Bladder CancerPhase 2NCT00082706
Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant
A Phase 2 study testing 5-Fluorouracil (5-FU), Leucovorin and Cisplatin in people with Bladder Cancer and Urethral Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, gemcitabine, and cisplatin, 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Urethral Cancer, Urachal Cancer
- What is being tested?
- 5-Fluorouracil (5-FU), Leucovorin and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2003to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic proof of cancer originating from the urinary tract with adenocarcinoma as the predominant (>/= 50%) histology. Dr. Czerniak and/or Dr. Tamboli will be consulted in equivocal cases of mixed histology. The Study Chairman is the final arbiter in questions of mixed histology.
- Bi-dimensionally measurable disease. All patients must have measurable or evaluable disease. In general, liver and lung lesions should be at least 1 cm, and patients with node-only disease should have lesions of >/= 1.5 cm in greatest dimension. Patients with disease confined to bone may be eligible if a measurable lytic defect, or soft-tissue component in present. Those without measurable disease may be eligible if a serum marker is elevated (>/= 4 x ULN) (ie: CEA, CA-125, CA19-9, bhCG, etc).
- (# 2 cont'd) The Study Chairman is the final arbiter in questions related to measurability. Patients with a three-dimensional mass or pelvic sidewall fixation on bladder examination under anesthesia are considered to have measurable disease.
- Patients are eligible if they have evidence of metastatic disease, or if their tumor is surgically unresectable. In the absence of grossly metastatic disease, all patients should be seen and evaluated by a member of the Urology staff to assess their potential for resection.
- Patients must have adequate physiologic reserves as evidenced by: • Life expectancy of at least 9 months (based on co-morbidity) \& at least 9 weeks based on the natural history of their cancer. • Zubrod Performance Status (PS) of </= 2; or 3 if of recent onset and due entirely to the cancer and not to comorbidity, and especially if the compromised performance status is due to uncontrolled pain which is expected to be rapidly reversible when therapy starts.
- (#5 cont'd) • Adequate bone marrow function as defined by absolute neutrophil count >/= 1,800 and platelet count >/= 150,000. Supranormal values judged to be of benign or inconsequential etiology are acceptable. • Transaminase (either SGPT or SGOT) </= 2x the upper limit of normal. • Conjugated bilirubin </= 2x the upper limit of normal. • Creatinine clearance (either measured or estimated using the formula of Cockcroft and Gault) of >/= 35 mL/min: CLcr = [(140-age) • wt(kg)]/[72 •Creat (mg/dL)] (For females, x 0.85)
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- Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of this hospital.
- Patients must be at least 6 weeks out from pelvic irradiation, and must not have had more than 10% of the bone marrow irradiated.
- Patients with a history of cardiac disease, or evidence of ischemic heart disease on EKG must have adequate cardiac function with an EF >/= 40% to participate.
- Patient must be at least 18 years of age to participate in this study.
Who cannot join
- Patients with metastases to the bladder from a primary adenocarcinoma arising outside the urinary tract are ineligible.
- Overt psychosis or mental disability or otherwise incompetent to give informed consent.
- A life threatening illness (unrelated to tumor) that would prevent completion of protocol therapy.
- Pregnant or nursing women, as the drug therapy regimen, and support medications pose significant potential risks to the fetus and newborn.
- Patients with second malignancies are eligible provided that the expected outcome from the second cancer is such that this will not interfere in the delivery of this therapy, or the assessment of response.
- Patients with uncontrolled CNS metastases are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
About this study
Official title: Phase II Trial of 5-FU, Leucovorin, Gemcitabine, and Cisplatin for Adenocarcinomas of the Urothelial Tract and Urachal Remnant
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, gemcitabine, and cisplatin, 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 fluorouracil together with leucovorin, gemcitabine, and cisplatin works in treating patients with metastatic or unresectable adenocarcinoma of the urothelium or urachal remnant (part of the bladder).
Read the detailed description
OBJECTIVES:
Primary
- Determine the response rate and overall survival of patients with metastatic or unresectable adenocarcinoma of the urothelium or urachal remnant treated with fluorouracil, leucovorin calcium, gemcitabine, and cisplatin.
Secondary
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to diagnosis (adenocarcinoma of the urothelium vs adenocarcinoma of the urachal remnant).
Patients receive fluorouracil by vein (IV) continuously, leucovorin calcium IV once daily, and cisplatin IV once daily on days 1-5 and gemcitabine IV on days 1 and 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3-6 months.
PROJECTED ACCRUAL: A total of 23-46 patients (7-18 with adenocarcinoma of the urachal remnant and 16-28 with adenocarcinoma of the urothelium) will be accrued for this study.
