Pemetrexed Plus Cisplatin Bi-Weekly, in Patients With Urothelial Cancer (Metastatic, Locally Advanced or Non-Resectable)

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00374868

First received: September 11, 2006

Last updated: October 20, 2010

Last verified: October 2010

History of Changes

Results First Received: April 29, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Urologic Neoplasms
Interventions:	Drug: pemetrexed Drug: cisplatin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 59 participants entered the trial (21 in Phase 1 and 38 in Phase 2). Phase 1 determined the dose for Phase 2 to be 400 mg/m^2. Phase 2 results are reported.

Reporting Groups

	Description
Pemetrexed + Cisplatin	Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy

Participant Flow: Overall Study

	Pemetrexed + Cisplatin
STARTED	38
COMPLETED	2
NOT COMPLETED	36
Adverse Event	12
Progressive Disease	7
Physician Decision	13
Lost to Follow-up	1
Death	2
Other - Not Specified	1

Baseline Characteristics

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Reporting Groups

	Description
Pemetrexed + Cisplatin	Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy

Baseline Measures

	Pemetrexed + Cisplatin
Number of Participants [units: participants]	38
Age [units: years] Mean ± Standard Deviation	67.1 ± 8.7
Gender [units: participants]
Female	7
Male	31
Region of Enrollment [units: participants]
Spain	38
Eastern Cooperative Oncology Group (ECOG) Performance Status ^[1] [units: participants]
0 - Fully Active	21
1 - Ambulatory, Restricted Strenuous Activity	15
2 - Ambulatory, No Work Activities	2
Location of Primary Tumor [units: participants]
Bladder	32
Ureter	1
Urethra	1
Renal Pelvis	4
Height [units: centimeters] Mean ± Standard Deviation	166 ± 7.5
Weight [units: kilograms] Mean ± Standard Deviation	77.4 ± 13.2

[1]	Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).

Outcome Measures

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1. Primary:

Best Overall Tumor Response [ Time Frame: baseline to measured progressive disease (up to 620 days) ]

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2. Secondary:

Time to Response [ Time Frame: baseline to response (up to 620 days) ]

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3. Secondary:

Duration of Response [ Time Frame: time of response to progressive disease (up to 620 days) ]

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4. Secondary:

Duration of Stable Disease [ Time Frame: time of no response or progression (up to 620 days) ]

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Measure Type	Secondary
Measure Title	Duration of Stable Disease
Measure Description	Defined as time from study enrollment to the first progression of disease, complete response, partial response, or death from any cause. Complete response (CR) = disappearance of all target lesions. Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions. Stable disease (SD) = small changes that do not meet above criteria.
Time Frame	time of no response or progression (up to 620 days)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
1 patient was censored.

Reporting Groups

	Description
Pemetrexed + Cisplatin	Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy

Measured Values

	Pemetrexed + Cisplatin
Number of Participants Analyzed [units: participants]	38
Duration of Stable Disease [units: days] Median ( 95% Confidence Interval )	80 ( 71 to 103 )

No statistical analysis provided for Duration of Stable Disease

5. Secondary:

Time to Progressive Disease [ Time Frame: baseline to measured progressive disease (up to 620 days) ]

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6. Secondary:

Time to Treatment Failure (TTF) [ Time Frame: baseline to stopping treatment (up to 620 days) ]

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7. Secondary:

Progression-Free Survival [ Time Frame: baseline to measured progressive disease (up to 620 days) ]

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8. Secondary:

Overall Survival [ Time Frame: baseline to date of death from any cause (up to 620 days) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00374868 History of Changes
Other Study ID Numbers:	8679, H3E-ES-S085
Study First Received:	September 11, 2006
Results First Received:	April 29, 2009
Last Updated:	October 20, 2010
Health Authority:	Spain: Ministry of Health United States: Food and Drug Administration

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