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Kidney CancerPhase 2NCT01264341

Efficacy and Safety of Bevacizumab/Temsirolimus Combination to Treat Advanced Renal Cell Carcinoma

A Phase 2 study testing Bevacizumab and Temsirolimus in people with Kidney Cancer, run by Hellenic Cooperative Oncology Group at 8 sites in Greece.

Terminated

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

Official record
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Trial summary

The purpose of this study is to determine whether the combination of bevacizumab/temsirolimus is effective in patients with advanced renal carcinoma progressing after anti-VEGF treatment Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Cancer
What is being tested?
Bevacizumab and Temsirolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
8 sitesGreece
Study dates
Dec 2010to Jul 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

  • Adult patients (18th year of age completed)
  • Signed and dated written informed consent form prior to any procedures related to this protocol.
  • Histologically confirmed advanced clear cell renal cancer.
  • Measurable disease.
  • Failure of first line anti-VEGF treatment.
  • Performance status 0-2, according to Eastern Cooperative Oncology Group (ECOG) .
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  • Satisfactory hematological parameters:
  • White blood cell count > 4000 mm3.
  • Platelet count 100000/mm3.
  • Neutrophil blood cell count > 1200/ mm3 .
  • Hemoglobin > 9,0 g/dL (can be achieved with red blood cell transfusion).
  • Satisfactory biochemical parameters:
  • Serum creatinine < 2 x Upper Limit of Normal(ULN)
  • Aspartate Aminotransferase (AST)<2,5 x ULN
  • Alanine Transaminase (ALT)< 2,5 x ULN.
  • Bilirubin <2 x ULN
  • (For female patients) Absence of pregnancy (negative pregnancy test for women of reproductive age before enrollment).
  • (For female patients) Non-lactating women.
  • Use of efficient contraceptive measures (women and men) to prevent possible pregnancy of female patient or female partner of a male patient during treatment and until 6 months after the end of treatment.

Who cannot join

  • Prior treatment with mTOR inhibitor.
  • Major surgery (including open biopsy) or insufficient recovery or existence of major trauma within 4 weeks before enrollment.
  • Uncontrolled hypertension.
  • Active infection requiring systemic treatment within 4 weeks prior to enrollment.
  • Minor surgery (for instance, catheter placement) within 2 days before enrollment.
  • Scheduled major surgery within the treatment period.
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  • Medical history in the last 6 months prior to enrollment of significant cardiovascular disease, diabetes, cardiac infarction, unstable angina, uncontrolled arrhythmia or significant heart failure.
  • Indications of uncontrolled metastases or disease progression in CNS lesions (the suspicion of uncontrolled metastases or disease progression should be eliminated by imaging techniques within 14 days prior to enrollment).
  • Medical history in the last 5 years prior to enrollment of any other malignancies (excluding the basal or squamous skin cell carcinoma or in situ carcinoma of the cervix).
  • History of non-healing wound including active gastric ulcer.
  • History of fistula in the last 6 months prior to enrollment.
  • History of gastrointestinal perforations.
  • Patient incapacity (for psychiatric or social reasons) to conform with the protocol.
  • History of hemorrhagic predisposition.
  • History of hypersensitivity to the medications under investigation.
  • Significant proteinurea.
  • Prior immunotherapy within 4 weeks prior to enrollment.
  • Prior radiation treatment within 2 weeks prior to enrollment.
  • Concomitant medication with inducers or strong inhibitors of the coenzyme CYP3A4 (see Appendix 5 for an indicative list of active compounds).
  • Concurrent participation in other interventional clinical trials with investigational medicinal products.
  • History of chronic interstitial lung disease.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Greece8 sites

  • General Peripheral Hospital of Athens "Alexandra"

    Athens, Athens, 11528

  • General Hospital of Athens "Hippokratio"

    Athens, 11527

  • Agii Anargiri Cancer Hospital, 2nd Dept of Medical Oncology

    Athens, 14564

  • Agii Anargiri Cancer Hospital, 3rd Dept of Medical Oncology

    Athens, 14564

  • Metropolitan Hospital, 1st Dept of Medical Oncology

    Athens, 18547

  • Metropolitan Hospital, 2nd Dept of Medical Oncology

    Athens, 18547

  • University Hospital of Patras

    Rio, Patras, 26500

  • Papageorgiou General Hospital

    Thessaloniki, 56429

Other trials in Greece

About this study

Official title: Phase II Study of Efficacy and Safety of Bevacizumab in Combination With Temsirolimus, After 1st Line Anti-VEGF Treatment in Patients With Advanced Renal Cancer

