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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.

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.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00000119
Enrollment
87
Registered
2009-06-22
Start date
2000-07-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C80

Interventions

Group 1: Therapy with 25mg rofecoxib per day, 45mg pioglitazone per day and 1,0g capecitabine bid per os Group 2: Therapy with 25mg rofecoxib per day, 45mg pioglitazone per day and 50mg trofosfamide p

Sponsors

Abteilung für Hämatologie und Internistische Onkologie Klinikum der Universität Regensburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Germany

Contacts

Public ContactAlbrecht Reichle

Abteilung für Hämatologie und Internistische Onkologie Klinikum der Universität Regensburg

albrecht.reichle@klinik.uni-regensburg.de+49 941 944 5540

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026