Phase II Trial of 5-FU, Leucovorin, Gemcitabine, and Cisplatin for Adenocarcinomas of the Urothelial Tract and Urachal Remnant
The goal of this clinical research study is to learn if treatment with a combination of 4 chemotherapy drugs can help to shrink or slow the growth of adenocarcinoma. The drugs used in the combination chemotherapy are: 5-fluorouracil (5FU), leucovorin, gemcitabine, and cisplatin.
Disease Group: Bladder
Treatment Agent: 5-Fluorouracil
Treatment Location: Only at MD Anderson
Estimatated Length of Stay in Houston: 4-5 days every 3 weeks to receive chemotherapy.
Return Visit: Every 2 cycles (6 weeks)
Home Care: Chemotherapy may be given at home.
To estimate the response rate and overall survival of patients with metastatic or unresectable adenocarcinomas of the urothelial tract or urachal remnant who are treated with combination chemotherapy consisting of 5-FU, leucovorin, gemcitabine and cisplatin.
IRB Review and Approval Date: APR 16,2003
Recruitment Status: Closed
Projected Accrual: N/A
1) Histologic proof of cancer originating from the urinary tract with
adenocarcinoma as the predominant (>/= 50%) histology. Dr. Czerniak
and/or Dr. Tamboli will be consulted in equivocal cases of mixed
histology. The Study Chairman is the final arbiter in questions of mixed histology.
2) Bi-dimensionally measurable disease. All patients must have measurable or evaluable disease. In general, liver and lung lesions should be at least 1 cm, and patients with node-only disease should have lesions of >/= 1.5 cm in greatest dimension. Patients with disease confined to bone may be eligible if a measurable lytic defect, or soft-tissue component in present. Those without measurable disease may be eligible if a serum marker is elevated (>/= 4 x ULN) (ie: CEA, CA-125, CA19-9, bhCG, etc).
3) (# 2 cont'd) The Study Chairman is the final arbiter in questions related to measurability. Patients with a three-dimensional mass or pelvic sidewall fixation on bladder examination under anesthesia are considered to have measurable disease.
4) Patients are eligible if they have evidence of metastatic disease, or if their tumor is surgically unresectable. In the absence of grossly metastatic disease, all patients should be seen and evaluated by a member of the Urology staff to assess their potential for resection.
5) Patients must have adequate physiologic reserves as evidenced by: • Life expectancy of at least 9 months (based on co-morbidity) & at least 9 weeks based on the natural history of their cancer. • Zubrod Performance Status (PS) of </= 2; or 3 if of recent onset and due entirely to the cancer and not to cormorbidity, and especially if the compromised performance status is due to uncontrolled pain which is expected to be rapidly reversible when therapy starts.
6) (#5 cont'd) • Adequate bone marrow function as defined by absolute neutrophil count >/= 1,800 and platelet count >/= 150,000. Supranormal values judged to be of benign or inconsequential etiology are acceptable. • Transaminase (either SGPT or SGOT) </= 2x the upper limit of normal. • Conjugated bilirubin </= 2x the upper limit of normal. • Creatinine clearance (either measured or estimated using the formula of Cockcroft and Gault) of >/= 35 mL/min: CLcr = [(140-age) • wt(kg)]/[72 •Creat (mg/dL)] (For females, x 0.85)
7) Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of this hospital.
8) Patients must be at least 6 weeks out from pelvic irradiation, and must not have had more than 10% of the bone marrow irradiated.
9) Patients with a history of cardiac disease, or evidence of ischemic heart disease on EKG must have adequate cardiac function with an EF >/= 40% to participate.
10) Patient must be at least 18 years of age to participate in this study.
1) Patients with metastases to the bladder from a primary adenocarcinoma
arising outside the urinary tract are ineligible.
2) Overt psychosis or mental disability or otherwise incompetent to give informed consent.
3) A life threatening illness (unrelated to tumor) that would prevent completion of protocol therapy.
4) Pregnant or nursing women, as the drug therapy regimen, and support medications pose significant potential risks to the fetus and newborn.
5) Patients with second malignancies are eligible provided that the expected outcome from the second cancer is such that this will not interfere in the delivery of this therapy, or the assessment of response.
6) Patients with uncontrolled CNS metastases are not eligible.