- Conditions
- Bladder Cancer, Urethral Cancer, Urachal Cancer
- Being tested
- 5-Fluorouracil (5-FU), Leucovorin, Cisplatin, Gemcitabine
- Keywords
- adenocarcinoma of the bladder, recurrent bladder cancer, stage IV bladder cancer, recurrent urethral cancer, anterior urethral cancer, posterior urethral cancer, urethral cancer associated with invasive bladder cancer, stage III bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms, Urethral Neoplasms, Urachal cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Fluorouracil (5-FU)Drug
Also called 5-FU, Adrucil, Efudex
Day: 1 - 5 Dose: 200 mg/m2 IVCI daily x 5 days
LeucovorinDrug
Also called Citrovorum, Wellcovorin
Day: 1 - 5 Dose:10 mg/m2 daily x 5 days
CisplatinDrug
Also called Platinol-AQ, Platinol, CDDP
Day: 1 - 5 Dose: 20 mg/m2 daily x 5 days
GemcitabineDrug
Also called Gemcitabine Hydrochloride, Gemzar
Day: 1 \& 5 Dose: 200 mg/m2 (Two doses only)
| Study group | Role | What they receive |
|---|---|---|
| 5-FU, Leucovorin, Gemcitabine + Cisplatin | Experimental | 5-FU continuous infusion over Days 1 - 5; Leucovorin once a day as a short infusion on Days 1 - 5; Cisplatin infusion over a few hours (usually 2-4 hours) once a day on Days 1 - 5; Gemcitabine infusion over 30 minutes on Days 1 \& 5 only. Receives: Drug: 5-Fluorouracil (5-FU); Drug: Leucovorin; Drug: Cisplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Response
Complete Response: Participants counted as complete response if they have no radiological evidence of tumor, have no signs or symptoms of disease, and have normalized tumor markers (in those with initially elevated markers). Participants with an intact, tumor-containing bladder, must have a cystoscopy and exam under anesthesia to confirm a complete response. Partial response: Any response less than a complete response. Progressive disease: Progressive disease is at least 25% increase in tumor volume, or any new site of involvement, including the CNS. Increasing severity of symptoms, if judged by treating physician to be due to progressive disease, also counted as progression, even if these are not accompanied by an "objective" indicator. Any unequivocal increase (i.e. to greater than 5 mi.u./mL in beta-hCG) in a male patient taken to represent progressive disease, as will two consecutive rises amounting to a total of at least 125% of baseline for any other tumor marker.
Measured: Every 2 cycles (6 weeks)
Secondary outcomes (1)
Number of Patients with Dose-Limiting Toxicity
For each single arm trial, a stopping boundary also imposed to monitor toxicity of the new combination chemotherapy. Trial should be stopped for the 90% probability that the dose-limiting toxicity is greater than 40%. Participants monitored in groups of 3 sequentially. Stopping boundary obtained using a Bayesian monitoring rule.
Measured: Continous assessment during 21 day cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2004 (estimated)
- Study start23 Apr 2003
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Arlene Siefker-Radtke, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082706
- Sponsor's protocol ID
- ID03-0111
- Other IDs
- P50CA091846, ID-030111, CDR0000355828, NCI-2012-01305
- Status last verified
- Sep 2025
- First submitted
- 14 May 2004
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of 5-FU, Leucovorin, Gemcitabine, and Cisplatin for Adenocarcinomas of the Urothelial Tract and Urachal Remnant
- ClinicalTrials.gov ID
- NCT00082706
- Acronym / sponsor ID
- ID03-0111
- Conditions
- Bladder Cancer, Urethral Cancer, Urachal Cancer
- Keywords
- adenocarcinoma of the bladder, recurrent bladder cancer, stage IV bladder cancer, recurrent urethral cancer, anterior urethral cancer, posterior urethral cancer, urethral cancer associated with invasive bladder cancer, stage III bladder cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 46 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Apr 2003 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, gemcitabine, and cisplatin, 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 fluorouracil together with leucovorin, gemcitabine, and cisplatin works in treating patients with metastatic or unresectable adenocarcinoma of the urothelium or urachal remnant (part of the bladder).
Detailed description
OBJECTIVES:
Primary
- Determine the response rate and overall survival of patients with metastatic or unresectable adenocarcinoma of the urothelium or urachal remnant treated with fluorouracil, leucovorin calcium, gemcitabine, and cisplatin.
Secondary
- Determine the toxicity of this regimen in these patients.
OUTLINE: Patients are stratified according to diagnosis (adenocarcinoma of the urothelium vs adenocarcinoma of the urachal remnant).
Patients receive fluorouracil by vein (IV) continuously, leucovorin calcium IV once daily, and cisplatin IV once daily on days 1-5 and gemcitabine IV on days 1 and 5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3-6 months.
