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Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma (PECULIAR)

This study has been completed.
Information provided by (Responsible Party):
JLee, Asan Medical Center Identifier:
First received: December 6, 2011
Last updated: September 22, 2014
Last verified: September 2014

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.

Condition Intervention Phase
Urothelial Carcinoma
Drug: Pemetrexed
Drug: Cisplatin
Drug: Dexamethasone
Drug: Vitamins
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Phase 2 Study of PEmetrexed in Combination With Cisplatin in Patients With Advanced UrotheLIal CAnceR

Resource links provided by NLM:

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Response rate [ Time Frame: 12 months ]
    Based on RECIST v.1.0

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 12 months ]
  • Overall survival [ Time Frame: 12 months ]
  • Safety [ Time Frame: 8 months ]
    Based on NCI CTCAE v.3.0

Enrollment: 42
Study Start Date: July 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PemCis
Pemetrexed plus Cisplatin
Drug: Pemetrexed
Pemetrexed 500 mg/m2 IV over 10 minutes on D1 every 3 weeks
Other Name: Alimta
Drug: Cisplatin
Cisplatin 70 mg/m2 IV over 60 minutes on D1 every 21 days
Other Name: cisplan
Drug: Dexamethasone
Dexamethasone 4 mg bid PO from D-1 to D2 every 3 weeks
Other Name: Dexa
Drug: Vitamins
Folic acid 350 ug - 600 ug daily from D-7 daily vitamin B12 1,000 ug every 9 weeks from D-7


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01490437

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: JLee, Associate Professor, Asan Medical Center Identifier: NCT01490437     History of Changes
Other Study ID Numbers: UOSG-AMC-0804
Study First Received: December 6, 2011
Last Updated: September 22, 2014

Keywords provided by Asan Medical Center:
Advanced urothelial carcinoma

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antineoplastic Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Growth Substances
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors processed this record on April 26, 2017