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Urothelial CarcinomaPhase 2NCT01600339

A Trial of Cabazitaxel for Advanced Transitional Cell Carcinoma (TCC)

A Phase 2 study testing CABAZITAXEL in people with Urothelial Carcinoma, run by Rambam Health Care Campus at 2 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this phase II multicenter study, the investigators aim to evaluate the efficacy and tolerability of a novel taxane-cabazitaxel as single agent second-line chemotherapy for metastatic urothelial carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Carcinoma
What is being tested?
CABAZITAXEL
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
2 sitesIsrael
Study dates
May 2012to Jan 2015
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

  • Ages eligible for this study are 18 years and older.
  • Histological or cytological diagnosis of urothelial carcinoma. Mixed histologies are permitted as long as transitional cell carcinoma is the major component (i.e. > 50% of the pathologic specimen). Pure or predominant squamous cell carcinomas are not permitted.
  • Patients with transitional cell carcinomas of the renal pelvis and ureter are permitted.
  • Patients must have metastatic or locally advanced unresectable disease.
  • Patients must have received one and only one prior chemotherapeutic regimen which included platinum (at least one cycle) for metastatic/recurrent disease. Neoadjuvant or adjuvant chemotherapy will be considered to have been first line if the patient progressed within 12 months of the last dose.
  • Patients with disease progression more than 12 months following platinum based chemotherapy can be included (rather than platinum re-challenge), according to the investigator's judgment.
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  • ECOG performance status ≤ 2
  • Estimated life expectancy of > 12 weeks.
  • Patients must have measurable disease according to RECIST1.1 criteria.
  • If female of childbearing potential, pregnancy test is negative within 8 days priors to first dose of study drug.
  • If fertile, patient agrees to use an effective method of contraception to avoid pregnancy for the duration of the study.
  • Adequate organ function; Absolute neutrophil count ≥1.5 x 109/L. Platelet count ≥ 100 x109/L. Hemoglobin ≥ 9 g/dL. Total bilirubin ≤1.0x upper limit of normal. AST/SGOT and/or ALT/SGPT ≤ 2.5x upper limit of normal. Calculated creatinine clearance > 40 ml/min (creatinine clearance will be calculated according to CKD-EPI formula: http://www.qxmd.com/calculate-online/nephrology/ckd-epi-egfr).(27)
  • Able to give informed consent.

Who cannot join

  • Prior taxane therapy.
  • Pregnant or lactating females
  • Uncontrolled brain or leptomeningeal involvement (treated brain metastasis permitted if both known lesions and medications e.g. steroids for that indication are stable).
  • History of serious or concurrent illness that might be aggravated by study treatment.
  • Known human immunodeficiency virus (HIV) infection or active hepatitis B/C.
  • History of class II-IV congestive heart failure.
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  • Significant renal impairment.
  • Uncontrolled hematuria.
  • History of severe hypersensitivity reaction (≥grade 3) to docetaxel.
  • History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs.
  • Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix).
  • Other malignancies except adequately controlled basal cell carcinoma of the skin or carcinoma in situ of the cervix or incidental prostate cancer (T1a, Gleason < 7 PSA < 10ng/ml) or any other tumor within 2 years prior to enrollment.
  • Other investigational therapy or radiation therapy within 30 days before registration.
  • Patients not willing to employ adequate contraception for the duration of the study.

Trial locations and contacts

2 sites in 1 country.

Israel2 sites

  • Rambam MC

    Haifa

  • Rabin Medical Center

    Petah Tikva

Other trials in Israel

About this study

Official title: A Single Arm, Multicenter, Open-label Phase II Trial of Cabazitaxel as Second Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Carcinoma

In this phase II multicenter study, the investigators aim to evaluate the efficacy and tolerability of a novel taxane-cabazitaxel as single agent second-line chemotherapy for metastatic urothelial carcinoma.

Read the detailed description

For those patients with advanced bladder cancer who have progressed on a platinum based regimen, no widely accepted standard second line therapy currently exists. Taxanes including paclitaxel and docetaxel have exhibited limited clinical activity in this disease and are sometimes given off study. Cabazitaxel is a novel semi-synthetic taxane with a low affinity for the multidrug resistance 1 protein. In cell lines cabazitaxel is as potent as docetaxel, but in tumor cells that are resistant to taxanes, cabazitaxel overcome taxanes resistance.

In recent clinical data, this drug was shown to have potent activity in patients with metastatic prostate cancer resistant to docetaxel. Based on this phase III data, cabazitaxel was recently approved in the US, Europe and in Israel for these patients. The main toxicity of this taxane is neutropenia and diarrhea, thus primary prevention with GCSF may reduce the main toxicity of this agent.

In this phase II multicenter study, the investigators aim to evaluate the efficacy and tolerability of this novel taxane -cabazitaxel as single agent second-line chemotherapy for metastatic urothelial carcinoma after failure of prior platinum-based chemotherapy.

The patients are planned to receive cabazitaxel at a starting dose of 25 mg/m(2) intravenously over 1 h, following premedication as accepted with cabazitaxel. Treatment cycles are every 3 weeks. All patients will receive primary GCSF support.

Being tested
CABAZITAXEL
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CABAZITAXELDrug

    The patients are planned to receive cabazitaxel at a starting dose of 25 mg/m(2) intravenously over 1 h, following premedication as accepted with cabazitaxel. Treatment cycles are every 3 weeks. All patients will receive primary GCSF support.

Study groups in NCT01600339
Study groupRoleWhat they receive
CABAZITAXELExperimentalcabazitaxel at a starting dose of 25 mg/m
Receives: Drug: CABAZITAXEL

What is being measured

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

  1. Response rate

    The primary end point is objective response rate (ORR): CR+ PR, assessed according to response evaluation criteria in solid tumors (RECIST 1.1) guidelines.

    Measured: up to 2 years

Secondary outcomes (7)

  1. Clinical benefit

    Secondary endpoints include clinical benefit with the following parameters: PR+CR+SD.

    Measured: up to 2 years

  2. Duration of response

    Assessment of duration of response to treatment with Cabazitaxel.

    Measured: up to 2 years

  3. Disease control rate

    Assessment of stable disease ≥ 16 weeks, PR or CR.

    Measured: up to 2 years

  4. PFS

    To determine the progression free survival (PFS) of study population defined as a 20% increase in the largest diameter of the largest lesion by CT scan.

    Measured: up to 2 years

  5. Overall Survival

    To determine the percentage of patients alive at data cutoff from trial entry. Overall survival will be measured from date of randomization to date of death due to any cause.

    Measured: up to 2 years

  6. Safety and tolerability of treatment

    Number of participants with adverse events as a measure of safety and tolerability, assessment of dose modifications according to patient's toxicity levels.

    Measured: up to 2 years

  7. Surrogate markers to cabazitaxel

    Assessment of surrogate markers to cabazitaxel response.

    Measured: up to 3 years

Timeline

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

  1. First posted17 May 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionJan 2015
  4. Study completionJan 2015

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
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01600339
Sponsor's protocol ID
ISGUOG1101.CTIL
Status last verified
May 2015
First submitted
26 Feb 2012
Last updated
12 May 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CABAZITAXEL in people with Urothelial Carcinoma, run by Rambam Health Care Campus at 2 sites in Israel.

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 13 inclusion and 14 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 12 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. 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?

Response rate (time frame: up to 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 NCT01600339.

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 12 May 2015.

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