Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer

NCT ID: NCT00101842

Last Updated: 2006-08-29

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

PHASE1/PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-07-31

Brief Summary

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The purposes of this study are: To determine the maximum tolerated dose of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine in patients with advanced or metastatic transitional cell carcinoma of the urothelium; To determine the safety of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine and any side effects that might be associated with the combination of these drugs; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can help patients with advanced bladder cancer live longer; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can make your tumor smaller or disappear, and for how long.

Detailed Description

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Conditions

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Carcinoma, Transitional Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pemetrexed

Intervention Type DRUG

Gemcitabine

Intervention Type DRUG

Platinol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Biopsy-proven metastatic bladder cancer
* No prior chemotherapy for metastatic disease except before or after surgery, which was completed 6 months before enrollment
* Prior radiation allowed, if it is not the only site of measurable disease and if completed 3 weeks before enrollment
* 18 years of age and older

Exclusion Criteria

* Pure adeno- or squamous urothelial cancer
* Brain metastases that causes symptoms
* Have not received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
* Inability to take dexamethasone, folic acid or vitamin B12, according to the protocol
* Clinically relevant fluid collection in the lungs or abdomen that cannot be controlled
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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H3E-US-S066

Identifier Type: -

Identifier Source: secondary_id

9439

Identifier Type: -

Identifier Source: org_study_id