Bladder CancerPhase 2NCT00585689
Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Locally Advanced Bladder Cancer
A Phase 2 study testing ABI-007, Carboplatin and Gemcitabine in people with Bladder Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
Study participants will have been diagnosed with bladder cancer that has invaded the muscle wall of the bladder. Surgery is used to remove cancer when it is in the muscle of the bladder. Unfortunately, approximately 50% of people may have their cancer return in another location. 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?
- ABI-007, Carboplatin and Gemcitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Apr 2013
- Phase
- Phase 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
- Histologically proven locally advanced (T2-4,N0,M0 or Tany,N1-3,M0) urothelial carcinoma of the bladder and be candidates for cystectomy following chemotherapy. Tumor specimens must be available for assay of molecular markers (correlative research).
- Performance status of 0, 1 or 2 by Eastern Cooperative Oncology Group (ECOG) criteria.
- Serum creatinine <2.0 mg/dl and/or creatinine clearance >40 ml/min.
- Granulocyte count > 1,500/mm3, platelet > 100,000/mm3, and hemoglobin > 9.0 g/dl.
- Adequate liver functions: AST and ALT < 2.5 X upper limit of normal, alkaline phosphatase < 2.5 X upper limit of normal, and bilirubin < 1.5 mg/dl.
- Pre-existing peripheral neuropathy > grade 2
- Recovered from any effects of surgery.
- Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Women with reproductive potential must have a negative pregnancy test.
Who cannot join
- Prior systemic or intra-arterial chemotherapy and rior radiotherapy. (intravesical chemotherapy allowed.)
- Pre-existing peripheral neuropathy > grade 2
- Prior malignancy [except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for 2 years]
- Unresolved bacterial infection requiring active treatment with antibiotics. (Treatment may begin at the conclusion of antibiotic therapy.)
- Pregnant or lactating women may not participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Two Trial of Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Patients With Locally Advanced Carcinoma of the Bladder
Study participants will have been diagnosed with bladder cancer that has invaded the muscle wall of the bladder. Surgery is used to remove cancer when it is in the muscle of the bladder. Unfortunately, approximately 50% of people may have their cancer return in another location. For this reason, researchers are focusing on new chemotherapy regimens to be given before surgery (to remove the bladder) that may decrease the likelihood of cancer spreading.
Paclitaxel, carboplatin and gemcitabine are chemotherapy drugs known to destroy bladder cancer cells.
Read more
ABI-007 (brand name Abraxane™) is a form of the chemotherapy drug called paclitaxel. Standard paclitaxel is formulated with ethanol and a substance called Cremophor EL (polyoxyethylated castor oil). However, these additives are felt to contribute to the side effects (possibly severe) associated with paclitaxel. ABI-007 does not contain these additives and may deliver more drug to tumor cells. ABI-007 is approved by the United States Food and Drug Administration (FDA) in the treatment of metastatic (advanced) breast cancer, and is being evaluated in other cancers in research studies.
This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin and gemcitabine in the treatment of bladder cancer prior to surgery to remove the bladder.
- Conditions
- Bladder Cancer
- Being tested
- ABI-007, Carboplatin, Gemcitabine, Radical Cystectomy
- Keywords
- Locally advanced urothelial carcinoma of the bladder
- 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.
ABI-007Drug
ABI-007 will be administered at a dose of 260 mg/m2 over a 30 min IV infusion on day 1 of each 21 day cycle.
CarboplatinDrug
Carboplatin will be administered at a dose of TARGET AUC=5 over a 15 min IV infusion of day 1 of each 21 day cycle.
GemcitabineDrug
Gemcitabine will be administered at a dose of 800 mg/m2 over a 30 min IV infusion on days 1 and 8 of each 21 day cycle.
Radical CystectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant ABI-007, Carboplatin, and Gemcitabine | Experimental | Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days. Receives: Drug: ABI-007; Drug: Carboplatin; Drug: Gemcitabine; Procedure: Radical Cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Complete Pathologic Response After 3 Cycles of Treatment
The rate of pathologic complete response (pT0) following three 21 day cycles of neoadjuvant ABI-007, carboplatin and gemcitabine was determined.
Measured: 63 days (post 3 cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionApr 2013
- Study completionApr 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- David C Smith, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585689
- Sponsor's protocol ID
- UMCC 2007.061
- Other IDs
- HUM 13486
- Status last verified
- Nov 2015
- First submitted
- 26 Dec 2007
- Last updated
- 30 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Grivas PD, Hussain M, Hafez K, Daignault-Newton S, Wood D, Lee CT, Weizer A, Montie JE, Hollenbeck B, Montgomery JS, Alva A, Smith DC. A phase II trial of neoadjuvant nab-paclitaxel, carboplatin, and gemcitabine (ACaG) in patients with locally advanced carcinoma of the bladder. Urology. 2013 Jul;82(1):111-7. doi: 10.1016/j.urology.2013.03.044. Epub 2013 May 21.
