Analysis of renal function during angiostatic therapy with the COX-II inhibitor rofecoxib, in combination with pioglitazone, and trofosfamide or capecitabine in patients with metastatic / advanced cancer.
- Conditions
- C80Malignant neoplasm, without specification of site
- Registration Number
- DRKS00000119
- Lead Sponsor
- Abteilung für Hämatologie und Internistische OnkologieKlinikum der Universität Regensburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 87
Patients with either gastrointestinal cancer, including pancreatic, and gall bladder cancer or urological cancer (group A) or metastatic melanoma, sarcoma, pulmonary and gynecological carcinoma or hematological malignancy (group B) were included in the. Additional eligibility criteria included: adequate baseline organ function as evidenced by a serum creatinine concentration at or below 1.8mg/dl, GOT, GPT and GGT below 1.25 times the normal concentration, white blood cell count over 2.0 cells per nL and a platelet count over 100000 cells per µL. Written informed consent had to be obtained before inclusion in the study.
Patients with significant comorbidity including acute infections, inadequately controlled diabetes mellitus, congestive heart failure, angina pectoris and cardiac arrhythmia requiring medical therapy were excluded from the study.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome / Outcome Measures (of the present secondary analysis):Assessment of renal function during and after end of treatment. Serum creatinine concentrations were measured before treatment and monthly during the treatment phase up to 6 months after end of treatment. Glomerular filtration rate was estimated using the method of Cockcroft and Gault.
- Secondary Outcome Measures
Name Time Method