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Clinical Trials: Detail

Title:	Phase II Study of a Biochemically Synergistic Regimen for Advanced Adenocarcinoma of the Biliary Tree with Gemzar, Taxotere and Xeloda (GTX)
Trial Start Date:	7/2/2007
Trial End Date:
Principal Investigator:	Robert Fine, MD
Description:	After initial presentation of the GTX regimen (in pancreatic cancer) a number of practitioners began using the regimen for pancreatic cancer patients. Several of these investigators began using the same regimen for patients with unresectable and metastatic biliary tree cancers such as cholangiocarcinoma. Personally, our group has treated 5 patients with the GTX regimen, and have documented 2 partial responses and 1 stable disease out of 3 patients with cholangiocarcinoma and 2 with gall bladder cancer. We therefore believe that it will show efficacy in this disease. The primary goals of this trial are to determine response rate to this regimen in patients with metastatic biliary tree cancers (stage 4) and to determine response rate to this regimen in patients with unresectable stage 3 biliary cancers.
Criteria:	Patients must fulfill the following criteria: 1) Histologically confirmed adenocarcinoma of the biliary tract including cholangiocarcinoma and gallbladder cancers. 2) Prior gemcitabine or 5FU bolus therapy is acceptable if given as adjuvant therapy after an initial resection. 3) Prior therapy with gemcitabine, Xeloda or docetaxel is acceptable if they only received and failed one of the 3 drugs. 4) Prior experimental drug therapies such as Phase I agents are acceptable. Measurable disease: Any mass reproducibly measurable in two perpendicular diameters by xray, 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 or last chemotherapy, >=4 weeks since RT. Non pregnant females who are not breast feeding with a negative serum or urine betaHCG 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 > 3 months. Age, between 18 70 years old; inclusively. Performance status, 02 (ECOG). Peripheral Neuropathy, must be =< grade 1. Able to tolerate oral medications. Required initial laboratory data: Absolute Neutrophil Count >= 1,500ul. White Blood Count >= 3,000/ul. Platelet count >= 100,000/ul. BUN =< 1.5 x normal. Creatinine =< 1.5 x normal. Hemoglobin >= 8.0 g/dl. Serum Albumin >= 3.0 mg/dl. Total Bilirubin =< 2.0 SGOT, SGPT, Alkaline Phosphatase, SGOT and SGPT may be up to 4.0x ULN if Alk Phos =< 2.5 ULN; or Alk Phos may be up to 4.0x ULN if SGOT and SGPT are =< 2.5 ULN. Hypersensitivity: Patients with a history of severe hypersensitivity reaction to docetaxel 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, sideeffects, risks, and discomforts. The patient cannot have had a prior malignancy in last 10 years other than curatively treated carcinoma insitu of the cervix or nonmelanoma skin cancer No serious medical or psychiatric illness preventing informed consent or intensive treatment (e.g., serious infection). Patients with brain metastases shall be excluded. Patients known to have HIV shall be excluded. 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.
URL:
Clinical Areas:	Pancreas; Liver
Contact:	For more information, please contact Joanna Martinez-Gomez, Phone: 212-305-9337 E-mail: jm2648@columbia.edu

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