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Bladder CancerPhase 2RAD001NCT00933374

Trial to Evaluate Paclitaxel Plus RAD001 in Urothelial Carcinoma

A Phase 2 study testing paclitaxel and RAD001 in people with Bladder Cancer, run by Heinrich-Heine University, Duesseldorf at 6 sites in Germany.

Terminated

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

Official record
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Trial summary

This is a single arm open- label phase II- trial evaluating safety and efficacy of paclitaxel and RAD001 in patients with metastatic urothelial bladder cancer who failed prior platin-based systemic therapy. 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?
paclitaxel and RAD001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
6 sitesGermany
Study dates
Jul 2009to Sep 2013
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

  • Patients with histologically proven carcinoma of the urinary tract including urinary bladder, ureter, renal pelvis and lower urinary tract. Urothelial carcinoma should be the predominant histology
  • Confirmation of locally relapsed or metastatic disease by imaging. Measurable disease according to RECIST- guidelines with ≥1 measurable lesion has to be evident.
  • If bone is the only metastatic site a quantification of the target lesion(s) using MRI is mandatory.
  • Failure of prior platin- based chemotherapy
  • Patients may have shown progressive disease within the first 3 months of platin-based chemotherapy (primary failure) or progression within 3 months after the end of platin-based chemotherapy (early relapse)-Prior therapy with ≤ 4 chemotherapeutic drugs
  • Patients with tumor relapse within 3 months after cystectomy in the neoadjuvant or adjuvant setting are not eligible.
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  • ECOG performance status 0-2
  • Adequate haematological, liver and renal functions.
  • Neutrophil count > 1500/mm3, haemoglobin > 9 g/dl, platelets ≥ 100.000/ mm3
  • Serum bilirubin ≤ 1.5 x ULN, ALT and AST ≤ 2.5x ULN. Patients with known liver metastases who have an AST and ALT ≤ 5x ULN.
  • serum creatinine ≤ 2 x ULN.
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to the first dose of study drug. Female subjects of childbearing potential must be using two acceptable methods of contraception, from the time of screening and for the duration of the study, through study completion and for 3 months following study completion
  • Age > 18 years.
  • Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.
  • Patients must give written informed consent
  • No concurrent treatment with other experimental drugs or anti-cancer drugs
  • Another distinguishable malignancy will be permitted

Who cannot join

  • chemotherapy, radiation therapy or any other anticancer therapy within 4 weeks of the first dose of study drug.
  • Participation in any clinical investigation within 4 weeks prior to initial dosing.
  • known hypersensitivity to RAD001 or other rapamycin analogs and paclitaxel or other taxanes, or to its excipients.
  • previously received RAD001, other mTOR inhibitors or taxanes or epothilones
  • known metastasis of central nervous system.
  • symptomatic pleural effusions or symptomatic ascites.
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  • wide field radiation therapy to up to ≥ 25% of the bone marrow within 4 weeks prior therapy.
  • intravenous radionuclide therapy, e.g. phosphorus (32P), strontium (89SrCl), rhenium (186Re)or samarium (153Sm).
  • Patients who have undergone major surgery within 4 weeks prior to starting study drug,open biopsy, or significant traumatic injury, or who have not recovered from the side effects of any of the above.
  • Chronic systemic treatment with corticosteroids corresponding to a prednisone equivalent of > 10 mg daily. Patients receiving corticosteroids must be on a stable dose for ≥ 4 weeks prior to the first dose of RAD001. Topical or inhaled corticosteroids are permitted.
  • Concomitant medication with strong CYP3A4- inhibitors or CYP3A4- inducers.
  • active bleeding diathesis.
  • Neuropathy > grade 1.
  • any severe and/or uncontrolled medical conditions(unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤ 6 months, serious uncontrolled cardiac arrhythmia, uncontrolled hyperlipidemia, active or uncontrolled severe infection,cirrhosis,chronic or persistent active hepatitis)
  • severely impaired lung function as defined as spirometry and DLCO that is 50% of the normal predicted value and/or O2 saturation ≤ 88% at rest on room air
  • Uncontrolled diabetes
  • Hepatic impairment with a Child-Pugh score >9

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Heinrich-Heine-University of Duesseldorf, Department of Urology

    Düsseldorf, North Rhine-Westphalia, 40225

  • Universitätsklinik Essen, Klinik für Urologie

    Essen, North Rhine-Westphalia, 45122

  • Universitätsklinik Hamburg, Medizinische Klinik und Poliklinik Onkologie - Hämatologie

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • Klinik für Urologie und Kinderurologie, Universitätsklinikum des Saarlandes

    Homburg, Saarland, 66421

  • Klinik für Urologie, Klinikum rechts der Isar der TU München

    München, Bavaria, 81675

  • Klinik für Urologie, Universitätsklinikum Muenster

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

About this study

Official title: A Single Arm, Multi-center Phase II Trial to Evaluate Paclitaxel Plus RAD001 in Urothelial Carcinoma After Failure of Prior Platin-based Chemotherapy

This is a single arm open- label phase II- trial evaluating safety and efficacy of paclitaxel and RAD001 in patients with metastatic urothelial bladder cancer who failed prior platin-based systemic therapy.

Read the detailed description

The screening phase for checking eligibility and evaluation of the patient prior start of study treatment will last up to 21 days.Tumor histology must be predominant urothelial carcinoma and confirmed histological or cytological.Patients who meet the inclusion criteria will be treated with paclitaxel 175 mg/m2 every 3 weeks and RAD001 10 mg once daily. Each cycle will use the combination of paclitaxel 175 mg/m2 3-weekly with RAD001 10 mg daily starting at day 1 of a 21 days treatment cycle. Additional visits after day 1 are performed at day 8 and day 15 of each cycle Assessment of safety and toxicity will be performed at every visit.

Patients will be treated until no signs of clinical or radiological progression are evident and the study treatment is well tolerated for a maximum of 6 cycles.

Conditions
Bladder Cancer
Being tested
paclitaxel, RAD001
Keywords
bladder cancer, RAD001, Paclitaxel
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.

  • paclitaxelDrug

    Also called Taxol

    Paclitaxel (175 mg/m3)will be administered as a 3 hour continuous IV infusion after standard premedication every 3 weeks

  • RAD001Drug

    Also called Certican, Everolimus

    10 mg RAD001 once daily starting at day 1 of a 21 days treatment cycle

Study groups in NCT00933374
Study groupRoleWhat they receive
Paclitaxel and RAD001Experimental175 mg /m3 paclitaxel every 3 weeks and 10 mg RAD001 once daily starting at day 1 of a 21 days treatment cycle
Receives: Drug: paclitaxel; Drug: RAD001

What is being measured

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

  1. Response rate

    Measured: 3 years

Secondary outcomes (4)

  1. Duration of response

    Measured: from first determination of response until progression

  2. Progression free survival

    Measured: 3 years

  3. overall survival

    Measured: 3 years

  4. safety profile of combination RAD001 and paclitaxel

    Measured: 6 month

Timeline

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

  1. First posted7 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJan 2013
  4. Study completionSep 2013

Why it stopped: delayed recruitment

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
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00933374
Sponsor's protocol ID
CRAD001L DE 17T
Acronym
RAD001
Status last verified
Mar 2015
First submitted
3 Jul 2009
Last updated
18 Mar 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing paclitaxel and RAD001 in people with Bladder Cancer, run by Heinrich-Heine University, Duesseldorf at 6 sites in Germany.

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 17 inclusion and 17 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 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. 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 was stopped early (reason given: delayed recruitment). Results are not available in the source record.

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: 3 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 NCT00933374.

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 18 Mar 2015.

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