A comparative study between two different chemotherapy treatments for patients with metastatic bladder cancer and renal impairment
- Conditions
- ocally advanced or Metastatic urothelial carcinomaMedDRA version: 18.1Level: LLTClassification code 10046721Term: Urothelial carcinoma bladder stage IIISystem Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10046723Term: Urothelial carcinoma ureterSystem Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10046714Term: Urothelial carcinoma bladderSystem Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10046722Term: Urothelial carcinoma bladder stage IVSystem Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10046725Term: Urothelial carcinoma ureter metastaticSystem Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10046730Term: Urothelial carcinoma urethra metastaticSystem Organ Class: 100000004864MedDRA version: 18.1Level: LLTClassification code 10046728Term: Urothelial carcinoma urethraSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-002417-35-FI
- Lead Sponsor
- Department of Oncology, Karolinska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 62
Signed informed consent.
Histological or cytological confirmed transitional cell carcinoma of the urothelial tract (mixed histology including transitional cell carcinoma are allowed).
Unresectable (T4b), locally advanced (lymph node positive (N+)) or metastatic (M1) urothelial carcinoma (including renal pelvic tumours, urethral tumours, urinary bladder tumours and urethral primary tumours).
No prior chemotherapy or other anti-cancer drugs. Patients who have received neoadjuvant or adjuvant platinum containing chemotherapy and who are diagnosed with loco regional recurrent or metastatic disease after 6 months are eligible.
Impaired renal function, creatinine clearance 30 – 60 ml/min (measured by Iohexol or Cr-EDTA technique)
ECOG/WHO Performance Status (PS) 0-1.
= 4 weeks since prior surgery, = 2 weeks since prior radiation therapy.
Measurable and/or non-measurable disease using the RECIST criteria defined as:
-Measurable disease: lesions that can be measured in at least one dimension and which have not been previously irradiated. Longest diameter = 20 mm with conventional techniques or = 10 mm with spiral CT scan or MRI.
-Non-measurable disease: lesions which have not been previously irradiated, longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan or MRI, or truly non measurable lesions including bone lesions, ascites, pleural/pericardial effusion, and lymphangitis cutis/pulmonitis.
CNS metastases and/or leptomeningeal metastases are allowed provided these have been adequately treated with radiotherapy, are stable and not generation any symptoms.
Spinal cord compression due to metastatic lesions is allowed provided adequate surgery and/or radiotherapy has been delivered, the metastases are stable and not generating any symptoms.
No known or suspected allergy to the investigational agents or any agents given in association with this trial.
18 years of age or older.
Fertile men and women of childbearing potential must use secure contraception from before entering the study until 6 months after end of chemotherapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Not fulfilling inclusion criteria as described above
Pure non-transitional cell carcinoma of the urothelial.
Impaired bone marrow function defined as WBC < 3.0 x 109/L, neutrophils < 1.5 x 109/L, platelets < 125 x 109/L, haemoglobin < 100 g/L.
Impaired liver function defined as serum bilirubin > 1.5 x upper limit of normal (ULN) and/or ASAT/ALAT > 2.5 x ULN (> 5 x ULN if known liver metastasis).
Electrocardiogram (ECG) with significant modifications suggesting a high risk of occurrence of angina pectoris or high risk arrhythmia.
Other malignancies, except adequately treated basal carcinoma or squamos cell carcinoma of the skin or in-situ cervix carcinoma or incidental prostate cancer (T1a, Gleason score = 6, PSA < 0.5 ng/ml), or any other tumour with a disease free survival of = 5 years.
History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to:
-Active infection requiring antibiotics within 2 weeks before the study inclusion,
-Unstable diabetes mellitus,
-Hypercalcaemia >2.9 mmol/L or grade ? 2 according to CTCAE v 4.0,
-Concurrent congestive heart failure NYHA (class III-IV),
-Unstable angina pectoris, or myocardial infarction within 6 months and/or poorly controlled hypertension,
-Inflammatory bowel disease,
-Peripheral neuropathy grade = 2 according to CTCAE v 4.0,
Patients who require treatment with ketoconazole, itraconazole, ritonavir, amprenavir, indinavir, rifampicine (any potent CYP3A4 inhibitor or inducer) or phenytoine.
Pregnant or lactating women.
Any psychological, familial, sociological, or geographical condition which does not permit protocol compliance and medical follow-up.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method