Parallel, Randomized, Double-Blind, Placebo Controlled Phase II Adjuvant Studies of Erlotinib and Polyphenon E to Prevent the Recurrence and Progression of Tobacco-Related, Superficial Bladder Cancer

Date de début de l'étude : 1 mai 2004

Inclusion Criteria: * Participants must be former smokers and have ceased smoking at study entry. * Participants with any previous history of prior cancer diagnosis of Grade 1, 2, or 3, Ta or T1 papillary TCC, or CIS TCC, histologically confirmed, with a newly diagnosed or recurrent tumor within 6 months of accrual who are rendered disease free by standard of care. Patients with Grade 1 papillary tumors must meet at least one of the following additional criteria: 1. multiple, synchronous tumors (\>2) 2. a single tumor greater than 1 cm in size * At study entry, patients must have no evidence of disease * Participants may have been previously treated with intravesical therapy. * Age\>18 years * Transurethral resection of bladder tumor within 6 months prior to entry on to study * Participants must have a signed written informed consent * Agreement with complete abstinence from heterosexual intercourse or with the use of contraception during the treatment phase in women of childbearing potential * Negative pregnancy test in women of childbearing potential * Patients must have adequate bone marrow function at study entry (WBC\>3000, platelets\>100000/mm3, and hemoglobin\>10g/dl) * Patients must have satisfactory renal and hepatic function, defined as plasma creatinine of \< 1.5mg/dl, total bilirubin \< 1.5, and AST/ALT \< 1.5 x the upper limit of normal * Patients with evidence of obstructive lung disease as the etiology of a low diffusing capacity will still be eligible as long as the chest radiograph does not demonstrate interstitial changes Exclusion Criteria: * Prior chemotherapy or radiotherapy * Prior (within 2 years) or concurrent malignancies, except non-melanomatous skin tumors or carcinoma in situ of the cervix * Significant medical or psychiatric condition that would make the participant a poor protocol candidate * TCC greater than or equal to T2 at most recent diagnosis * Involvement of the upper urinary tract prior to or at the time of initial tumor resection * Prior treatment with experimental drugs, high dose steroids, or with any other cancer treatment within 4 weeks prior to the first dose of study drug and for the duration of the study * Positive pregnancy test at any time throughout the course of the study * Normal consumption of greater than 5 cups of green tea daily * Participants taking a known CYP 3A4 inducer or food products and medications known to be inhibitors or metabolized by CYP3A4/5 such as erythromycin, ketoconazole, etc. will be excluded since these drugs may be expected to result in altered exposure of Erlotinib * ECOG performance status \> 1 * History of idiopathic pulmonary fibrosis or other interstitial lung disease * Use of tricyclic antidepressants, including imipramine, dothiepin, and mianserin * Use within the last 12 months of amiodarone, methotrexate, isoniazid, minocycline, or nitrofurantoin * History of environmental or occupational metal dust or wood dust exposure * History of connective tissue disease, including scleroderma, rheumatoid arthritis, Sjogren's Syndrome, or sarcoid * Significant ophthalmologic abnormalities or patients using contact lenses * Evidence of interstitial lung disease on chest radiograph * Patients without obvious interstitial lung disease on chest radiograph will be excluded if they have evidence of parenchymal restrictive lung disease on pulmonary function testing as identified by the following criteria: 1. Both vital capacity and total lung capacity \<80% of predicted value 2. A diffusing capacity of the lung for carbon monoxide, corrected for hemoglobin, \< 75% of predicted value