Gemcitabine With Or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Phase 2 Randomized Study Evaluating the Efficacy of Gemcitabine With or Without Oxaliplatin in Patients With Advanced Urothelial Cancer That Cannot be Treated With Cisplatin-based Chemotherapy

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00627432
• Other study ID #: CDR0000574179
• Secondary ID: CLCC-VESUNFITREC
• Status: Suspended
• Phase: Phase 2
• First received: February 29, 2008
• Last updated: October 6, 2010
• Start date: July 2004

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying how well giving gemcitabine together with oxaliplatin works compared to gemcitabine alone in treating patients with locally advanced or metastatic bladder cancer.

Description:

OBJECTIVES:

Primary

• Determine the objective response rate in patients with advanced urothelial cancer treated with gemcitabine hydrochloride with vs without oxaliplatin.

Secondary

• Determine the tolerance of these regimens in these patients.

• Determine the overall survival and progression-free survival of patients treated with these regimens.

• Determine the quality of life of patients treated with these regimens.

• Determine the duration of response in patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive gemcitabine hydrochloride IV over 120 minutes on days 1, 8, and 15.

• Arm II: Patients receive gemcitabine IV over 100 minutes on days 1 and 15 and oxaliplatin IV over 120 minutes on days 2 and 16.

Treatment in both arms repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed urothelial carcinoma, or transitional cell carcinoma of the bladder or upper urinary tract

• Locally advanced disease (T4b) or metastatic disease (N2, N3, or M1)

• Unable to receive cisplatin-based chemotherapy due to creatinine clearance 30-60 mL/min or performance status 2

• At least 1 unidimensionally measurable lesion according to RECIST criteria

• No nonmeasurable lesions only, including any of the following:

• Ascites

• Pleural or pericardial effusion

• Bone metastases

• Lymphangitis

• No symptomatic cerebral metastases unless they have been stabilized

PATIENT CHARACTERISTICS:

• See Disease Characteristics

• Performance status 0-2

• ANC = 1,500/mm³

• Platelet count = 100,000/mm³

• Alkaline phosphatase = 2 times normal (unless bone metastases are present)

• Transaminases = 2 times normal (5 times normal if hepatic metastases present)

• Bilirubin = 1.5 times normal

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for at least 6 months after completion of treatment

• No prior malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer

• No peripheral neuropathy = grade 2

• No uncontrolled infection

• No other medical conditions that could interfere with evaluating tolerability, including any of the following:

• Congestive heart failure

• Angina pectoris that cannot be stabilized with medication

• Myocardial infarction within the past 12 months

• Serious thromboembolic disease

• No psychologic, social, or geographic reason that would make follow-up impossible

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy for advanced disease

• More than 4 weeks since prior radiotherapy to a target measurable lesion

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• oxaliplatin

Locations

Country	Name	City	State
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate			No
Secondary	Tolerability			Yes
Secondary	Overall survival			No
Secondary	Progression-free survival			No
Secondary	Quality of life as assessed by QLQ-C30 and QLQ-LC13			No
Secondary	Duration of response			No