Gemcitabine and Irinotecan in Treating Patients With Locally Advanced or Metastatic Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Phase II Study Of Gemcitabine And CPT-11 (Irinotecan) In Locally Advanced Or Metastatic Bladder Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00089128
• Other study ID #: CDR0000378047
• Secondary ID: MUSC-100615PHARM
• Status: Terminated
• Phase: Phase 2
• Start date: November 2001
• Est. completion date: November 2008

Study information

• Verified date: June 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• irinotecan hydrochloride

Locations

Country	Name	City	State
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Proportion		From registration until time of complete response or partial response
Secondary	Duration of Response		From registration until disease progression among patients who had at least a partial response.
Secondary	Frequency of Adverse Events as Assessed by NCI CTC Version 2.0		From the day of first dose until the end of study, an average of 6 months
Secondary	Progression-free Survival		Time between registration and disease progression or death, whichever comes first.