Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00082706

Purpose

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, gemcitabine, and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin, gemcitabine, and cisplatin works in treating patients with metastatic or unresectable adenocarcinoma of the urothelium or urachal remnant (part of the bladder).

Condition	Intervention	Phase
Bladder Cancer Urethral Cancer	Drug: cisplatin Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: leucovorin calcium	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Trial of 5-FU, Leucovorin, Gemcitabine, and Cisplatin for Adenocarcinomas of the Urothelial Tract and Urachal Remnant

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer

Drug Information available for: Fluorouracil Leucovorin Cisplatin Citrovorum factor Gemcitabine Gemcitabine hydrochloride Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	46
Study Start Date:	April 2003

Detailed Description:

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.

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.

PROJECTED ACCRUAL: 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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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/mm^3*
Platelet count ≥ 150,000/mm^3* 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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082706

Locations

United States, Texas
M. D. Anderson Cancer Center at University of Texas	Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Arlene Siefker-Radtke, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000355828, MDA-ID-030111
Study First Received:	May 14, 2004
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00082706 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the bladder
recurrent bladder cancer
stage IV bladder cancer
recurrent urethral cancer

anterior urethral cancer
posterior urethral cancer
urethral cancer associated with invasive bladder cancer
stage III bladder cancer

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Leucovorin
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms by Site
Urologic Diseases
Cisplatin
Vitamins
Therapeutic Uses

Urethral Diseases
Micronutrients
Gemcitabine
Vitamin B Complex
Neoplasms by Histologic Type
Growth Substances
Urinary Bladder Diseases
Urinary Bladder Neoplasms
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on November 09, 2009