Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01490437

Acronym

PECULIAR

Enrollment

Registered

2011-12-13

Start date

2008-07-31

Completion date

2013-12-31

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial Carcinoma

Keywords

Advanced urothelial carcinoma

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.

Interventions

DRUGPemetrexed

Pemetrexed 500 mg/m2 IV over 10 minutes on D1 every 3 weeks

DRUGCisplatin

Cisplatin 70 mg/m2 IV over 60 minutes on D1 every 21 days

DRUGDexamethasone

Dexamethasone 4 mg bid PO from D-1 to D2 every 3 weeks

DRUGVitamins

Folic acid 350 ug - 600 ug daily from D-7 daily vitamin B12 1,000 ug every 9 weeks from D-7

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Response rate	12 months	Based on RECIST v.1.0

Secondary

Measure	Time frame	Description
Progression-free survival	12 months	—
Overall survival	12 months	—
Safety	8 months	Based on NCI CTCAE v.3.0

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026