Bladder CancerPhase 1/2NCT00583349
Intravesicular Abraxane for Treatment-Refractory Bladder Cancer
A Phase 1/2 study testing Abraxane in people with Bladder Cancer, run by Columbia University at 1 site in United States.
Trial summary
Phase I: To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose. To assemble tissue bank to assess molecular correlates for response to intravesical Abraxane therapy. The antibodies analyzed will include p53, p63, Stathmin, Tau and Ki67. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Abraxane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Feb 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must have a diagnosis of transitional cell carcinoma (TCC) of the urinary bladder confirmed at the study institution. The patient must have demonstrated superficial recurrent bladder cancer refractory to standard intravesical therapy. This will include stage Ta, T1, Tis and exclude all patients with muscle invasion (T2). All patients with stage Ta will require documentation of high-grade histology. All grossly visible disease must be fully resected and pathologic stage will be confirmed at the institution where the patient is enrolled. Patients must exhibit disease recurrence after receiving some form of standard intravesical therapy, including Bacillus Calmette-Guerin (BCG), mitomycin, interferon or any combination thereof.
- Age > 18 and must be able to read, understand and sign informed consent
- Performance Status: Eastern Cooperative Oncology Group (ECOG) 0,1 (See Appendix II )
- Peripheral neuropathy: must be < grade 1
- Hematologic-Inclusion within 2 weeks of start of treatment
- Absolute neutrophil count > 1,500/mm3
Show all 16Show fewer
- Hemoglobin >9.0 g/dl
- Platelet count > 100,000/mm3
- Hepatic-Inclusion within 2 weeks of entry
- Total Bilirubin must be within normal limits.
- Adequate renal function with serum creatinine ≤ 2.0 mg/dL
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x upper limit of normal (ULN) for the institution, Alkaline phosphatase ≤ 2.5 x ULN for the institution, unless bone metastasis is present in the absence of liver metastasis
- Women of childbearing potential must have a negative pregnancy test.
- All patients of childbearing potential must be willing to consent to using effective contraception, i.e., intrauterine device (IUD), Birth control pills, Depo-Provera, and condoms while on treatment and for 3 months after their participation in the study ends.
- No intravesical therapy within 6 weeks of study entry
- No prior radiation to the pelvis
Who cannot join
- Prior systemic docetaxel or paclitaxel therapy.
- Any other malignancy diagnosed within 2 years of study entry (except basal or squamous cell skin cancers or non-invasive cancer of the cervix) is excluded.
- Concurrent treatment with any chemotherapeutic agent.
- Women who are pregnant or lactating.
- History of vesicoureteral reflux or an indwelling urinary stent.
- Participation in any other research protocol involving administration of an investigational agent within 3 months prior to study entry aside from the phase I segment of this study.
- History of neuropathy of any cause
Trial locations and contacts
1 site in 1 country.
United States1 site
Herbert Irving Pavillion 11th Floor
New York, New York, 10032
About this study
Official title: A Combined Phase I and Phase II Trial of Intravesical Abraxane, a Biologically Interactive Albumin-bound Paclitaxel, in the Treatment of Refractory Non-muscle Invasive and in T2 Transitional Cell Bladder Cancer
Phase I:
To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose.
To assemble tissue bank to assess molecular correlates for response to intravesical Abraxane therapy. The antibodies analyzed will include p53, p63, Stathmin, Tau and Ki67.
Phase II:
To evaluate the utility (potential for clinical efficacy) of Abraxane in the treatment of refractory non-muscle invasive and a subset of T2 TCC of the bladder as measured by response rate (defined as negative cytology and bladder biopsy).
To further evaluate the safety and toxicity profile of intravesically administered Abraxane therapy.
Read the detailed description
In 2006, it is estimated that 61,420 cases of bladder cancer will be diagnosed in the United States and 13,060 people will die from the disease. This makes bladder cancer the fourth leading cause of cancer in men and the ninth leading cause of cancer in women in the United States. Non-muscle invasive bladder cancer accounts for 70 to 80 percent of these cases and the natural history can vary widely with recurrence being common. In individual cases with high-risk clinical and pathological features (Ta, Tis, and T1) the use of intravesical therapy following complete transurethral resection of the tumor has become the standard of care. However up to 50 percent of patients treated with intravesical therapy for high-risk non-muscle invasive bladder cancer will recur. Response rates to second-line intravesical therapy are 20 percent or less in this population. Innovations in the efficacy of intravesical agents also have applications within a subset of patients with muscle-invasive disease who are undergoing complete transurethral resection in conjunction with local chemotherapy.
- Conditions
- Bladder Cancer
- Being tested
- Abraxane
- Keywords
- Bladder Cancer, Chemotherapy, Bladder Neoplasms
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbraxaneDrug
Also called Paclitaxel protein-bound
Abraxane is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug.
Intravesically administered, dose escalation, 6 weekly instillations
| Study group | Role | What they receive |
|---|---|---|
| Abraxane administration | Experimental | Phase I and Phase II: Patients will receive intravesical Abraxane by sterile urethral catheterization once weekly for six weeks.
Phase II: If a complete response after six weekly installations is achieved, patients will receive additional monthly maintenance instillations until there is a positive cystoscopic biopsy or until a maximum of six additional instillations have been administered. Receives: Drug: Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose (MTD). A DLT is defined by the National Cancer Institute Common Toxicity Criteria version 3.0
Measured: 6 weeks
Number of Participants With Complete Response (CR) or No Response (NR) After Treatment
To evaluate the utility (potential for clinical efficacy) of Abraxane in the treatment of refractory superficial transitional cell carcinomas (TCC) as measured by response rate (defined as negative cytology and bladder biopsy). Patients were considered to have a complete response if they had a negative biopsy and negative cytology. All patients with positive biopsies or cytology were classified as having no response.
Measured: 6 weeks
Secondary outcomes (1)
To Further Evaluate the Safety and Toxicity Profile of Intravesically Administered Abraxane Therapy.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startDec 2008
- Primary completionMar 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- James M McKiernan, MD, Principal investigator, Columbia University Irving Medical Center, Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583349
- Sponsor's protocol ID
- AAAC1114
- Status last verified
- Feb 2025
- First submitted
- 20 Dec 2007
- Last updated
- 17 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Phase I and Phase II Trial of Intravesical Abraxane, a Biologically Interactive Albumin-bound Paclitaxel, in the Treatment of Refractory Non-muscle Invasive and in T2 Transitional Cell Bladder Cancer
- ClinicalTrials.gov ID
- NCT00583349
- Acronym / sponsor ID
- AAAC1114
- Conditions
- Bladder Cancer
- Keywords
- Bladder Cancer, Chemotherapy, Bladder Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Dec 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 31 Dec 2007 (estimated)
- Results
- Posted 17 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I:
To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose.
To assemble tissue bank to assess molecular correlates for response to intravesical Abraxane therapy. The antibodies analyzed will include p53, p63, Stathmin, Tau and Ki67.
Phase II:
To evaluate the utility (potential for clinical efficacy) of Abraxane in the treatment of refractory non-muscle invasive and a subset of T2 TCC of the bladder as measured by response rate (defined as negative cytology and bladder biopsy).
To further evaluate the safety and toxicity profile of intravesically administered Abraxane therapy.
Detailed description
In 2006, it is estimated that 61,420 cases of bladder cancer will be diagnosed in the United States and 13,060 people will die from the disease. This makes bladder cancer the fourth leading cause of cancer in men and the ninth leading cause of cancer in women in the United States. Non-muscle invasive bladder cancer accounts for 70 to 80 percent of these cases and the natural history can vary widely with recurrence being common. In individual cases with high-risk clinical and pathological features (Ta, Tis, and T1) the use of intravesical therapy following complete transurethral resection of the tumor has become the standard of care. However up to 50 percent of patients treated with intravesical therapy for high-risk non-muscle invasive bladder cancer will recur. Response rates to second-line intravesical therapy are 20 percent or less in this population. Innovations in the efficacy of intravesical agents also have applications within a subset of patients with muscle-invasive disease who are undergoing complete transurethral resection in conjunction with local chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abraxane administration | Experimental | Drug: AbraxanePhase I and Phase II: Patients will receive intravesical Abraxane by sterile urethral catheterization once weekly for six weeks. Phase II: If a complete response after six weekly installations is achieved, patients will receive additional monthly maintenance instillations until there is a positive cystoscopic biopsy or until a maximum of six additional instillations have been administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have a diagnosis of transitional cell carcinoma (TCC) of the urinary bladder confirmed at the study institution. The patient must have demonstrated superficial recurrent bladder cancer refractory to standard intravesical therapy. This will include stage Ta, T1, Tis and exclude all patients with muscle invasion (T2). All patients with stage Ta will require documentation of high-grade histology. All grossly visible disease must be fully resected and pathologic stage will be confirmed at the institution where the patient is enrolled. Patients must exhibit disease recurrence after receiving some form of standard intravesical therapy, including Bacillus Calmette-Guerin (BCG), mitomycin, interferon or any combination thereof.
- Age > 18 and must be able to read, understand and sign informed consent
- Performance Status: Eastern Cooperative Oncology Group (ECOG) 0,1 (See Appendix II )
- Peripheral neuropathy: must be < grade 1
- Hematologic-Inclusion within 2 weeks of start of treatment
Key exclusion criteria (7 listed)
- Prior systemic docetaxel or paclitaxel therapy.
- Any other malignancy diagnosed within 2 years of study entry (except basal or squamous cell skin cancers or non-invasive cancer of the cervix) is excluded.
- Concurrent treatment with any chemotherapeutic agent.
- Women who are pregnant or lactating.
- History of vesicoureteral reflux or an indwelling urinary stent.
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 |
|---|---|---|
| AbraxaneAlso: Paclitaxel protein-boundAbraxane is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Intravesically administered, dose escalation, 6 weekly instillations | Drug | Abraxane administration |
Primary outcome
Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Time frame: 6 weeks
To determine the safety, toxicity and efficacy profiles of intravesically administered Abraxane at the Maximum Tolerated Dose (MTD). A DLT is defined by the National Cancer Institute Common Toxicity Criteria version 3.0
Number of Participants With Complete Response (CR) or No Response (NR) After Treatment
Time frame: 6 weeks
To evaluate the utility (potential for clinical efficacy) of Abraxane in the treatment of refractory superficial transitional cell carcinomas (TCC) as measured by response rate (defined as negative cytology and bladder biopsy). Patients were considered to have a complete response if they had a negative biopsy and negative cytology. All patients with positive biopsies or cytology were classified as having no response.
1 secondary outcome
To Further Evaluate the Safety and Toxicity Profile of Intravesically Administered Abraxane Therapy.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
James M McKiernan, MD principal investigator
Columbia University Irving Medical Center, Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Abraxane in people with Bladder Cancer, run by Columbia University 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 16 inclusion and 7 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 17 Feb 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 17 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants Who Experienced a Dose-limiting Toxicity (DLT) (time frame: 6 weeks). 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 17 Feb 2025.