Randomized Phase II Study for Patients With Previously Treated Advanced Urothelial Cancer - Full Text View

Sponsored by:	Fox Chase Cancer Center
Information provided by:	Fox Chase Cancer Center
ClinicalTrials.gov Identifier:	NCT00350025

Purpose

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.

Condition	Intervention	Phase
Urologic Neoplasm	Drug: cetuximab	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Paclitaxel Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Phase II Trial fo Cetuximab With and Without Weekly Paclitaxel in Patients With Previously Treated Advanced Urothelial Cancer

Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:

Progression free survival [ Time Frame: End of every second cycle ]

Secondary Outcome Measures:

Response rate, duration of response, time to progression will be assessed with radiographic imaging after every 2 cycles.

Estimated Enrollment:	34
Study Start Date:	August 2006
Estimated Study Completion Date:	January 2009

Arms	Assigned Interventions
B weekly cetuximab and paclitaxel	Drug: cetuximab weekly infusion of 250mg/m2

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed carcinoma of the urothelium (bladder,renal pelvis, ureter)
Measurable disease by RECIST
One prior regimen for advanced or metastatic disease but must not have received prior taxane therapy for metastatic disease
May have received prior adjuvant therapym prior paclitaxel or docetaxel as part of adjuvant chemo is permitted if patient progressed within 9 months of completion of neoadjuvant or adjuvant therapy
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350025

Contacts

Contact: Holly Tuttle, RN, MSN	215-728-2451	holly.tuttle@fccc.edu
Contact: Judi Seldomridge, RN	215-728-7413	judi.seldomridge@fccc.edu

Locations

United States, Pennsylvania
Fox Chase Cancer Center	Recruiting
Philadelphia, Pennsylvania, United States, 19111
Principal Investigator: Yu-Ning Wong, MD

Sponsors and Collaborators

Fox Chase Cancer Center

Investigators

Principal Investigator:

Yu-Ning Wong, MD

Fox Chase Cancer Center

More Information

Study ID Numbers:	FER-GU-004
Study First Received:	July 7, 2006
Last Updated:	November 1, 2007
ClinicalTrials.gov Identifier:	NCT00350025
Health Authority:	United States: Institutional Review Board

Keywords provided by Fox Chase Cancer Center:

urothelial
urologic
neoplasm
advanced
metastatic

Study placed in the following topic categories:

Paclitaxel
Cetuximab
Urogenital Neoplasms
Urologic Neoplasms
Urinary tract neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009