A Phase II Study of OSI-774 (NSC-718781) in Patients With Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer
Overview
- Phase
- Phase 2
- Intervention
- erlotinib hydrochloride
- Conditions
- Recurrent Renal Cell Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Response probability (confirmed complete and partial response)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
This phase II trial is studying how well erlotinib works in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Detailed Description
PRIMARY OBJECTIVES: I. To assess response (confirmed complete and partial response) of patients with locally advanced or metastatic papillary histology renal cell cancer treated with OSI-774. II. To assess the overall survival and 6-month probability of treatment failure of this group of patients. III. To evaluate the qualitative and quantitative toxicities of this regimen. IV. To investigate in a preliminary manner the association of tumor response with tumor expression of epidermal growth factor receptor and status of von Hippel Lindau gene mutation. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have histologically or cytologically confirmed papillary histology renal cell carcinoma which is metastatic (M1); patients with unresectable primary tumor (but M0) are also eligible; patients who have undergone a prior nephrectomy should have histologic confirmation of the metastatic nature of at least one distant site of disease
- •Patients must have available and be willing to submit representative slides for central pathology review; these must be sent within 28 days of registration; failure to submit these materials will make the patient ineligible for this study
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension; soft tissue disease that has been radiated in the 2 months prior to registration is not assessable as measurable disease; soft tissue disease within a prior radiation field that was radiated greater than 2 months prior to registration must have progressed to be considered assessable, and patients also must have measurable disease outside of the irradiated field; X-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; X-rays, scans or physical examinations for non-measurable disease must have been completed within 42 days prior to registration
- •Patients with metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone resection and have recovered from surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery
- •Patients with a history of brain metastases or who currently have treated or untreated brain metastases are not eligible; patients with clinical evidence of brain metastases must have a brain CT or MRI negative for metastatic disease within 56 days prior to registration
- •Patients must have available and be willing to submit archived tumor tissue that will yield sixteen 5 micron unstained slides for molecular correlative studies related to the EGFR and vHL pathways
- •Patients must not have received prior chemotherapy or immunotherapy
- •Patients may have received prior radiation therapy, but must have measurable disease outside the radiation port; at least 21 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration
- •Patients must have a Zubrod performance status of 0 - 2
- •WBC ≥ 3,000/μl obtained within 14 days prior to registration
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (erlotinib hydrochloride)
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: erlotinib hydrochloride
Treatment (erlotinib hydrochloride)
Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Response probability (confirmed complete and partial response)
Time Frame: Up to 3 years
Secondary Outcomes
- Time to treatment failure(6 months)
- Overall survival(6 months)