Status:
COMPLETED
Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma
Lead Sponsor:
Asan Medical Center
Conditions:
Urothelial Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Pemetrexed has demonstrated a favorable response with minimal toxicity when used as single agent as first-line and second-line treatment for advanced urothelial carcinoma. The response rates were 32% ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01490437
Start Date
July 1 2008
End Date
December 1 2013
Last Update
September 25 2014
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736