Study of Cetuximab With and Without Weekly Paclitaxel for Patients With Previously Treated Advanced Urothelial Cancer

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Cetuximab

Paclitaxel

About this trial

This is an interventional treatment trial for Urologic Neoplasm focused on measuring urothelial, urologic, neoplasm, advanced, metastatic

Eligibility Criteria

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

Inclusion Criteria: Histologically confirmed carcinoma of the urothelium (bladder,renal pelvis, ureter) Measurable disease by RECIST Patients who received only one prior systemic non-taxane regimen for urothelial cancer. May have received this in the adjuvant or neoadjuvant setting or for advanced disease. Signed IRB approved consent Must have tissue available for EGFR assessment and additional correlative studies ECOG PS 0-2 18 years of age or older Not of child bearing potential or negative pregnancy test within 7 days of treatment ANC greater than or equal to 1,500/ul Platelets greater than or equal to 100,00/ul Creatinine less than or equal to 2x institutional ULN or create. clearance greater than or equal to 30, bilirubin less than or equal to 1.5x ULN, AST&ALT less than or equal to 5x ULN Exclusion Criteria: Received more than one prior regimen for advanced disease Prior radiation to more than 30% of marrow containing skeleton Prior therapy that specifically and directly targets the EGFR pathway Prior severe infusion reaction to a monoclonal antibody, pre-existing neuropathy greater than or equal to grade 2 Prior reaction to Cremophor EL Known acute hepatitis B or C or known HIV Active or uncontrolled infection Significant history of uncontrolled cardiac disease Any concurrent chemotherapy not indicated in this study; or Any other investigational agents

Sites / Locations

Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Cetuximab alone

Cetuximab with Paclitaxel

Arm Description

Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy

Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

Response Rate, Duration of Response, Time to Progression Will be Assessed With Radiographic Imaging

Full Information

NCT ID

NCT00350025

First Posted

July 7, 2006

Last Updated

February 14, 2017

Sponsor

Fox Chase Cancer Center

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00350025

Brief Title

Study of Cetuximab With and Without Weekly Paclitaxel for Patients With Previously Treated Advanced Urothelial Cancer

Official Title

Randomized Phase II Trial of Cetuximab With and Without Weekly Paclitaxel in Patients With Previously Treated Advanced Urothelial Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fox Chase Cancer Center

Collaborators

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this research study is to determine whether the investigational drug cetuximab, (Erbitux) alone or with paclitaxel (Taxol) can stabilize the growth of urothelial cancer.

Detailed Description

This research study is being done to find out if cetuximab, alone or with paclitaxel will slow the growth of urothelial cancers. Cetuximab is an antibody that blocks a protein called epidermal growth factor receptor (EGFR). EGFR sits on the outside of tumor cells and controls tumor cell growth. This agent has been looked at alone and with other chemotherapy drugs including paclitaxel. It has been found to be safe and can shrink other types of cancer. This research study is also being done to find out if cetuximab, alone or with paclitaxel shrinks urothelial tumors. If it extends the time the tumors shrink. If it helps people live longer. The purpose of this research study is to find out what effects (good and bad) these treatments have on you and your cancer. We do not know if you will benefit from this research study. It is possible that your condition will get better, but it is also possible that there will be no effect on your condition or that your condition will get worse. We can use what we learn from this research study to help other people with the same disease.

6. Conditions and Keywords

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

Urologic Neoplasm

Keywords

urothelial, urologic, neoplasm, advanced, metastatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cetuximab alone

Arm Type

Other

Arm Description

Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy

Arm Title

Cetuximab with Paclitaxel

Arm Type

Other

Arm Description

Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Intervention Description

Cetuximab 250mg/m2 IV weekly for each 28 day cycle.

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

Taxol

Intervention Description

Paclitaxel 80mg/m2 IV weekly for each 28 day cycle.

Primary Outcome Measure Information:

Title

Progression Free Survival

Time Frame

Measures by CT scans following each 2 cycles of treatment and about every 8 weeks after off treatment for disease progression. Follow up for survival until time of death.

Secondary Outcome Measure Information:

Title

Response Rate, Duration of Response, Time to Progression Will be Assessed With Radiographic Imaging

Time Frame

Measured by CT scans after every 2 cycles of treatment (about every 8 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Histologically confirmed carcinoma of the urothelium (bladder,renal pelvis, ureter) Measurable disease by RECIST Patients who received only one prior systemic non-taxane regimen for urothelial cancer. May have received this in the adjuvant or neoadjuvant setting or for advanced disease. Signed IRB approved consent Must have tissue available for EGFR assessment and additional correlative studies ECOG PS 0-2 18 years of age or older Not of child bearing potential or negative pregnancy test within 7 days of treatment ANC greater than or equal to 1,500/ul Platelets greater than or equal to 100,00/ul Creatinine less than or equal to 2x institutional ULN or create. clearance greater than or equal to 30, bilirubin less than or equal to 1.5x ULN, AST&ALT less than or equal to 5x ULN Exclusion Criteria: Received more than one prior regimen for advanced disease Prior radiation to more than 30% of marrow containing skeleton Prior therapy that specifically and directly targets the EGFR pathway Prior severe infusion reaction to a monoclonal antibody, pre-existing neuropathy greater than or equal to grade 2 Prior reaction to Cremophor EL Known acute hepatitis B or C or known HIV Active or uncontrolled infection Significant history of uncontrolled cardiac disease Any concurrent chemotherapy not indicated in this study; or Any other investigational agents

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yu-Ning Wong, MD

Organizational Affiliation

Fox Chase Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

22927525

Citation

Wong YN, Litwin S, Vaughn D, Cohen S, Plimack ER, Lee J, Song W, Dabrow M, Brody M, Tuttle H, Hudes G. Phase II trial of cetuximab with or without paclitaxel in patients with advanced urothelial tract carcinoma. J Clin Oncol. 2012 Oct 1;30(28):3545-51. doi: 10.1200/JCO.2012.41.9572. Epub 2012 Aug 27. Erratum In: J Clin Oncol. 2013 Oct 1;31(28):3612.

Results Reference

result

Urologic Neoplasm

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial