Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma (PECULIAR)

Asan Medical Center

Status and phase: Completed; Phase 2

Conditions: Urothelial Carcinoma

Treatments: Drug: Dexamethasone; Drug: Pemetrexed; Drug: Vitamins; Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01490437

UOSG-AMC-0804

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

PemCis

Experimental group

Description:

Pemetrexed plus Cisplatin

Treatment:

Drug: Cisplatin

Drug: Pemetrexed

Drug: Dexamethasone

Drug: Vitamins