Status:
TERMINATED
GTX Regimen for Biliary Cancers
Lead Sponsor:
Columbia University
Conditions:
Biliary Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a study for patients with advanced cancer of the biliary tree, such as cholangiocarcinoma. They will be treated with a chemotherapy regimen consisting of Gemcitabine, Taxotere, and Xeloda ever...
Detailed Description
After initial presentation of our data concerning this regimen (in pancreatic cancer) at the 2003 and 2004 ASCO meetings, a number of practitioners began using the regimen for pancreatic cancer patien...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the intrahepatic or extrahepatic biliary tract including cholangiocarcinoma, gallbladder cancer and ampullary cancer (ampula of vater).
- Prior therapy with gemcitabine, Xeloda or docetaxel is acceptable if he/she only received and failed one of the 3 drugs.
- Prior experimental drug therapies such as Phase I agents are acceptable.
- Measurable disease: Any mass measurable by RECIST 1.1 parameters by CT or MRI scans of metastatic and primary tumor sites
- Ineligible for other high priority national or institutional studies
- Prior radiation and surgery allowed:
- 3 weeks since surgery or last chemotherapy
- 4 weeks since RT
- Non pregnant females with a negative serum β-HCG test within 1 week of starting the study, who are not breast feeding. 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 \> 3 months Age ≥ 18 y.o Performance status 0-2 (ECOG) (See Appendix IV) Peripheral Neuropathy must be ≤ grade 1 Able to tolerate oral chemotherapeutic medications
- Required initial laboratory data
- CBC with Differential Basic Metabolic Panel (BMP) Liver Function Tests (LFTs) Serum β-HCG (non-menopausal females) Tumor Specific Tests Hepatitis B and C Tests Pulse Oximetry on Room Air \>90%
- 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.
Exclusion
- Hypersensitivity: Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 must be excluded.
- Prior malignancy in last 5 years other than: curatively treated carcinoma in-situ of the cervix, non-melanoma skin cancer, DCIS (ductal carcinoma in situ) or early stage (I or II) prostate cancer previously treated with curative intent by radiation and/or surgery and is now cancer free.
- Known serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection).
- Patients with CNS metastases shall be excluded.
- 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.
- Patients with currently active inflammatory bowel disease (ulcerative colitis, Crohn's) or sclerosing cholangitis will be excluded. A history of these IBD's or sclerosing cholangitis is acceptable if the disease is in remission or quiescent.
- Active infection with non-A hepatitis virus (Hepatitis B and C) will be excluded
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00868998
Start Date
August 1 2005
End Date
October 1 2010
Last Update
May 23 2016
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032