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

Primary Purpose

Bladder Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
irinotecan hydrochloride
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring transitional cell carcinoma of the bladder, recurrent bladder cancer, stage III bladder cancer, stage IV bladder cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hollings Cancer Center at Medical University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine and Irnotecan

Arm Description

Outcomes

Primary Outcome Measures

Response Proportion

Secondary Outcome Measures

Duration of Response
Frequency of Adverse Events as Assessed by NCI CTC Version 2.0
Progression-free Survival

Full Information

First Posted
August 4, 2004
Last Updated
June 13, 2018
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT00089128
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
November 2001 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
transitional cell carcinoma of the bladder, recurrent bladder cancer, stage III bladder cancer, stage IV bladder cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine and Irnotecan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Primary Outcome Measure Information:
Title
Response Proportion
Time Frame
From registration until time of complete response or partial response
Secondary Outcome Measure Information:
Title
Duration of Response
Time Frame
From registration until disease progression among patients who had at least a partial response.
Title
Frequency of Adverse Events as Assessed by NCI CTC Version 2.0
Time Frame
From the day of first dose until the end of study, an average of 6 months
Title
Progression-free Survival
Time Frame
Time between registration and disease progression or death, whichever comes first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uzair B. Chaudhary, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gustavo Leone
Organizational Affiliation
Medical University of South Carolina, Hollings Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

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

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