Status:
COMPLETED
Study for Inoperable Non-Metastatic Pancreatic CA (Stage IVA) With Neoadjuvant GTX, and Radiation With Gemzar
Lead Sponsor:
Columbia University
Conditions:
Pancreatic Cancer Stage IVA
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether an experimental drug combination consisting of Gemzar®, Taxotere®, and Xeloda®, (called GTX) when followed by radiation therapy plus low-dose Gemzar, ...
Detailed Description
The evolution of our regimen, consisting of Gemzar, Taxotere and Xeloda (oral 5FU) (GTX), was carefully developed over the past three years from laboratory and clinical work. Initially, in collaborati...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of pancreas localized to the pancreas, small bowel, stomach and/or encasing the superior mesenteric artery, vein or portal vein. (a.k.a. Stage IV A).
- No prior chemotherapy for their pancreatic cancer or radiation to the area of the tumor.
- Measurable disease: Any mass reproducibly measurable in two perpendicular diameters by x-ray, physical examination, CT or MRI scans.
- Ineligible for other high priority national or institutional studies
- Whipple surgery not allowed. Prior surgery is allowed as long as it was not pancreatic resection (i.e. Whipple surgery) and the time from surgical recovery is greater than three weeks.
- Non pregnant females who are not breast feeding with a negative serum β-HCG test within 1 week of starting the study. Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter.
- Clinical Parameters
- Life expectancy \> 2 months.
- Age 18 to 70 years old
- Performance status 0-2 (ECOG). (See Appendix IV)
- Peripheral Neuropathy must be \< grade 1
- Able to tolerate oral medications
- Absolute Neutrophil Count \> 1,500 μl
- White Blood Count \> 3,000/μl
- Platelet count \> 100,000/μl
- BUN \< 1.5 x normal
- Creatinine \< 1.5 normal
- Hemoglobin \> 8.0 g/dl
- Serum Albumin \> 2.5 mg/dl
- Total Bilirubin \< 5.0 mg/dl
- SGOT, SGPT, Alkaline Phosphatase \< 4.0 x ULN
Exclusion
- Hypersensitivity: Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80 must be excluded.
- Informed Consent: Each patient must be completely aware of the nature of his/her disease process and must willingly give consent after being informed of the experimental nature of the therapy, alternatives, potential benefits, side-effects, risks, and discomforts.
- Prior malignancies in last 5 years other than: curatively treated carcinoma in-situ of the cervix, non-melanoma skin cancer, prostate or DCIS (ductal carcinoma in-situ) previously treated successfully (cancer free)
- No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
- Patients known to have HIV will be excluded.
- Patients cannot have received any prior investigational agent/therapy, nor will they be allowed any investigational agent/therapy while on protocol.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00869258
Start Date
June 1 2005
End Date
October 1 2014
Last Update
June 22 2016
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032