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Urothelial CancerPhase 2NCT00995488

Trial of Combination ABI-007, Carboplatin, and Gemcitabine for First Line Treatment of Advanced Urothelial Cancer

A Phase 2 study testing ABI-007 (Abraxane®) in people with Urothelial Cancer and Bladder Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin and gemcitabine in the treatment of patients with advanced bladder cancer. Study participants will have been diagnosed with advanced bladder cancer. Cisplatin based chemotherapy in this setting has activity but is not curative. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Cancer, Bladder Cancer
What is being tested?
ABI-007 (Abraxane®)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Oct 2009to Nov 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

  • Male and female patients at least 18 years of age.
  • Histologic or cytologic diagnosis of urothelial carcinoma (transitional cell carcinoma either pure or mixed histology) that is metastatic or locally recurrent or locally advanced and not eligible for higher priority trials.
  • must have measurable disease.
  • Patients must have recovered from any radiation therapy and must not have had more than 25% of the bone marrow irradiated.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (Appendix 1.)
  • Life expectancy of at least 12 weeks.
Show all 16Show fewer
  • Adequate organ and marrow function as defined below obtained within 14 days from registration:
  • absolute neutrophil count >1,500/µL
  • platelets >100,000/µL
  • total bilirubin =1.5 mg/dL
  • creatinine <2.0 mg/dL
  • AST and ALT <2.5 X upper limits of normal
  • Timing guideline for pre-study labs and measurements:
  • All pre-study labs required for determination of eligibility are to be completed within 14 days prior to registration.
  • X-rays and/or scans to assess all disease sites are to be completed within 1 month prior to registration (or the next business day if falls on a weekend or holiday).
  • All patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and federal guidelines.

Who cannot join

  • Previous systemic chemotherapy for the current stage of disease.
  • Prior treatment with ABI-007 or other taxane (prior treatment with taxane in neoadjuvant or adjuvant setting more than one year prior to registration is allowed).
  • Pre-existing neuropathy that is > grade 2 (i.e. interfering with patient function).
  • History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan.
  • Known HIV positive patients may not participate. This is to avoid additional complications that immune suppression and HIV infection may cause due to the intense nature of the chemotherapy in this trial.
  • Concurrent treatment on another therapeutic clinical trial. Supportive care trials or non-treatment trials, e.g. QOL, are allowed.
  • Pregnancy or breastfeeding. Female subjects must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. All female subjects with reproductive potential must have a negative pregnancy test (serum) prior to enrollment. Male subjects must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: ABX209: Phase II Trial of Combination ABI-007, Carboplatin, and Gemcitabine for First Line Treatment of Advanced Urothelial Cancer.

This study will evaluate the safety and efficacy of the combination of ABI-007, carboplatin and gemcitabine in the treatment of patients with advanced bladder cancer.

Study participants will have been diagnosed with advanced bladder cancer. Cisplatin based chemotherapy in this setting has activity but is not curative. Furthermore, patients with this disease have comorbidities that limit the use of cisplatin based therapy. Combination paclitaxel, carboplatin and gemcitabine is active and well tolerated in this patient population.

Paclitaxel is formulated with ethanol and a Cremophor EL (polyoxyethylated castor oil) which contribute to the side effects associated with paclitaxel. ABI-007 (brand name Abraxane™) is a form of paclitaxel that 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 based on superior anticancer effect, and is being evaluated in other cancers in research studies.

Read the detailed description

On the basis of the known single agent activity of paclitaxel in urothelial cancer, the activity of combination therapy with paclitaxel, carboplatin, and gemcitabine in advanced urothelial cancer coupled with the results from studies in breast cancer demonstrating improved clinical efficacy of ABI-007 over paclitaxel with a more favorable toxicity profile, we propose this phase II trial evaluating the efficacy and safety of the combination of ABI-007, carboplatin, and gemcitabine in patients with advanced urothelial cancer.

Carboplatin and gemcitabine dosing and schedule is based on our previous trial of paclitaxel, carboplatin, and gemcitabine which showed acceptable toxicity.

Due to the extent of hematologic toxicities expected with this combination and reported with weekly schedules of ABI-007 based combinations as well as our experience on UMCC protocol 2007.061 which originally utilized a weekly ABI-007 with gemcitabine and carboplatin, we do not feel continuous weekly dosing will be feasible. Therefore this trial is designed with ABI-007 on a D1 only schedule every 21 days. The starting dose of ABI-007 will be 220 mg/m2, because of the risk of significant bone marrow suppression, with the option of a dose escalation in patients who tolerate therapy well after the first cycle to 260 mg/m2 every 21 days.

Being tested
ABI-007 (Abraxane®)
Keywords
Urothelial Cancer, ABI-007, Bladder Cancer, front-line
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-007 (Abraxane®)Drug

    Also called Abraxane, albumin-bound paclitaxel

    ABI-007 is a novel albumin-bound paclitaxel combining a protein with a chemotherapeutic agent in the particle form.

Study groups in NCT00995488
Study groupRoleWhat they receive
ABI-007ExperimentalABI-007 combined with Carboplatin, and Gemcitabine
Receives: Drug: ABI-007 (Abraxane®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With a Partial or Complete Response

    Clinical efficacy of ABI-007 based therapy will be determined by the overall response rate (Partial Response [PR] + Complete Response[CR]) to therapy.

    Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions.

    Complete Response: Disappearance of all target lesions.

    Measured: 2 years

Secondary outcomes (1)

  1. Median Overall Survival

    The Median Overall Survival was captured in months.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionNov 2013
  4. Study completionNov 2013

Why it stopped: Terminated prematurely due to low accrual.

Resources

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00995488
Sponsor's protocol ID
2009.025
Other IDs
HUM00029138
Status last verified
Aug 2015
First submitted
14 Oct 2009
Last updated
11 Sep 2015
Data monitoring committee
Yes

Publications

  • Alva A, Daignault S, Smith DC, Hussain M. Phase II trial of combination nab-paclitaxel, carboplatin and gemcitabine in first line therapy of advanced urothelial carcinoma. Invest New Drugs. 2014 Feb;32(1):188-94. doi: 10.1007/s10637-013-0054-5. Epub 2013 Dec 10.

    PubMed 24318901

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABI-007 (Abraxane®) in people with Urothelial Cancer and 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 16 inclusion and 8 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: stopped early, as of the sponsor's last update on 11 Sep 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 19 Sep 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 Participants With a Partial or Complete Response (time frame: 2 years). 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 NCT00995488, 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 11 Sep 2015.

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