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Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma

NCT01490437 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2014-09-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pemetrexed

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

DRUG

Cisplatin

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

DRUG

Dexamethasone

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

DRUG

Vitamins

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

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01490437 on ClinicalTrials.gov