Clinical trial NCT00089128: Gemcitabine and Irinotecan in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
Official title: Phase II Study Of Gemcitabine And CPT-11 (Irinotecan) In Locally Advanced Or Metastatic Bladder Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: transitional cell carcinoma of the bladder
recurrent bladder cancer
stage III bladder cancer
stage IV bladder cancer
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2004-08-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and irinotecan, 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 gemcitabine together with irinotecan works in treating patients with locally advanced or metastatic bladder cancer.

Detailed description: OBJECTIVES:

Primary

* Determine response in patients with locally advanced or metastatic transitional cell carcinoma of the bladder treated with gemcitabine and irinotecan.

Secondary

* Determine the duration of response in patients treated with this regimen.
* Determine the tolerance to and toxicity of this regimen in these patients.
* Determine the median and progression-free survival of patients treated with this regimen.

OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with responding disease receive 2 additional courses beyond best response.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 24 months.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed transitional cell carcinoma of the bladder

  * Locally advanced or metastatic disease
* Unidimensionally measurable disease by physical exam or imaging study

  * The following are not considered measurable disease:

    * Bone only disease
    * Pleural or peritoneal effusions
    * CNS lesions
    * Irradiated lesions unless disease progression was documented after radiotherapy
* Not amenable to surgery

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3

Hepatic

* Bilirubin ≤ 2.0 mg/dL

Renal

* Creatinine ≤ 2.0 mg/dL

Gastrointestinal

* No active inflammatory bowel disease
* No significant bowel obstruction
* No chronic diarrhea

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other active malignancy except nonmelanoma skin cancer
* No mental incapacitation or psychiatric illness that would preclude giving informed consent
* No other severe disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

* No more than 1 prior platinum-based chemotherapy regimen
* At least 4 weeks since prior chemotherapy
* No prior irinotecan or gemcitabine
* No other concurrent chemotherapy

Endocrine therapy

* No concurrent hormones except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), and intermittent dexamethasone as an antiemetic

Radiotherapy

* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No concurrent palliative radiotherapy

Surgery

* Not specified

Other

* No concurrent participation in another clinical trial

Primary outcomes:
measure: Response Proportion
timeFrame: From registration until time of complete response or partial response
Secondary outcomes:
measure: Duration of Response
timeFrame: From registration until disease progression among patients who had at least a partial response.
measure: Frequency of Adverse Events as Assessed by NCI CTC Version 2.0
timeFrame: From the day of first dose until the end of study, an average of 6 months
measure: Progression-free Survival
timeFrame: Time between registration and disease progression or death, whichever comes first.
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Hollings Cancer Center at Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Uzair B. Chaudhary, MD
role: STUDY_CHAIR
affiliation: Medical University of South Carolina, Hollings Cancer Center
name: Gustavo Leone
role: STUDY_CHAIR
References: