Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Urologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Cetuximab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

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.

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

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

Yu-Ning Wong, MD

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.

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.

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

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

Bristol-Myers Squibb

Fox Chase Cancer Center

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

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

Arm A - Cetuximab Treatment Arm

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

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

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

Arm B Paclitaxel and Cetuximab Combination Treatment Arm

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

ECOG scale of performance status was used to determine the ability of the patients to perform their daily functions.

Grade(0)- Fully active Grade (1)- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature Grade (2)- Ambulatory and capable of all selfcare but unable to carry out any work activities Grade (3)- Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours Grade (4) -Completely disabled Grade (5)- Dead

Performance Status

Bladder

Renal Pelvis

Primary site, No. of patients

Gemcitabine and Platinum

MVAC

Previous Chemotherapy, No. of Patients

Dr. Yu-Ning Wong

Progression Free Survival

Overall Survival

Overall Response Rate

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

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Cetuximab With and Without Weekly Paclitaxel for Patients With Previously Treated Advanced Urothelial Cancer	NCT00350025	Urologic Neopla...	Cetuximab Paclitaxel	18 Years -	Fox Chase Cancer Center
Study of Cetuximab With and Without Weekly Paclitaxel for Patients With Previously Treated Advanced Urothelial Cancer	NCT00350025	Urologic Neopla...	Cetuximab Paclitaxel	18 Years -	Fox Chase Cancer Center

Spots Global Cancer Trial Database for urologic neoplasm