 
***Trial Summary***
Short Title
Biochemically Synergistic Regimen for Metastatic Pancreatic Cancer (Stage IVB) 
with Gemzar, Taxotere and Xeloda (GTX)

Rationale
The evolution of this regimen, consisting of Gemzar, Taxotere and Xeloda (oral 
5FU) (GTX), was carefully developed over the past three years from laboratory 
and clinical work.   Initially the clinical effects of two agents, Gemzar and 
Taxotere, were assessed in pancreatic cancer patients.  Further studies were 
conducted researching some of the properties of gemcitabine, and Taxotere added 
to 5FU in vitro to maximize biochemical synergy and to minimize toxicity.  
Research found important characteristics of these drug combinations against 
pancreatic cancer cells that have been incorporated into the current protocol.  
Studies have also investigated many different combinations of these 3 agents in 
the laboratory to determine the best combination to achieve biochemical synergy 
while decreasing the concentration of each drug but maintaining equal anti-tumor 
effect so as to decrease toxicity to patients.

Treatment
Xeloda will be given orally twice daily Day 1 through Day 14
Gemzar will be given though an IV for 60 minutes on Day 4 and Day 11
Taxotere will be given though an IV for 60 minutes on Day 4 and Day 11

This 2-week regimen is followed by 1 week off for a total of a 21-day cycle.  
This is repeated for a total of 3 cycles before assessment of response is 
performed. A total period of 10 weeks is necessary before evaluation unless 
progression of disease occurs after cycle 2. Taxotere administration is preceded 
by 10 mg dexamethasone IV or p.o.  Scans will be done every 10 weeks (3 cycles 
plus an additional week)


Patient Abstract
<b>Trial Overview:</b> This is a phase II trial evaluating neoadjuvant Gemzar, 
Taxotere and Xeloda (GTX) and radiation with Gemzar in patients with stage IVA 
pancreatic adenocarcinoma.

<b>Trial Objectives:</b>
<i>Primary:</i> 
- To determine response rate to this regimen in patients with metastatic 
pancreatic cancer

<i>Secondary:</i>
- To determine overall and one year survival rates to this regimen in patients 
with metastatic pancreatic cancer.
- To determine disease free interval in patients with metastatic pancreatic 
cancer.
- To assess toxicities to this regimen.

***Health Professional Summary***
Full Title
Phase II Study of a Biochemically Synergistic Regimen for Metastatic Pancreatic 
Cancer (Stage IVB) with Gemzar, Taxotere and Xeloda (GTX)

Protocol Entry Criteria
 Histologically confirmed adenocarcinoma of the pancreas, metastatic to the 
liver and/or lungs or peritoneal surface (stage IVB).  
 NO prior chemo with Gemzar, Xeloda and Taxotere.  
 Greater than 3 weeks since surgery.
 Greater than 4 wks since radiation therapy.

***Trial Contact Info***
Site Name: Herbert Irving Comprehensive Cancer Center at New York Presbyterian 
Hospital
City: New York
State: NY
Protocol ID: 20031077
Contact Name: Robert Fine
email:  
phone: 212-305-1168
fax:  
