib in combination with Radiotherapy.

  12 weeks

Study Arms (1)

Sorafenib

OTHER

2 weeks:Sorafenib, 6 weeks and a half:Sorafenib with radiotherapy, 4 weeks:Sorafenib

Drug: Sorafenib; Procedure: Radiotherapy

Interventions

Sorafenib DRUG

Level 1: 200 mg/day Level 2: 400mg/day Level 3: 800mg/day

Also known as: Nexavar

Sorafenib

Radiotherapy PROCEDURE

3th-8th week: sorafenib daily with radiotherapy day 1, 2, 3, 4 and 5, 9th week: sorafenib daily with radiotherapy day 1 and 2

Also known as: Sorafenib, Nexavar

Sorafenib

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with urothelial carcinoma of the bladder, in clinical stages T2-4a N0 M0 (if multifocal evaluation of all lesions by biopsies), who are not candidates for radical cystectomy by medical reasons or refusal.
• No prior treatment with radiotherapy to the bladder or systemic chemotherapy.
• Patients must be ≥ 18 years old.
• Patients must have ECOG performance status 0 to 2.
• Life expectancy of at least 12 weeks.
• Patients with adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
• hemoglobin ≥ 9.0 g/dl absolute neutrophil count ≥ 1.500/mm3 platelets ≥ 100.000/mm3. total bilirubin ≤ 1.5 times the upper limit of normality SGOT (AST) and/or SGPT (ALT) ≤ 2.5 times the upper limit of normality alkaline phosphatase ≤ 4 x ULN serum creatinine ≤1.5 upper limit of normality PT-INR/PTT \< 1.5 x upper limit of normality creatinine clearance ≥ 40 ml/min using Cockcroft-Gaul
• Patients must give their written informed consent before any procedure related to the study is performed; therefore, it must be given at the selection visit. The patient must be informed that he has the right to withdraw from the study at any time, without any kind of prejudice.
• Patients who are capable of accomplishing the study's requirements and without any impediments to follow the instructions.
• Women of fertile age must have a negative result in the pregnancy test performed 7 days before the beginning of the administration of the study medication.
• Patients from both sexes must use adequate contraceptive methods (oral or injectable contraceptives, intrauterine device, condom, sterilization) whilst participating in the protocol. After the retreat of treatment with sorafenib, the contraceptive methods must be used during 4 weeks in women and during 3 months in men.

You may not qualify if:

• Patients with active infection or other serious medical conditions (autologous bone marrow transplant or stem cell rescue within 4 months of study, patients undergoing renal dialysis, known HIV infection or chronic hepatitis B or C, active clinically serious infections \> CTCAE Grade 2, non-healing wound, ulcer, or bone fracture).
• Abuse of substances, clinical conditions, psychological or social, that would preclude appropriate informed consent or compliance with protocol.
• Concurrent treatment with other experimental drugs (within 30 days prior to study entry).
• Concurrent treatment with other anti-cancer- or immunotherapy during the study or within 4 weeks of study entry.
• Treatment wuth mitomycin C or nitrosureas during 6 weeks prior of study entry.
• History of prior malignancies within the preceding 5 years other than previously treated basal cell carcinoma of the skin, incipient prostate cancer and in situ cervix carcinoma.
• Pregnant or breast feeding patients.
• Known or suspected allergy to sorafenib.
• Cardiac disease: Congestive heart failure \> class II NYHA; active CAD (myocardial infarction more than 6 months to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted).
• Uncontrolled hypertension defined as systolic blood pressure \> 150 mm Hg or diastolic pressure \> 90 mm Hg, despite optimal medical management.
• Known brain metastasis. Patients with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis.
• Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months.
• Patients with hydronephrosis.
• Patients with seizure disorder requiring medication (such as steroids or antiepileptics).
• History of organ allograft.

Sponsors & Collaborators

• Spanish Oncology Genito-Urinary Group: lead

Study Sites (3)

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Institut Català d' Oncología

Barcelona, Spain

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Sorafenib; Radiotherapy

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)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Therapeutics

Study Officials

• Xavier García del Muro Solans, MD

  Institut Català d' Oncología, Barcelona

  STUDY CHAIR

• Salvador Villà Freixa, MD

  Institut Català d' Oncología, Barcelona

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 16, 2007
• Study Start: December 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: May 1, 2012
• Last Updated: October 2, 2014

Record last verified: 2014-10

Locations

ES (3)