The purpose of this study is to determine whether the combination of bevacizumab/temsirolimus is effective in patients with advanced renal carcinoma progressing after anti-VEGF treatment

Conditions
Kidney Cancer
Being tested
Bevacizumab, Temsirolimus
Medical subject headings
Kidney Neoplasms

What participants receive

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

  • BevacizumabDrug

    Bevacizumab 10mg/kg intravenous every 2 weeks until disease progression, unacceptable toxicity or consent withdrawal.

  • TemsirolimusDrug

    Temsirolimus 25mg intravenous once weekly until disease progression, unacceptable toxicity or consent withdrawal.

Study groups in NCT01264341
Study groupRoleWhat they receive
Bevacizumab combined with temsirolimusExperimentalBevacizumab 10mg/kg intravenous every 2 weeks Temsirolimus 25mg intravenous once weekly
Receives: Drug: Bevacizumab; Drug: Temsirolimus

What is being measured

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

  1. 6-month Progression Free Survival (PFS)

    Proportion of patients who are progression-free at 6month evaluation from treatment initiation

    Measured: 32 months

Secondary outcomes (7)

  1. Progression Free Survival (PFS)

    PFS will be calculated from date of treatment initiation until disease progression or death (whichever occurs first)

    Measured: Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks

  2. Overall Survival (OS)

    OS will be calculated from the date of treatment initiation to the date of death or last contact

    Measured: 48 months

  3. Response Rate (RR)

    RR is defined as the overall percentage of patients with partial (PR) or complete response (CR). The evaluation of responses will be performed according to RECIST criteria

    Measured: Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks

  4. Tumor Shrinkage

    Tumor shrinkage will be computed using waterfall plots

    Measured: Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks

  5. Adverse Events (AEs) of all participants will be recorded and assessed upon signature of the informed consent form, until 30 days after the last administration of study treatment.

    Adverse Events will be graded according to the NCI CTCAE v3.0 criteria and will be reported in a frequency table according to the highest severity grade observed per patient

    Measured: 3 years

  6. Quality of Life (QoL) assessment

    QoL will be assessed using the EORTC QLQ C-30 questionnaire. The change in the QoL during treatment will be estimated using the Wilcoxon paired t-test

    Measured: At baseline and every 8 weeks during treatment

  7. Investigation of antiangiogenic factors (FGF, VEGF, VEGFRR)

    Changes in serum levels of antiangiogenic factors during treatment and correlation to the outcome of study treatment.

    Measured: 36 months

Timeline

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

  1. First posted21 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionJul 2015
  4. Study completionJul 2015

Why it stopped: Based on the developments in the treatment of recurrent metastatic renal cancer, the study treatment is no longer considered to be the best treatment option

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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01264341
Sponsor's protocol ID
HE 21/10
Other IDs
2010-020664-38
Status last verified
Feb 2017
First submitted
20 Dec 2010
Last updated
14 Feb 2017
Results posted
No
Data monitoring committee
No

Publications

  • Bamias A, Karavasilis V, Gavalas N, Tzannis K, Samantas E, Aravantinos G, Koutras A, Gkerzelis I, Kostouros E, Koutsoukos K, Zagouri F, Fountzilas G, Dimopoulos MA. The combination of bevacizumab/temsirolimus after first-line anti-VEGF therapy in advanced renal-cell carcinoma: a clinical and biomarker study. Int J Clin Oncol. 2019 Apr;24(4):411-419. doi: 10.1007/s10147-018-1361-9. Epub 2018 Oct 29.

    PubMed 30374686

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab and Temsirolimus in people with Kidney Cancer, run by Hellenic Cooperative Oncology Group at 8 sites in Greece.

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 19 inclusion and 21 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 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Greece. 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: Based on the developments in the treatment of recurrent metastatic renal cancer, the study treatment is no longer considered to be the best treatment option). 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?

6-month Progression Free Survival (PFS) (time frame: 32 months). 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 NCT01264341, 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 14 Feb 2017.

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