Back to resultsPemetrexed and Cisplatin in Advanced Urothelial Carcinoma (PECULIAR)
Primary Purpose
Urothelial Carcinoma
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pemetrexed
Cisplatin
Dexamethasone
Vitamins
Sponsored by
About this trial
This is an interventional treatment trial for Urothelial Carcinoma focused on measuring Advanced urothelial carcinoma
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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PemCis
Arm Description
Pemetrexed plus Cisplatin
Outcomes
Primary Outcome Measures
Response rate
Based on RECIST v.1.0
Secondary Outcome Measures
Progression-free survival
Overall survival
Safety
Based on NCI CTCAE v.3.0
Full Information
NCT ID
NCT01490437
First Posted
December 6, 2011
Last Updated
September 22, 2014
Sponsor
Asan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01490437
Brief Title
Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma
Acronym
PECULIAR
Official Title
A Prospective Phase 2 Study of PEmetrexed in Combination With Cisplatin in Patients With Advanced UrotheLIal CAnceR
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma
Keywords
Advanced urothelial carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PemCis
Arm Type
Experimental
Arm Description
Pemetrexed plus Cisplatin
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Other Intervention Name(s)
Alimta
Intervention Description
Pemetrexed 500 mg/m2 IV over 10 minutes on D1 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
cisplan
Intervention Description
Cisplatin 70 mg/m2 IV over 60 minutes on D1 every 21 days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Dexa
Intervention Description
Dexamethasone 4 mg bid PO from D-1 to D2 every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Vitamins
Intervention Description
Folic acid 350 ug - 600 ug daily from D-7 daily vitamin B12 1,000 ug every 9 weeks from D-7
Primary Outcome Measure Information:
Title
Response rate
Description
Based on RECIST v.1.0
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
12 months
Title
Overall survival
Time Frame
12 months
Title
Safety
Description
Based on NCI CTCAE v.3.0
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
25429526
Citation
Choi YJ, Lee SH, Lee JL, Ahn JH, Lee KH, You D, Hong B, Hong JH, Ahn H. Phase II study of pemetrexed in combination with cisplatin in patients with advanced urothelial cancer: the PECULIAR study (KCSG 10-17). Br J Cancer. 2015 Jan 20;112(2):260-5. doi: 10.1038/bjc.2014.591. Epub 2014 Nov 27.
Results Reference
derived
Learn more about this trial
Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma
We'll reach out to this number within 24 hrs