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Phase II Study of Fluorouracil, Leucovorin Calcium, Gemcitabine, and Cisplatin in Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant
Basic Trial Information
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Protocol IDs
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Phase II
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Treatment
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Active
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Not specified
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NCI
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MDA-ID-030111
NCT00082706
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Special Category:
SPORE trial Objectives Primary - Determine the response rate and overall survival of patients with metastatic or unresectable adenocarcinoma of the urothelium or urachal remnant treated with fluorouracil, leucovorin calcium, gemcitabine, and cisplatin.
Secondary - Determine the toxicity of this regimen in these patients.
Entry Criteria Disease Characteristics:
- Histologically confirmed adenocarcinoma* of the urothelium or urachal remnant
- Metastatic or unresectable disease
[Note: *At least 50% of the histology must be adenocarcinoma]
- Measurable or evaluable disease*
- Bidimensionally measurable disease
- Liver and lung lesions at least 1 cm in greatest dimension
- Node-only disease at least 1.5 cm in greatest dimension
- Disease confined to the bone allowed provided a measurable lytic defect or soft-tissue component is present
- Three-dimensional mass or pelvic sidewall fixation on bladder examination under anesthesia is considered measurable disease
[Note: *Patients with no measurable disease allowed provided a serum marker (e.g., carcinoembryonic antigen, CA 125, CA19-9, or βhCG) is at least 4 times upper limit of normal (ULN)]
- No bladder metastases due to a primary adenocarcinoma arising outside the urinary tract
- No uncontrolled CNS metastases
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy Radiotherapy - At least 6 weeks since prior pelvic irradiation
- No prior radiotherapy to more than 10% of the bone marrow
Surgery Patient Characteristics:
Age Performance status [Note: *Zubrod 3 allowed if of recent onset and due entirely to the cancer and not to comorbidity] Life expectancy - At least 9 months (based on comorbidity)
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At least 9 weeks (based on natural history of the cancer)
Hematopoietic - Absolute neutrophil count ≥ 1,800/mm3*
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Platelet count ≥ 150,000/mm3*
[Note: *Supranormal values due to benign or inconsequential etiology allowed] Hepatic - SGPT or SGOT ≤ 2 times ULN
- Bilirubin ≤ 2 times ULN
Renal - Creatinine clearance ≥ 35 mL/min
Cardiovascular - Ejection fraction ≥ 50% for patients with a history of cardiac disease or ischemic heart disease on EKG
Other - Not pregnant or nursing
- No overt psychosis or mental disability that would preclude giving informed consent
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No other life-threatening illness that would preclude study completion
- No other malignancy that would preclude study participation
Expected Enrollment 46A total of 23-46 patients (7-18 with adenocarcinoma of the urachal remnant and 16-28 with adenocarcinoma of the urothelium) will be accrued for this study. Outcomes Primary Outcome(s)Response rate
Overall survival
Secondary Outcome(s)Toxicity
Outline Patients are stratified according to diagnosis (adenocarcinoma of the urothelium vs adenocarcinoma of the urachal remnant).
Patients receive fluorouracil IV continuously, leucovorin calcium IV once daily, and cisplatin IV once daily on days 1-5 and gemcitabine IV on days 1 and 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3-6 months.
Trial Contact Information
Trial Lead Organizations M. D. Anderson Cancer Center at University of Texas | | | | Arlene Siefker-Radtke, MD, Principal investigator | | | |
Trial Sites
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| U.S.A. |
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| Texas |
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Houston |
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| | | | | | | | | M. D. Anderson Cancer Center at University of Texas |
| | | Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas | |
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| Registry Information | | | Official Title | | Phase II Trial of 5-FU, Leucovorin, Gemcitabine, and Cisplatin for Adenocarcinomas of the Urothelial Tract and Urachal Remnant | | | Trial Start Date | | 2003-04-23 | | | Registered in ClinicalTrials.gov | | NCT00082706 | | | Date Submitted to PDQ | | 2003-10-24 | | | Information Last Verified | | 2007-07-03 | | | NCI Grant/Contract Number | | CA16672, CA91846 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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