A Prospective Phase 2 Study of PEmetrexed in Combination With Cisplatin in Patients With Advanced UrotheLIal CAnceR
Inclusion Criteria:
- Histologic or cytologic diagnosis of urothelial (transitional cell) carcinoma with
the exception of micropapillary subtype
- Patients must have recurrent disease (locally advanced or metastatic) that is not
amenable to local therapy or newly diagnosed distant metastatic disease
- Measurable disease defined by RECIST v.1.0
- ECOG performance status of 2 or better
- Adequate organ and bone marrow function defined as
Exclusion Criteria:
- Other tumor type than urothelial carcinoma
- Presence or history of CNS metastasis
- Prior systemic chemotherapy or immunotherapy (but prior local intravesical
chemotherapy or immunotherapy was allowed. And recurrent disease after adjuvant or
neoadjuvant cisplatin-based systemic chemotherapy is allowed if the last chemotherapy
was administered 1 year or more before the patient enrollment.)
- Presence of second primary malignancy (except in situ carcinoma of the cervix or
adequately treated basal cell carcinoma of the skin)
- Peripheral sensory neuropathy grade 2 or worse
- Other serious illness or medical conditions