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Phase II Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin in Subjects With Metastatic Pancreatic Cancer

Phase 2
18 Years
75 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Phase II Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin in Subjects With Metastatic Pancreatic Cancer

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
study requirements.

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary Outcome Measure

Outcome Description:

To assess the efficacy of the combination of gemcitabine, taxotere, and xeloda (GTX) with cisplatin in subjects with metastatic pancreatic cancer based on the progression-free survival (PFS) rate at 6 month.

Outcome Time Frame:

at 6 months

Safety Issue:


Principal Investigator

Dung Le, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins


United States: Institutional Review Board

Study ID:




Start Date:

November 2011

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms



Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410