Bladder CancerPhase 2NCT00002684
Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer
A Phase 2 study testing cisplatin, ifosfamide and paclitaxel in people with Bladder Cancer and Urethral Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways 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
- What is being tested?
- cisplatin, ifosfamide and paclitaxel
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 1995to Oct 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
DISEASE CHARACTERISTICS:
- Histologically proven unresectable or metastatic urothelial cancer
- No transitional cell histologies
- Bidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Hematopoietic:
- WBC at least 3,500/mm^3
- Platelet count greater than 150,000/mm^3
Hepatic:
- Bilirubin less than 2.0 mg/dL
Renal:
- Creatinine less than 1.5 mg/dL OR
- Creatinine clearance greater than 55 mL/min
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Other:
- No other concurrent malignancy except basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior systemic chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- At least 3 weeks since prior radiotherapy
Surgery
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Phase II Trial of Paclitaxel, Cisplatin and Ifosfamide in Patients With Advanced Urothelial Tumors
RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with metastatic urinary tract cancer that cannot be treated with surgery.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of cisplatin, ifosfamide, and paclitaxel in patients with unresectable or metastatic urothelial cancer (nontransitional cell histologies).
OUTLINE: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-3. Filgrastim (G-CSF) is administered subcutaneously daily beginning on day 6 and continuing through day 17 or until blood counts recover. Treatment continues every 3 weeks for a maximum of 6 courses in the absence of stable or progressive disease after completion of course 2 or complete response after completion of course 4.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
- Conditions
- Bladder Cancer, Urethral Cancer
- Being tested
- cisplatin, ifosfamide, paclitaxel
- Keywords
- stage III bladder cancer, recurrent bladder cancer, stage IV bladder cancer, squamous cell carcinoma of the bladder, adenocarcinoma of the bladder, recurrent urethral cancer, distal urethral cancer, proximal urethral cancer, urethral cancer associated with invasive bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms, Urethral Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
ifosfamideDrug
paclitaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMay 1995
- Primary completionOct 2007
- Study completionOct 2007
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 Memorial Sloan Kettering 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
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Dean F. Bajorin, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002684
- Sponsor's protocol ID
- 95-031
- Other IDs
- CDR0000064373, NCI-V95-0743
- Status last verified
- Jul 2013
- First submitted
- 1 Nov 1999
- Last updated
- 3 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Paclitaxel, Cisplatin and Ifosfamide in Patients With Advanced Urothelial Tumors
- ClinicalTrials.gov ID
- NCT00002684
- Acronym / sponsor ID
- 95-031
- Conditions
- Bladder Cancer, Urethral Cancer
- Keywords
- stage III bladder cancer, recurrent bladder cancer, stage IV bladder cancer, squamous cell carcinoma of the bladder, adenocarcinoma of the bladder, recurrent urethral cancer, distal urethral cancer, proximal urethral cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- May 1995
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 27 Jan 2003 (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 cisplatin, ifosfamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with metastatic urinary tract cancer that cannot be treated with surgery.
Detailed description
OBJECTIVES:
- Determine the efficacy of cisplatin, ifosfamide, and paclitaxel in patients with unresectable or metastatic urothelial cancer (nontransitional cell histologies).
OUTLINE: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-3. Filgrastim (G-CSF) is administered subcutaneously daily beginning on day 6 and continuing through day 17 or until blood counts recover. Treatment continues every 3 weeks for a maximum of 6 courses in the absence of stable or progressive disease after completion of course 2 or complete response after completion of course 4.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| cisplatin | Drug | – |
| ifosfamide | Drug | – |
| paclitaxel | Drug | – |
Primary outcome
Efficacy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
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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.
Dean F. Bajorin, MD study chair
Memorial Sloan Kettering 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 cisplatin, ifosfamide and paclitaxel in people with Bladder Cancer and Urethral Cancer, run by Memorial Sloan Kettering 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?
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: finished, as of the sponsor's last update on 3 Jul 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy. 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 3 Jul 2013.