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Sponsors and Collaborators: |
Oregon Health and Science University Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00425386 |
RATIONALE: Sunitinib and erlotinib may stop the growth of tumor cell by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib together with erlotinib may kill more tumor cells.
PURPOSE: This phase II trial is studying the best dose of erlotinib when given together with sunitinib and to see how well they work in treating patients with unresectable or metastatic kidney cancer.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Drug: erlotinib hydrochloride Drug: sunitinib malate Procedure: biopsy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Dose Escalation Phase II Study of Sunitinib Plus Erlotinib in Advanced Renal Carcinoma |
Estimated Enrollment: | 49 |
Study Start Date: | November 2006 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter, dose-escalation study of erlotinib hydrochloride.
Patients receive oral sunitinib malate once daily on days 1-28 and oral erlotinib hydrochloride once daily on days 1-42. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 33% of patients experience dose-limiting toxicity. Once the MTD is determined, patients are treated with erlotinib hydrochloride at the MTD and sunitinib malate.
Patients undergo blood and tumor specimen collection periodically during study for future correlative studies.
PROJECTED ACCRUAL: A total of 49 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed renal cell carcinoma with a component of clear cell or papillary carcinoma
PATIENT CHARACTERISTICS:
None of the following cardiovascular conditions within the past 12 months:
PRIOR CONCURRENT THERAPY:
No concurrent therapeutic warfarin
United States, Oregon | |
Oregon Health and Science University Cancer Institute | Recruiting |
Portland, Oregon, United States, 97239-3098 | |
Contact: Clinical Trials Office - Oregon Health and Science University 503-494-1080 trials@ohsu.edu | |
Providence Cancer Center at Providence Portland Medical Center | Recruiting |
Portland, Oregon, United States, 97213-2967 | |
Contact: Clinical Trials Office - Providence Cancer Center at Providenc 503-215-6412 |
Study Chair: | Christopher W. Ryan, MD | Oregon Health and Science University Cancer Institute |
Study ID Numbers: | CDR0000526204, OHSU-2683, OHSU-SOL-06051-LM |
Study First Received: | January 19, 2007 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00425386 |
Health Authority: | Unspecified |
stage III renal cell cancer stage IV renal cell cancer clear cell renal cell carcinoma recurrent renal cell cancer |
Erlotinib Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Urologic Diseases |
Sunitinib Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Clear cell renal cell carcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |