Clinical trial NCT00627432: Gemcitabine With Or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: stage III bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2008-03-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate
timeFrame: From baseline to the end of treatment, up to 6 months
Secondary outcomes:
measure: Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: From baseline to the end of treatment, up to 6 months
measure: Overall survival
timeFrame: From baseline to the end of treatment, up to 6 months
measure: Progression-free survival
timeFrame: From baseline to the end of treatment, up to 6 months
measure: Quality of life as assessed by QLQ-C30 and QLQ-LC13
timeFrame: From baseline to the end of treatment, up to 6 months
measure: Duration of response
timeFrame: From baseline to the end of treatment, up to 6 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Study officials:
affiliation: Institut du Cancer de Montpellier - Val d'Aurelle
name: Damien Pouessel, MD
role: STUDY_CHAIR
References: