Suspended

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

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What is being tested

gemcitabine hydrochloride

+ irinotecan hydrochloride

Drug
Who is being recruted

Urogenital Diseases+8

+ Urinary Bladder Diseases

+ Urinary Bladder Neoplasms

From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: November 2001
See protocol details

Summary

Principal SponsorMedical University of South Carolina
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2001

Actual date on which the first participant was enrolled.

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.

Official TitlePhase II Study Of Gemcitabine And CPT-11 (Irinotecan) In Locally Advanced Or Metastatic Bladder Cancer 
NCT00089128
Principal SponsorMedical University of South Carolina
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesUrinary Bladder DiseasesUrinary Bladder NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsNeoplasmsNeoplasms by SiteUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital Diseases

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hollings Cancer Center at Medical University of South Carolina

Charleston, United StatesSee the location
SuspendedOne Study Center