PROJECTED ACCRUAL: A total of 23-46 patients (7-18 with adenocarcinoma of the urachal remnant and 16-28 with adenocarcinoma of the urothelium) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5-FU, Leucovorin, Gemcitabine + Cisplatin | Experimental | Drug: 5-Fluorouracil (5-FU), Drug: Leucovorin, Drug: Cisplatin, Drug: Gemcitabine5-FU continuous infusion over Days 1 - 5; Leucovorin once a day as a short infusion on Days 1 - 5; Cisplatin infusion over a few hours (usually 2-4 hours) once a day on Days 1 - 5; Gemcitabine infusion over 30 minutes on Days 1 \& 5 only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologic proof of cancer originating from the urinary tract with adenocarcinoma as the predominant (>/= 50%) histology. Dr. Czerniak and/or Dr. Tamboli will be consulted in equivocal cases of mixed histology. The Study Chairman is the final arbiter in questions of mixed histology.
- Bi-dimensionally measurable disease. All patients must have measurable or evaluable disease. In general, liver and lung lesions should be at least 1 cm, and patients with node-only disease should have lesions of >/= 1.5 cm in greatest dimension. Patients with disease confined to bone may be eligible if a measurable lytic defect, or soft-tissue component in present. Those without measurable disease may be eligible if a serum marker is elevated (>/= 4 x ULN) (ie: CEA, CA-125, CA19-9, bhCG, etc).
- (# 2 cont'd) The Study Chairman is the final arbiter in questions related to measurability. Patients with a three-dimensional mass or pelvic sidewall fixation on bladder examination under anesthesia are considered to have measurable disease.
- Patients are eligible if they have evidence of metastatic disease, or if their tumor is surgically unresectable. In the absence of grossly metastatic disease, all patients should be seen and evaluated by a member of the Urology staff to assess their potential for resection.
- Patients must have adequate physiologic reserves as evidenced by: • Life expectancy of at least 9 months (based on co-morbidity) \& at least 9 weeks based on the natural history of their cancer. • Zubrod Performance Status (PS) of </= 2; or 3 if of recent onset and due entirely to the cancer and not to comorbidity, and especially if the compromised performance status is due to uncontrolled pain which is expected to be rapidly reversible when therapy starts.
Key exclusion criteria (6 listed)
- Patients with metastases to the bladder from a primary adenocarcinoma arising outside the urinary tract are ineligible.
- Overt psychosis or mental disability or otherwise incompetent to give informed consent.
- A life threatening illness (unrelated to tumor) that would prevent completion of protocol therapy.
- Pregnant or nursing women, as the drug therapy regimen, and support medications pose significant potential risks to the fetus and newborn.
- Patients with second malignancies are eligible provided that the expected outcome from the second cancer is such that this will not interfere in the delivery of this therapy, or the assessment of response.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-Fluorouracil (5-FU)Also: 5-FU, Adrucil, EfudexDay: 1 - 5 Dose: 200 mg/m2 IVCI daily x 5 days | Drug | 5-FU, Leucovorin, Gemcitabine + Cisplatin |
| LeucovorinAlso: Citrovorum, WellcovorinDay: 1 - 5 Dose:10 mg/m2 daily x 5 days | Drug | 5-FU, Leucovorin, Gemcitabine + Cisplatin |
| CisplatinAlso: Platinol-AQ, Platinol, CDDPDay: 1 - 5 Dose: 20 mg/m2 daily x 5 days | Drug | 5-FU, Leucovorin, Gemcitabine + Cisplatin |
| GemcitabineAlso: Gemcitabine Hydrochloride, GemzarDay: 1 \& 5 Dose: 200 mg/m2 (Two doses only) | Drug | 5-FU, Leucovorin, Gemcitabine + Cisplatin |
Primary outcome
Number of Patients with Response
Time frame: Every 2 cycles (6 weeks)
Complete Response: Participants counted as complete response if they have no radiological evidence of tumor, have no signs or symptoms of disease, and have normalized tumor markers (in those with initially elevated markers). Participants with an intact, tumor-containing bladder, must have a cystoscopy and exam under anesthesia to confirm a complete response. Partial response: Any response less than a complete response. Progressive disease: Progressive disease is at least 25% increase in tumor volume, or any new site of involvement, including the CNS. Increasing severity of symptoms, if judged by treating physician to be due to progressive disease, also counted as progression, even if these are not accompanied by an "objective" indicator. Any unequivocal increase (i.e. to greater than 5 mi.u./mL in beta-hCG) in a male patient taken to represent progressive disease, as will two consecutive rises amounting to a total of at least 125% of baseline for any other tumor marker.
1 secondary outcome
Number of Patients with Dose-Limiting Toxicity
Time frame: Continous assessment during 21 day cycles
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- University of Texas MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arlene Siefker-Radtke, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5-Fluorouracil (5-FU), Leucovorin and Cisplatin in people with Bladder Cancer and Urethral Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Response (time frame: Every 2 cycles (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.