Brief Title
Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma
Official Title
A Prospective Phase 2 Study of PEmetrexed in Combination With Cisplatin in Patients With Advanced UrotheLIal CAnceR
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% and 28% for the first-line and second-line setting, respectively. Cisplatin is
one the most active chemotherapeutic agents in urothelial cancer, frequently used as
combination chemotherapy such as GP (gemcitabine plus cisplatin) or MVAC (methotrexate,
vinblastine, adriamycin, and cisplatin).
Pemetrexed and cisplatin showed favorable activity profile in advanced non-small cell lung
cancer with highly favorable toxicity profile.
This study is to assess the efficacy and safety of pemetrexed plus cisplatin in advanced
urothelial carcinoma.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Response rate
Secondary Outcome
Progression-free survival
Condition
Urothelial Carcinoma
Intervention
Pemetrexed
Study Arms / Comparison Groups
PemCis
Description: Pemetrexed plus Cisplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
42
Start Date
July 2008
Completion Date
December 2013
Primary Completion Date
December 2013
Eligibility Criteria
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
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01490437
Organization ID
UOSG-AMC-0804
Responsible Party
Principal Investigator
Study Sponsor
Asan Medical Center
Study Sponsor
, ,
Verification Date
September 2014