Status:
COMPLETED
Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Sanofi
Conditions:
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study is designed to determine whether an investigational drug combination consisting of Gemzar®, Taxotere®, and Xeloda®, (called GTX) is safe and effective in treating advanced pancreatic cancer...
Detailed Description
This Phase II multicenter study is designed to determine the response rate to a biochemically synergistic regimen with Gemzar, Taxotere, and Xeloda in patients with Stage IVB metastatic pancreatic can...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of pancreas metastatic to liver and/or lungs or peritoneal surface. (a.k.a. Stage IV B).
- No prior chemotherapy with Gemzar, Xeloda and Taxotere.
- Measurable disease: Any mass reproducibly measurable in two perpendicular diameters by x-ray, physical examination, CT or MRI scans.
- The following lesions conventionally are not considered measurable:
- CNS lesions
- Blastic or lytic bone lesions (which should be documented and followed)
- Radiated lesions unless progression after RT is documented
- Ineligible for other high priority national or institutional studies
- Prior radiation and surgery allowed:
- \> 3 weeks since surgery
- \> 4 weeks since RT
- Non pregnant females who are not breast feeding with a negative serum or urine 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 - 70 years old
- Performance status 0-2 (ECOG)
- Peripheral Neuropathy must be \< grade 1
- Able to tolerate oral medications
- Required initial laboratory data:
- 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 \> 3 mg/dl
- Total Bilirubin \< 2.0 mg/dl
- SGOT, SGPT, Alkaline Phosphatase SGOT and SGPT may be up to 3.0 x ULN if Alk Phos \< 2.0 x ULN; or Alk Phos may be up to 3.0 x ULN if SGOT and SGPT are \< 2.0 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.
- The patient has not had a prior malignancy in last 5 years other than curatively treated carcinoma in-situ of the cervix or non-melanoma skin cancer
- No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
- Patients with brain metastases are excluded.
- Patients known to have HIV will be excluded.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00996333
Start Date
June 1 2003
End Date
October 1 2014
Last Update
July 25 2016
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032