Pemetrexed and Cisplatin in Advanced Urothelial Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2013-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Urothelial Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PemCis

Pemetrexed plus Cisplatin

Group Type EXPERIMENTAL

Pemetrexed

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

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

Vitamins

Intervention Type DRUG

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

Interventions

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Pemetrexed

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

Intervention Type DRUG

Cisplatin

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

Intervention Type DRUG

Dexamethasone

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

Intervention Type DRUG

Vitamins

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

Intervention Type DRUG

Other Intervention Names

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Alimta cisplan Dexa

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No