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Sponsored by: |
Fox Chase Cancer Center |
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Information provided by: | Fox Chase Cancer Center |
ClinicalTrials.gov Identifier: | NCT00350025 |
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 |
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Urologic Neoplasm |
Drug: cetuximab |
Phase II |
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 |
Estimated Enrollment: | 34 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | January 2009 |
Arms | Assigned Interventions |
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B
weekly cetuximab and paclitaxel
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Drug: cetuximab
weekly infusion of 250mg/m2
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Holly Tuttle, RN, MSN | 215-728-2451 | holly.tuttle@fccc.edu |
Contact: Judi Seldomridge, RN | 215-728-7413 | judi.seldomridge@fccc.edu |
United States, Pennsylvania | |
Fox Chase Cancer Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19111 | |
Principal Investigator: Yu-Ning Wong, MD |
Principal Investigator: | Yu-Ning Wong, MD | Fox Chase Cancer Center |
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 |
urothelial urologic neoplasm advanced metastatic |
Paclitaxel Cetuximab Urogenital Neoplasms Urologic Neoplasms Urinary tract neoplasm |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |