Study of Gemzar®, Taxotere®, and Xeloda® (GTX) in Patients With Metastatic Pancreatic Cancer (Stage IVB)
Completed · Phase 2
Conditions studied: Metastatic Pancreatic Cancer
In brief
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 and to study and enhance the utility of PET scans in the evaluation of patients with pancreatic cancer.
Key facts
- Study ID
- NCT00996333
- Run by
- Columbia University
- People needed
- 46
- Starts
- 2003-06-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2016-07-25
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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