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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
| Information provided by: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00060307 |
Purpose
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: erlotinib hydrochloride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of OSI-774 (NSC-718781) in Patients With Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer |
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2003 |
OBJECTIVES:
OUTLINE: Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-20 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed papillary renal cell cancer, meeting 1 of the following stage criteria:
Prior resection of primary tumor allowed
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Ophthalmic
No known history of any of the following corneal diseases:
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations
Show 181 Study Locations| Study Chair: | Michael S. Gordon, MD | Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea |
| Study Chair: | Janice P. Dutcher, MD | Our Lady of Mercy Medical Center Comprehensive Cancer Center |
More Information
| Responsible Party: | Laurence H. Baker, D.O., Chairman, SWOG |
| ClinicalTrials.gov Identifier: | NCT00060307 History of Changes |
| Other Study ID Numbers: | CDR0000301594, SWOG-S0317, ECOG-S0317 |
| Study First Received: | May 6, 2003 |
| Last Updated: | July 21, 2011 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
|
recurrent renal cell cancer stage IV renal cell cancer stage III renal cell cancer |
|
Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Kidney Diseases Urologic Diseases Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |