Sorafenib and Radiotherapy in the Treatment of Invasive Bladder Cancer With Conservative Intent (SOGUG-07-01)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Spanish Oncology Genito-Urinary Group.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier:
NCT00544609
First received: October 15, 2007
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Bladder Cancer
Drug: Sorafenib
Procedure: Radiotherapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Sorafenib in Combination With Radiotherapy in the Treatment of Invasive Bladder Cancer With Conservative Intent

Resource links provided by NLM:


Further study details as provided by Spanish Oncology Genito-Urinary Group:

Primary Outcome Measures:
  • Safety profile of Sorafenib in combination with Radiotherapy. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose of Sorafenib in combination with Radiotherapy. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: December 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sorafenib
2 weeks:Sorafenib, 6 weeks and a half:Sorafenib with radiotherapy, 4 weeks:Sorafenib
Drug: Sorafenib
Level 1: 200 mg/day Level 2: 400mg/day Level 3: 800mg/day
Other Names:
  • Sorafenib
  • Nexavar
Procedure: Radiotherapy
3th-8th week: sorafenib daily with radiotherapy day 1, 2, 3, 4 and 5, 9th week: sorafenib daily with radiotherapy day 1 and 2
Other Names:
  • Sorafenib
  • Nexavar

Detailed Description:

Study phase I in patients with Invasive Bladder Cancer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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. 
  • Patient unable to swallow oral medication.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544609

Locations
Spain
Institut Català d' Oncología
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
Sponsors and Collaborators
Spanish Oncology Genito-Urinary Group
Investigators
Study Chair: Xavier García del Muro Solans, MD Institut Català d' Oncología, Barcelona
Study Chair: Salvador Villà Freixa, MD Institut Català d' Oncología, Barcelona
  More Information

No publications provided

Responsible Party: Dr.Bellmunt Molins, Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier: NCT00544609     History of Changes
Other Study ID Numbers: SOGUG-07-01
Study First Received: October 15, 2007
Last Updated: July 19, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Oncology Genito-Urinary Group:
Bladder
Sorafenib
Radiotherapy

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014