Oxaliplatin in Treating Patients With Metastatic Bladder Cancer

Sponsor

University of Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT00004203

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

1.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have metastatic bladder cancer.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter	Drug: oxaliplatin	Phase 2

Detailed Description

OBJECTIVES: I. Determine the response rate, duration of response, and overall survival of patients with metastatic urothelial carcinoma treated with oxaliplatin. II. Determine the toxicity, including objective measurement of neurotoxicity, of oxaliplatin in these patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified by platinum therapy status (platinum sensitive vs platinum resistant). Patients receive oxaliplatin IV over 2 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression, other illness that would preclude administration of study drug, or unacceptable toxicity. Patients are followed for a minimum of 2 years or until death.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 2 years.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Oxaliplatin in Urothelial Cancer

Study Start Date :

Feb 1, 2000

Actual Primary Completion Date :

Feb 1, 2002

Actual Study Completion Date :

Apr 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A On Day 1 of each 21-day treatment cycle, patients receive 130 mg/m2 oxaliplatin diluted in 250 to 500 mL Dextrose 5% in Water infused intravenously over 2 hours through a peripheral or central vein	Drug: oxaliplatin

Arm

Intervention/Treatment

Experimental: Arm A

On Day 1 of each 21-day treatment cycle, patients receive 130 mg/m2 oxaliplatin diluted in 250 to 500 mL Dextrose 5% in Water infused intravenously over 2 hours through a peripheral or central vein

Drug: oxaliplatin

Outcome Measures

Primary Outcome Measures

Response Rate of Metastatic Urothelial cancer to a single agent oxaliplatin [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically or cytologically proven metastatic urothelial carcinoma Bidimensionally measurable disease Platinum sensitive OR platinum resistant Platinum sensitive disease: No prior platinum containing regimen OR Progressive or recurrent disease more than 6 months after responding to a platinum containing regimen Platinum resistant disease: Progressive or recurrent disease within 6 months of a platinum containing regimen (cisplatin or carboplatin) No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 50-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal SGOT or SGPT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 30 mL/min Cardiovascular: No uncontrolled concurrent illness including, but not limited to: Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Other: No clinical evidence of neuropathy worse than grade 1 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No allergy to platinum compounds or antiemetics No uncontrolled concurrent illness including, but not limited to, an active infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors during the first course of study therapy Chemotherapy: See Disease Characteristics One prior chemotherapy regimen for metastatic disease allowed Prior neoadjuvant or adjuvant chemotherapy regimen allowed if the interval between this therapy and the first therapy for metastatic disease was at least 6 months At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents No HIV positive patients receiving antiretroviral therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Chicago	Chicago	Illinois	United States	60612
2	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
3	Louis A. Weiss Memorial Hospital	Chicago	Illinois	United States	60640
4	Cancer Care Specialists of Central Illinois, S.C.	Decatur	Illinois	United States	62526
5	Evanston Northwestern Health Care	Evanston	Illinois	United States	60201
6	Division of Hematology/Oncology	Park Ridge	Illinois	United States	60068
7	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois	United States	61602
8	Central Illinois Hematology Oncology Center	Springfield	Illinois	United States	62701
9	Fort Wayne Medical Oncology and Hematology, Inc.	Fort Wayne	Indiana	United States	46885-5099
10	Michiana Hematology/Oncology P.C.	South Bend	Indiana	United States	46617
11	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104-4283
12	Cancer Care Ontario-Hamilton Regional Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
13	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario	Canada	N6A 4L6
14	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9