Phase II Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin in Subjects With Metastatic Pancreatic Cancer
- 1. Subjects must have histologically or cytologically confirmed metastatic pancreatic
adenocarcinoma. Subjects with islet cell neoplasms are excluded. Subjects with mixed
histology will be excluded.
- 2. Subject has one or more tumors measurable by CT scan using RECIST 1.1 criteria.
MRI is acceptable if a CT scan is contraindicated.
- 3. Patient must be chemotherapy naïve or must have completed chemotherapy greater
than 5 years prior to enrollment.
- 4. Male or non-pregnant and non-lactating female of age >18 years
- 5. ECOG performance status <1. ECOG 0 indicates that the patient is fully active and
able to carry on all pre-disease activities without restriction; and, ECOG 1
indicates that the patient is restricted in physically strenuous activity but is
ambulatory and able to carry out work of a light or sedentary nature
- 6. Life expectancy of greater than 12 weeks.
- 7. Subjects must have adequate organ and marrow function as defined below: WBC ≥
3,500/mcL Absolute Neutrophil Count ≥1,500/mcL Platelets ≥100 x 10^9/L Hemoglobin ≥
9 g/d Total Bilirubin within normal institutional limits Alkaline phosphatase ≤ 2.5 x
ULN (≤ 5 X ULN for subjects with documented liver metastases) AST(SGOT)/ALT(SGPT) ≤
2.5 x ULN (≤ 5 X ULN for subjects with documented liver metastases) Creatinine
within normal institutional limits OR Creatinine clearance ≥ 60 mL/min/1.73 m2 for
subjects with creatinine levels above institutional normal.
- 8. Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation. Should a woman become pregnant or suspect
she is pregnant while she or her partner is participating in this study, she should
inform her treating physician immediately.
- 9. Willingness to undergo a tumor biopsy (implemented after the first 6 patients).
- 10. Ability to understand and the willingness to sign a written informed consent
- 1. Subjects who have had any prior chemotherapy within 5 years of enrollment
- 2. Subjects who have had radiotherapy for pancreatic cancer.
- 3. Age ≥ 76 years
- 4. Subjects who are receiving or have received any other investigational agents
within 28 days prior to Day 1 of treatment in this study.
- 5. Subject has undergone major surgery, other than diagnostic surgery (i.e.--surgery
done to obtain a biopsy for diagnosis or an aborted Whipple), within 28 days prior to
Day 1 of treatment in this study.
- 6. Subject has known brain metastases unless previously treated and well controlled
for at least 3 months (defined as stable clinically, no edema, no steroids).
- 7. History of hypersensitivity or allergic reactions attributed to compounds of
similar chemical or biologic composition to gemcitabine, taxotere, xeloda, or
- 8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
- 9. Subject has serious medical risk factors involving any of the major organ systems
such that the Investigator considers it unsafe for the subject to receive an
experimental research drug.
- 10. Subject has active, uncontrolled bacterial, viral, or fungal infection(s)
requiring systemic therapy.
- 11. Subject has a known history of infection with HIV, hepatitis B, or hepatitis C.
- 12. Subject is pregnant or breast feeding.
- 13. Subject is unwilling or unable to comply with study procedures.
- 14. Subject with an unhealed surgical wound or other clinically significant wound.