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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00623064 |
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with combination chemotherapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when given together with cisplatin and gemcitabine as first-line therapy in treating patients with locally advanced or metastatic urothelial cancer.
Condition | Intervention | Phase |
---|---|---|
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter |
Drug: cisplatin Drug: gemcitabine hydrochloride Drug: lapatinib ditosylate Procedure: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I Study of Cisplatin, Gemcitabine and Lapatinib as First Line Treatment in Advanced/Metastatic Urothelial Cancer |
Estimated Enrollment: | 25 |
Study Start Date: | November 2007 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study of lapatinib ditosylate.
All patients undergo blood sample collection periodically for pharmacokinetic analysis.
After completion of study treatment, patients are followed weekly.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven transitional cell carcinoma of the urothelial tract
Measurable disease according to RECIST
PATIENT CHARACTERISTICS:
No serious cardiac illness or medical condition within the past 6 months including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Prior neoadjuvant or adjuvant chemotherapy allowed
Denmark | |
Rigshospitalet - Copenhagen University Hospital | Recruiting |
Copenhagen, Denmark, 2100 | |
Contact: Contact Person 45-3545-3545 |
Study Chair: | Gedske Daugaard, MD, DMSc | Rigshospitalet, Denmark |
Study ID Numbers: | CDR0000581013, EORTC-30061, EUDRACT-2006-002976-16, GSK-EORTC-30061 |
Study First Received: | February 22, 2008 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00623064 |
Health Authority: | Unspecified |
transitional cell carcinoma of the bladder stage IV bladder cancer stage III bladder cancer metastatic transitional cell cancer of the renal pelvis and ureter regional transitional cell cancer of the renal pelvis and ureter |
Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Ureteral Diseases Lapatinib Urogenital Neoplasms Renal cancer Kidney cancer Carcinoma, Transitional Cell Urologic Neoplasms Transitional cell carcinoma |
Carcinoma Cisplatin Urologic Diseases Kidney Neoplasms Kidney Diseases Gemcitabine Ureteral Neoplasms Urinary tract neoplasm Bladder neoplasm Neoplasms, Glandular and Epithelial |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Protein Kinase Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |