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Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma (PECULIAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01490437
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : September 25, 2014
Information provided by (Responsible Party):
JLee, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Drug: Pemetrexed Drug: Cisplatin Drug: Dexamethasone Drug: Vitamins Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Phase 2 Study of PEmetrexed in Combination With Cisplatin in Patients With Advanced UrotheLIal CAnceR
Study Start Date : July 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01490437

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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: JLee, Associate Professor, Asan Medical Center Identifier: NCT01490437    
Other Study ID Numbers: UOSG-AMC-0804
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by JLee, Asan Medical Center:
Advanced urothelial carcinoma
Additional relevant MeSH terms:
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Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Physiological Effects of Drugs
Antineoplastic Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors