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

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	Not specified	NCI	MDA-ID-030111 NCT00082706

Special Category: SPORE trial

Objectives

Primary

1. 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

1. 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

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• At least 6 weeks since prior pelvic irradiation
• No prior radiotherapy to more than 10% of the bone marrow

Surgery

• Not specified

Patient Characteristics:

Age

• Not specified

Performance status

• Zubrod 0-2*

 [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)
• At least 9 weeks (based on natural history of the cancer)

Hematopoietic

• Absolute neutrophil count ≥ 1,800/mm³*
• 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
• No other life-threatening illness that would preclude study completion
• No other malignancy that would preclude study participation

Expected Enrollment

A 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

Response rate
Overall survival

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		Ph: 713-792-2830; 800-392-1611 Email: asiefker@mdanderson.org

U.S.A.
Texas
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245

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

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