Clinical trial NCT00060307 (phase 2, status: completed)
Conditions: recurrent renal cell cancer, stage iii renal cell cancer, stage iv renal cell cancer
ICD codes: C96.20, C96.29, D47.09, C96.20, C96.29, D47.09, C96.20, C96.29, D47.09
Drugs: erlotinib hydrochloride
SMILES: COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2
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

          -  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

          -  Patients with a known history of the following corneal diseases are not eligible: dry
             eye syndrome, Sjogren's syndrome, keratoconjunctivitis sicca, exposure keratopathy,
             Fuch's dystrophy or other active disorders of cornea

          -  Patients known to be HIV-positive and receiving combination anti-retroviral therapy
             are not eligible due to possible pharmacokinetic interactions with OSI-774

          -  Patients must not have gastrointestinal tract disease resulting in an inability to
             take oral medication or a requirement for IV alimentation, prior surgical procedures
             affecting absorption, or active peptic ulcer disease; patients must either be able to
             swallow and/or receive enteral medications via gastrostomy feeding tube; patients with
             intractable nausea or vomiting are not eligible

          -  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