Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma

NCT01490437 | Completed Phase 2

• 1 other identifier: UOSG-AMC-0804
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Urothelial Carcinoma

Keywords

Advanced urothelial carcinoma

Outcome Measures

Primary Outcomes (1)

• Response rate

  Based on RECIST v.1.0

  12 months

Secondary Outcomes (3)

• Progression-free survival

  12 months

• Overall survival

  12 months

• Safety

  8 months

Study Arms (1)

PemCis

EXPERIMENTAL

Pemetrexed plus Cisplatin

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

Interventions

Pemetrexed DRUG

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

Also known as: Alimta

PemCis

Cisplatin DRUG

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

Also known as: cisplan

PemCis

Dexamethasone DRUG

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

Also known as: Dexa

PemCis

Vitamins DRUG

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

PemCis

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

• Choi YJ, Lee SH, Lee JL, Ahn JH, Lee KH, You D, Hong B, Hong JH, Ahn H. Phase II study of pemetrexed in combination with cisplatin in patients with advanced urothelial cancer: the PECULIAR study (KCSG 10-17). Br J Cancer. 2015 Jan 20;112(2):260-5. doi: 10.1038/bjc.2014.591. Epub 2014 Nov 27.

  PMID: 25429526 DERIVED

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Pemetrexed; Cisplatin; Dexamethasone; Absorptiometry, Photon; Vitamins

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 13, 2011
• Study Start: July 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

KR (1)