Status:
COMPLETED
A Study of Gemzar, Taxotere, and Xeloda for Adjuvant Pancreatic Cancer
Lead Sponsor:
Columbia University
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The main purpose of this study will be to evaluate the toxicities as well as the efficacy of a chemotherapy regimen involving the combination of Gemzar, Taxotere, and Xeloda (GTX) in patients with pan...
Detailed Description
The adjuvant treatment of resected pancreatic cancer is currently in flux. Many in the United States continue to use 5FU-based chemotherapy with radiation to the pancreatic bed. Some in the States, an...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of pancreas that has been completely resected. Patients may be node negative or node-positive, but must have clean margins of resection.
- Ineligible for other high priority national or institutional studies.
- Time from surgical recovery greater than three weeks, but less than six weeks.
- All radiological evaluations (which must include either CT scans of the chest/abdomen/pelvis or a CT of the chest and a MRI of the abdomen/pelvis) must be performed within 4 weeks prior to the start of study therapy.
- 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.
- 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 6 months after completion of treatment. They must understand the risks of infertility possibly associated with adjuvant treatment.
- Clinical Parameters:
- Age ≥ 18 to ≤ 75 years old
- Performance status 0-2 (ECOG)
- Peripheral Neuropathy must be \< grade 1
- Able to tolerate oral medications
- Absolute Neutrophil Count \> 1,500 ul
- White Blood Count \> 3,000/ul
- Platelet count \> 100,000/ul
- BUN \< 1.5 x ULN
- Creatinine \< 1.5 x ULN
- Hemoglobin \> 8.0 g/dl
- Serum Albumin \> 2.5 mg/dl
- Total Bilirubin \< 3.0 mg/dl
- AST ≤4.0 x ULN
- ALT ≤4.0 x ULN
- Alkaline Phosphatase ≤4.0 x ULN\]
- CA 19-9 should be normal post surgery. Can still be put on protocol with elevation if clinically significant for inflammation or infection, not cancer
Exclusion
- Prior chemotherapy for their pancreatic cancer or radiation to the area of the tumor.
- Prior malignancies in last 5 years other than curatively treated carcinoma in-situ of any site in the body.
- Serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
- Patients with compromised immune systems are at increased risk of toxicity and lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients are excluded from the study.
- Any prior investigational agent/therapy or any investigational agent/therapy while on protocol.
- Hypersensitivity: Patients with a history of severe hypersensitivity reaction to Taxotere® or other drug formulated with polysorbate 80 will be excluded.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00882310
Start Date
September 1 2006
End Date
October 1 2014
Last Update
July 25 2016
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