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Clinical Trials/DRKS00000119
DRKS00000119
Completed
Phase 2

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.

Abteilung für Hämatologie und Internistische OnkologieKlinikum der Universität Regensburg0 sites87 target enrollmentJune 22, 2009

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
C80
Sponsor
Abteilung für Hämatologie und Internistische OnkologieKlinikum der Universität Regensburg
Enrollment
87
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 22, 2009
End Date
October 4, 2005
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Abteilung für Hämatologie und Internistische OnkologieKlinikum der Universität Regensburg

Eligibility 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

  • 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.

Outcomes

Primary Outcomes

Not specified

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