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Clear Cell Renal Cell CarcinomaPhase 1/2NCT00193258

Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma

A Phase 1/2 study testing Bevacizumab, Erlotinib and Imatinib in people with Clear Cell Renal Cell Carcinoma, run by SCRI Development Innovations, LLC.

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

This phase I/II trial will evaluate the bevacizumab/erlotinib combination with the addition of imatinib (Gleevec). The combined inhibition greatly enhances the anti-tumor effects. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Clear Cell Renal Cell Carcinoma
What is being tested?
Bevacizumab, Erlotinib and Imatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
No sites listed yet
Study dates
Jun 2004to Aug 2011
Phase
Phase 1/2
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

  • To be included in this study, you must meet the following criteria:
  • Metastatic or unresectable clear cell renal carcinoma confirmed by biopsy
  • Previous nephrectomy is required
  • Maximum of 1 previous systemic regimen for metastatic disease.
  • Able to perform activities of daily living with minimal assistance
  • Measurable disease
  • Adequate bone marrow, liver and kidney
  • Written informed consent.

Who cannot join

  • Age < 18 years
  • Treatment with more than 1 previous systemic regimen
  • History of heart attack within 6 months
  • Clinically significant cardiovascular disease
  • Moderate to severe vascular disease.
  • Active brain metastases.
Show all 22Show fewer
  • History or evidence by physical examination of brain tumor
  • Seizures not controlled with standard medical therapy
  • history of stroke or other serious disorders of the nervous system
  • Clinical history of coughing or vomiting blood within the past 3 months.
  • PEG tubes or G tubes
  • Chronic therapy with NSAIDS or other platelet inhibitors
  • Proteinuria
  • Nonhealing wound, ulcer, or long bone fracture
  • Clinical evidence or history of a bleeding disorder
  • Requiring full dose anticoagulation with coumadin
  • Receiving chronic steroid therapy
  • Significant medical conditions.
  • Tumors other than clear cell
  • History of stroke within 6 months.
  • History of abdominal fistula,perforation,or abscess within 6 months.
  • Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

About this study

Official title: A Phase I/II Trial of Bevacizumab (Avastin), Erlotinib (Tarceva), and Imatinib (Gleevec) in the Treatment of Patients With Advanced Renal Cell Carcinoma

This phase I/II trial will evaluate the bevacizumab/erlotinib combination with the addition of imatinib (Gleevec). The combined inhibition greatly enhances the anti-tumor effects. Although the safety of the bevacizumab/erlotinib/imatinib combination has not yet been demonstrated, the mild to moderate side effects of all of these agents are not predicted to cause prohibitive toxicity. A brief phase I portion will be included in this trial, to optimize doses of the 3 agents prior to proceeding with the phase II trial.

Read the detailed description

Upon determination of eligibility, patients will be receive:

Bevacizumab + Erlotinib + Imatinib

A brief phase I dose escalation study will be performed to define the imatinib dose that will be used.

Being tested
Bevacizumab, Erlotinib, Imatinib
Keywords
Recurrent clear cell renal cell carcinoma, Bevacizumab, Erlotinib, Imatinib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

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

  • BevacizumabDrug

    Also called Avastin

    10mg/kg IV infusion every 2 weeks

  • ErlotinibDrug

    Also called Tarceva

    150 mg po daily

  • ImatinibDrug

    Also called STI571, Gleevec, Glivec, imatinib mesilate (INN)

    400-600mg daily

Study groups in NCT00193258
Study groupRoleWhat they receive
InterventionExperimentalIn the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
Receives: Drug: Bevacizumab; Drug: Erlotinib; Drug: Imatinib

What is being measured

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

  1. Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: 18 months

  2. Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease

    Measured: 18 months

  3. Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

    Measured: 24 months

Timeline

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

  1. First posted19 Sep 2005 (estimated)
  2. Study startJun 2004
  3. Primary completionJan 2011
  4. Study completionAug 2011

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00193258
Sponsor's protocol ID
SCRI GU 22
Status last verified
Jan 2013
First submitted
12 Sep 2005
Last updated
31 Jan 2013
Data monitoring committee
No

Publications

  • Hainsworth JD, Spigel DR, Sosman JA, Burris HA 3rd, Farley C, Cucullu H, Yost K, Hart LL, Sylvester L, Waterhouse DM, Greco FA. Treatment of advanced renal cell carcinoma with the combination bevacizumab/erlotinib/imatinib: a phase I/II trial. Clin Genitourin Cancer. 2007 Dec;5(7):427-32. doi: 10.3816/CGC.2007.n.030.

    PubMed 18272024

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Bevacizumab, Erlotinib and Imatinib in people with Clear Cell Renal Cell Carcinoma, run by SCRI Development Innovations, LLC.

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 22 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 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 14 Jan 2013). 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?

Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment (time frame: 18 months). The study lists 3 primary outcomes in all. 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 NCT00193258, 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 31 Jan 2013.

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