PubMed 23706253
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Two Trial of Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Patients With Locally Advanced Carcinoma of the Bladder
- ClinicalTrials.gov ID
- NCT00585689
- Acronym / sponsor ID
- UMCC 2007.061
- Conditions
- Bladder Cancer
- Keywords
- Locally advanced urothelial carcinoma of the bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Dec 2007
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Jan 2008 (estimated)
- Results
- Posted 5 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study participants will have been diagnosed with bladder cancer that has invaded the muscle wall of the bladder. Surgery is used to remove cancer when it is in the muscle of the bladder. Unfortunately, approximately 50% of people may have their cancer return in another location. For this reason, researchers are focusing on new chemotherapy regimens to be given before surgery (to remove the bladder) that may decrease the likelihood of cancer spreading.
Paclitaxel, carboplatin and gemcitabine are chemotherapy drugs known to destroy bladder cancer cells.
ABI-007 (brand name Abraxane™) is a form of the chemotherapy drug called paclitaxel. Standard paclitaxel is formulated with ethanol and a substance called Cremophor EL (polyoxyethylated castor oil). However, these additives are felt to contribute to the side effects (possibly severe) associated with paclitaxel. ABI-007 does not contain these additives and may deliver more drug to tumor cells. ABI-007 is approved by the United States Food and Drug Administration (FDA) in the treatment of metastatic (advanced) breast cancer, and is being evaluated in other cancers in research studies.
This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin and gemcitabine in the treatment of bladder cancer prior to surgery to remove the bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant ABI-007, Carboplatin, and Gemcitabine | Experimental | Drug: ABI-007, Drug: Carboplatin, Drug: Gemcitabine, Procedure: Radical CystectomyNeoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically proven locally advanced (T2-4,N0,M0 or Tany,N1-3,M0) urothelial carcinoma of the bladder and be candidates for cystectomy following chemotherapy. Tumor specimens must be available for assay of molecular markers (correlative research).
- Performance status of 0, 1 or 2 by Eastern Cooperative Oncology Group (ECOG) criteria.
- Serum creatinine <2.0 mg/dl and/or creatinine clearance >40 ml/min.
- Granulocyte count > 1,500/mm3, platelet > 100,000/mm3, and hemoglobin > 9.0 g/dl.
- Adequate liver functions: AST and ALT < 2.5 X upper limit of normal, alkaline phosphatase < 2.5 X upper limit of normal, and bilirubin < 1.5 mg/dl.
Key exclusion criteria (5 listed)
- Prior systemic or intra-arterial chemotherapy and rior radiotherapy. (intravesical chemotherapy allowed.)
- Pre-existing peripheral neuropathy > grade 2
- Prior malignancy [except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for 2 years]
- Unresolved bacterial infection requiring active treatment with antibiotics. (Treatment may begin at the conclusion of antibiotic therapy.)
- Pregnant or lactating women may not participate.
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 |
|---|---|---|
| ABI-007ABI-007 will be administered at a dose of 260 mg/m2 over a 30 min IV infusion on day 1 of each 21 day cycle. | Drug | Neoadjuvant ABI-007, Carboplatin, and Gemcitabine |
| CarboplatinCarboplatin will be administered at a dose of TARGET AUC=5 over a 15 min IV infusion of day 1 of each 21 day cycle. | Drug | Neoadjuvant ABI-007, Carboplatin, and Gemcitabine |
| GemcitabineGemcitabine will be administered at a dose of 800 mg/m2 over a 30 min IV infusion on days 1 and 8 of each 21 day cycle. | Drug | Neoadjuvant ABI-007, Carboplatin, and Gemcitabine |
| Radical Cystectomy | Procedure or surgery | Neoadjuvant ABI-007, Carboplatin, and Gemcitabine |
Primary outcome
Percentage of Patients With Complete Pathologic Response After 3 Cycles of Treatment
Time frame: 63 days (post 3 cycles)
The rate of pathologic complete response (pT0) following three 21 day cycles of neoadjuvant ABI-007, carboplatin and gemcitabine was determined.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23706253Grivas PD, Hussain M, Hafez K, Daignault-Newton S, Wood D, Lee CT, Weizer A, Montie JE, Hollenbeck B, Montgomery JS, Alva A, Smith DC. A phase II trial of neoadjuvant nab-paclitaxel, carboplatin, and gemcitabine (ACaG) in patients with locally advanced carcinoma of the bladder. Urology. 2013 Jul;82(1):111-7. doi: 10.1016/j.urology.2013.03.044. Epub 2013 May 21.
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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.
David C Smith, MD principal investigator
University of Michigan
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 ABI-007, Carboplatin and Gemcitabine in people with Bladder Cancer, run by University of Michigan Rogel 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 8 inclusion and 5 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 30 Nov 2015. 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?
Yes. Results are posted in the registry (first posted 5 Jun 2014). 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?
Percentage of Patients With Complete Pathologic Response After 3 Cycles of Treatment (time frame: 63 days (post 3 cycles)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00585689, which also lists 1 linked publication.
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 30 Nov 2015.