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Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma (PECULIAR)

This study is currently recruiting participants.
Verified December 2011 by Asan Medical Center
Sponsor:
Collaborator:
Korea Association for Clinical Oncology
Information provided by (Responsible Party):
JLee, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01490437
First received: December 6, 2011
Last updated: December 13, 2011
Last verified: December 2011
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Response rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Based on RECIST v.1.0


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    Based on NCI CTCAE v.3.0


Estimated Enrollment: 44
Study Start Date: July 2008
Estimated Primary Completion Date: December 2012 (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
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490437

Contacts
Contact: Jae-Lyun Lee, MD, PhD 82 2 3010 5977 jaelyun@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Jae-Lyun Lee, MD, PhD     82 2 3010 5977     jaelyun@amc.seoul.kr    
Sub-Investigator: Hanjong Ahn, MD, PhD.            
Sub-Investigator: Jun-Hyuk Hong, MD, PhD.            
Sub-Investigator: Bum-Sik Hong, MD, PhD.            
Sub-Investigator: Cheryn Song, MD, PhD.            
Sub-Investigator: In-Gab Jeong, MD, PhD.            
Sub-Investigator: Choung Soo Kim, MD, PhD.            
Sub-Investigator: Jin-Hee Ahn, MD, PhD.            
Principal Investigator: Jae-Lyun Lee, MD, PhD.            
Sponsors and Collaborators
Asan Medical Center
Korea Association for Clinical Oncology
  More Information

No publications provided

Responsible Party: JLee, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01490437     History of Changes
Other Study ID Numbers: UOSG-AMC-0804
Study First Received: December 6, 2011
Last Updated: December 13, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Advanced urothelial carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pemetrexed
Cisplatin
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Vitamins
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Radiation-Sensitizing Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013