Status:
COMPLETED
Gemcitabine/Taxotere/Xeloda (GTX) With Cisplatin in Subjects With Metastatic Pancreatic Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Swim Across America
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Primary Objectives 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 surv...
Eligibility Criteria
Inclusion
- Subjects must have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma. Subjects with islet cell neoplasms are excluded. Subjects with mixed histology will be excluded.
- Subject has one or more tumors measurable by CT scan using RECIST 1.1 criteria. MRI is acceptable if a CT scan is contraindicated.
- Patient must be chemotherapy naïve or must have completed chemotherapy greater than 5 years prior to enrollment.
- Male or non-pregnant and non-lactating female of age \>18 years
- 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
- Life expectancy of greater than 12 weeks.
- 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.
- 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.
- Willingness to undergo a tumor biopsy (implemented after the first 6 patients).
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Subjects who have had any prior chemotherapy within 5 years of enrollment
- Subjects who have had radiotherapy for pancreatic cancer.
- Age ≥ 76 years
- Subjects who are receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study.
- 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.
- Subject has known brain metastases unless previously treated and well controlled for at least 3 months (defined as stable clinically, no edema, no steroids).
- History of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, taxotere, xeloda, or cisplatin.
- 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.
- 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.
- Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Subject has a known history of infection with HIV, hepatitis B, or hepatitis C.
- Subject is pregnant or breast feeding.
- Subject is unwilling or unable to comply with study procedures.
- Subject with an unhealed surgical wound or other clinically significant wound.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01459614
Start Date
November 1 2011
End Date
November 1 2016
Last Update
May 19 2021
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21205