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NCT Number: NCT01490437

Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma

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.

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Key information

Conditions

Urothelial Carcinoma Carcinoma Carcinoma, Transitional Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pemetrexed

Drug

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

Other names: Alimta

Cisplatin

Drug

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

Other names: cisplan

Dexamethasone

Drug

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

Other names: Dexa

vitamins

Drug

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

Primary outcomes

  1. Response rate

    Time frame: 12 months

    Based on RECIST v.1.0

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

A Prospective Phase 2 Study of PEmetrexed in Combination With Cisplatin in Patients With Advanced UrotheLIal CAnceR

Acronym: PECULIAR

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Dec 13, 2011
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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