Erlotinib in Treating Patients With Locally Advanced or Metastatic Papillary Renal Cell Cancer

Exclusion Criteria

• •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
• •ANC ≥ 1,500/μl obtained within 14 days prior to registration
• •Platelet count ≥ 100,000/μl obtained within 14 days prior to registration
• •Serum bilirubin ≤ 1.5 x institutional upper limits of normal
• •Serum transaminase (SGOT or SGPT) must be ≤ 1.5 x the institutional upper limit of normal unless the liver is involved with the tumor, in which case serum transaminase (SGOT or SGPT) must be ≤ 5 x the institutional upper limit of normal; these tests must be obtained within 14 days prior to registration
• •Serum creatinine must be ≤ 2 X the institutional upper limit of normal
• •Pregnant or nursing women may not participate on this study because OSI-774 is an epidermal growth factor inhibitor with the potential for teratogenic or abortifacient effects based on the data suggesting that EGFR expression is important for normal organ development; there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OSI-774; women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
• •No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
• •If day 14, 21, 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day; in calculating days of tests and measurements, the day a test or measurement is done is considered to be day 0; therefore, if a test is done on a Monday, the Monday two weeks later would be considered day 14; this allows for efficient patient scheduling without exceeding the guidelines
• •All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
• •At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base