Back to results

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

Primary Purpose

Carcinoma, Transitional Cell

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Pemetrexed

Gemcitabine

Platinol

About this trial

This is an interventional treatment trial for Carcinoma, Transitional Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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.

Outcomes

Primary Outcome Measures

Toxicity will be measured by standard grading methods.

Secondary Outcome Measures

Response will be measured by Response Evaluation Criteria in Solid Tumors (RECIST).

Duration of response is defined as time from first objective assessment of CR or PR to first time of progression or death from any cause.

Time to progressive disease is defined as time from enrollment to first date of disease progression.

Time to treatment failure is defined as time from enrollment to first observation of disease progression, death of any cause or early discontinuation of treatment.

Survival time is defined as time from enrollment to death from any cause.

Full Information

NCT ID

NCT00101842

First Posted

January 14, 2005

Last Updated

August 24, 2006

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00101842

Brief Title

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

Official Title

Phase I/II Study of Gemzar and Platinol Followed by Alimta and Gemzar in Patients With Advanced or Metastatic Bladder Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2006

Overall Recruitment Status

Completed

Study Start Date

December 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Transitional Cell

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

61 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Type

Drug

Intervention Name(s)

Platinol

Primary Outcome Measure Information:

Title

Toxicity will be measured by standard grading methods.

Secondary Outcome Measure Information:

Title

Response will be measured by Response Evaluation Criteria in Solid Tumors (RECIST).

Title

Duration of response is defined as time from first objective assessment of CR or PR to first time of progression or death from any cause.

Title

Time to progressive disease is defined as time from enrollment to first date of disease progression.

Title

Time to treatment failure is defined as time from enrollment to first observation of disease progression, death of any cause or early discontinuation of treatment.

Title

Survival time is defined as time from enrollment to death from any cause.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Dallas

State/Province

Texas

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs