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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00350025
First Posted: July 10, 2006
Last Update Posted: March 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Fox Chase Cancer Center
  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 Drug: Paclitaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Cetuximab With and Without Weekly Paclitaxel in Patients With Previously Treated Advanced Urothelial Cancer

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • 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 Measures:
  • 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) ]

Enrollment: 41
Study Start Date: August 2006
Study Completion Date: September 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cetuximab alone
Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy
Drug: Cetuximab
Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
Cetuximab with Paclitaxel
Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.
Drug: Cetuximab
Cetuximab 250mg/m2 IV weekly for each 28 day cycle.
Drug: Paclitaxel
Paclitaxel 80mg/m2 IV weekly for each 28 day cycle.
Other Name: Taxol

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350025


Locations
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Fox Chase Cancer Center
Bristol-Myers Squibb
Investigators
Principal Investigator: Yu-Ning Wong, MD Fox Chase Cancer Center
  More Information

Publications:
Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00350025     History of Changes
Other Study ID Numbers: FER-GU-004
First Submitted: July 7, 2006
First Posted: July 10, 2006
Results First Submitted: December 21, 2016
Results First Posted: March 31, 2017
Last Update Posted: March 31, 2017
Last Verified: February 2017

Keywords provided by Fox Chase Cancer Center:
urothelial
urologic
neoplasm
advanced
metastatic

Additional relevant MeSH terms:
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Cetuximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action