Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma

Urothelial Carcinoma Clinical Trial

— PECULIAR  

Official title:

A Prospective Phase 2 Study of PEmetrexed in Combination With Cisplatin in Patients With Advanced UrotheLIal CAnceR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490437
• Other study ID #: UOSG-AMC-0804
• Status: Completed
• Phase: Phase 2
• First received: December 6, 2011
• Last updated: September 22, 2014
• Start date: July 2008
• Est. completion date: December 2013

Study information

• Verified date: September 2014
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Drug:
• Pemetrexed
Pemetrexed 500 mg/m2 IV over 10 minutes on D1 every 3 weeks
• Cisplatin
Cisplatin 70 mg/m2 IV over 60 minutes on D1 every 21 days
• Dexamethasone
Dexamethasone 4 mg bid PO from D-1 to D2 every 3 weeks
• Vitamins
Folic acid 350 ug - 600 ug daily from D-7 daily vitamin B12 1,000 ug every 9 weeks from D-7

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Based on RECIST v.1.0	12 months	No
Secondary	Progression-free survival		12 months	No
Secondary	Overall survival		12 months	No
Secondary	Safety	Based on NCI CTCAE v.3.0	8 months	Yes