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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00350025
First received: July 7, 2006
Last updated: May 5, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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. ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]

Enrollment: 26
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
A
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.
B
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

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
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 7, 2006
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Paclitaxel
Cetuximab
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014