Recurrent Transitional Cell Cancer of the Renal Pelvis and UreterPhase 2NCT00009867
Arsenic Trioxide in Treating Patients With Urothelial Cancer
A Phase 2 study testing arsenic trioxide in people with Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter and Recurrent Urethral Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent cancer of the bladder or urinary tract. Arsenic trioxide may kill tumor cells that have become resistant to standard chemotherapy regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Urethral Cancer, Transitional Cell Carcinoma of the Bladder
- What is being tested?
- arsenic trioxide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2000to Jun 2004
- 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
Who may be able to join
- Diagnosis of transitional cell carcinoma of the bladder, urethra, ureter or renal pelvis; histologic documentation of metastatic/recurrent disease is not required; clinical staging, but not pathological staging, is required
- Patients must have relapsed from or failed to achieve a complete or partial response after one chemotherapy regimen, which must have included one of the following chemotherapy agents: cisplatin, carboplatin paclitaxel, or gemcitabine
- >= 4 weeks since prior RT or chemotherapy
- Patients must have measurable disease
- CTC (ECOG) Performance Status =< 1
- No evidence of NYHA functional class III or IV heart disease
Show all 12Show fewer
- Baseline EKG with QTc < 500 ms
- Non-pregnant and not nursing, as chemotherapy is thought to present substantial risk to the fetus/infant; men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study
- Granulocytes > 1500/ml
- Platelet count > 100,000/ml
- Bilirubin =< Upper limits of normal (ULN)
- Serum Creatinine < 2.0 x ULN
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer and Leukemia Group B
Chicago, Illinois, 60606
About this study
Official title: A PHASE II STUDY OF ARSENIC TRIOXIDE (NSC #706363, IND #57974) IN UROTHELIAL CANCER
Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent cancer of the bladder or urinary tract. Arsenic trioxide may kill tumor cells that have become resistant to standard chemotherapy regimens.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the efficacy of arsenic trioxide in patients with measurable urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
II. To determine the toxicity of arsenic trioxide administered to patients with urothelial cancer.
OUTLINE:
Patients receive arsenic trioxide IV over 1 hour on days 1-5. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses.
Patients are followed every 2 months for 1 year after registration and then every 6 months for 1 year or until disease progression or relapse.
- Conditions
- Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Urethral Cancer, Transitional Cell Carcinoma of the Bladder, Ureter Cancer
- Being tested
- arsenic trioxide
- Medical subject headings
- Urethral Neoplasms, Ureteral Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arsenic trioxideDrug
Also called Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid Anhydride, AS2O3
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (arsenic trioxide) | Experimental | Patients receive arsenic trioxide IV over 1 hour on days 1-5. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses. Receives: Drug: arsenic trioxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response
95% confidence intervals will be computed using binomial distribution.
Measured: Up to 2 years
Toxicity graded using the CTC
Reported by type, frequency and severity.
Measured: Up to 2 years
Secondary outcomes (2)
Time to disease progression
Estimated using the Kaplan-Meier method.
Measured: From the initiation of treatment to the date of progressive disease, assessed up to 2 years
Duration of objective response
Estimated using the Kaplan-Meier method.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2003 (estimated)
- Study startDec 2000
- Primary completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Transitional Cell Cancer of the Renal Pelvis and UreterStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Dean Bajorin, Principal investigator, Cancer and Leukemia Group B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00009867
- Sponsor's protocol ID
- NCI-2012-02789
- Other IDs
- CALGB-99903, U10CA031946
- Status last verified
- Jun 2013
- First submitted
- 2 Feb 2001
- Last updated
- 4 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE II STUDY OF ARSENIC TRIOXIDE (NSC #706363, IND #57974) IN UROTHELIAL CANCER
- ClinicalTrials.gov ID
- NCT00009867
- Acronym / sponsor ID
- NCI-2012-02789
- Conditions
- Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter, Recurrent Urethral Cancer, Transitional Cell Carcinoma of the Bladder, Ureter Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 2000
- Primary completion
- Jun 2004 (actual)
- First posted
- 31 Dec 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.
Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have recurrent cancer of the bladder or urinary tract. Arsenic trioxide may kill tumor cells that have become resistant to standard chemotherapy regimens.
Detailed description
PRIMARY OBJECTIVES:
- To determine the efficacy of arsenic trioxide in patients with measurable urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis.
II. To determine the toxicity of arsenic trioxide administered to patients with urothelial cancer.
OUTLINE:
Patients receive arsenic trioxide IV over 1 hour on days 1-5. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses.
Patients are followed every 2 months for 1 year after registration and then every 6 months for 1 year or until disease progression or relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (arsenic trioxide) | Experimental | Drug: arsenic trioxidePatients receive arsenic trioxide IV over 1 hour on days 1-5. Treatment repeats every 28 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response receive 2 additional courses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of transitional cell carcinoma of the bladder, urethra, ureter or renal pelvis; histologic documentation of metastatic/recurrent disease is not required; clinical staging, but not pathological staging, is required
- Patients must have relapsed from or failed to achieve a complete or partial response after one chemotherapy regimen, which must have included one of the following chemotherapy agents: cisplatin, carboplatin paclitaxel, or gemcitabine
- >= 4 weeks since prior RT or chemotherapy
- Patients must have measurable disease
- CTC (ECOG) Performance Status =< 1
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| arsenic trioxideAlso: Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid Anhydride, AS2O3Given IV | Drug | Treatment (arsenic trioxide) |
Primary outcome
Objective response
Time frame: Up to 2 years
95% confidence intervals will be computed using binomial distribution.
Toxicity graded using the CTC
Time frame: Up to 2 years
Reported by type, frequency and severity.
2 secondary outcomes
Time to disease progression
Time frame: From the initiation of treatment to the date of progressive disease, assessed up to 2 years
Duration of objective response
Time frame: Up to 2 years
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 4 Jun 2013.
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A Clinical Study of the Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for the Adjuvant Treatment of HER2 Overexpressing UTUC Patients With High Risk Factors for Recurrence After Radical Surgery
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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 Bajorin principal investigator
Cancer and Leukemia Group B
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 arsenic trioxide in people with Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter and Recurrent Urethral Cancer, run by National Cancer Institute (NCI) 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 12 inclusion and 0 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: finished, as of the sponsor's last update on 4 Jun 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?
Objective response (time frame: Up to 2 years). The study lists 2 primary outcomes in all. 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 4 Jun 2013.