A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

NCT ID: NCT00796757

Last Updated: 2015-05-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-02-29

Brief Summary

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This single arm study will assess progression free survival, tumor response and safety of Avastin in combination with interferon alfa-2a (IFN) as first line treatment in patients with metastatic clear cell renal cell carcinoma. Patients will receive Avastin (10mg/kg iv) every 2 weeks in combination with a low dose of interferon alfa-2a (3 MIU sc three times per week (t.i.w.). The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Detailed Description

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Conditions

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Renal Cell Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

10mg/kg iv infusion every 2 weeks

interferon alfa-2a

Intervention Type DRUG

3 MIU sc t.i.w.

Interventions

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bevacizumab [Avastin]

10mg/kg iv infusion every 2 weeks

Intervention Type DRUG

interferon alfa-2a

3 MIU sc t.i.w.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* metastatic RCC with majority (\>50%) of conventional clear-cell type;
* prior total nephrectomy for primary RCC;
* at least one measurable or non-measurable lesions;
* ECOG performance score of 0 or 2.

Exclusion Criteria

* prior systemic treatment for metastatic RCC;
* current or previously treated but non-stable CNS metastases or spinal cord compression;
* major surgery (including open biopsy) or radiation therapy within 28 days prior to enrollment;
* significant cardiovascular disease within 6 months prior to enrollment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Olomouc, , Czechia

Site Status

Prague, , Czechia

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Tallinn, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Seinäjoki, , Finland

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Turku, , Finland

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Arnsberg, , Germany

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Augsburg, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Freiburg im Breisgau, , Germany

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Homburg/Saar, , Germany

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Leipzig, , Germany

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München, , Germany

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Münster, , Germany

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Offenburg, , Germany

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Planegg, , Germany

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Stuttgart, , Germany

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Weiden, , Germany

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Larissa, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Milan, , Italy

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Napoli, , Italy

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Pisa, , Italy

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Kaunas, , Lithuania

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Vilnius, , Lithuania

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Amstelveen, , Netherlands

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Eindhoven, , Netherlands

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Maastricht, , Netherlands

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Nijmegen, , Netherlands

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Barnaul, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Obninsk, , Russia

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Saint Petersburg, , Russia

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Ufa, , Russia

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Ulyanovsk, , Russia

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Yekaterinburg, , Russia

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Eskilstuna, , Sweden

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Linköping, , Sweden

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Sundsvall, , Sweden

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Vaxjo, , Sweden

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Aarau, , Switzerland

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Locarno, , Switzerland

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Zurich, , Switzerland

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Cambridge, , United Kingdom

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Cardiff, , United Kingdom

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Countries

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Czechia Estonia Finland Germany Greece Italy Lithuania Netherlands Russia Sweden Switzerland United Kingdom

References

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Melichar B, Bracarda S, Matveev V, Alekseev B, Ivanov S, Zyryanov A, Janciauskiene R, Fernebro E, Mulders P, Osborne S, Jethwa S, Mickisch G, Gore M, van Moorselaar RJ, Staehler M, Magne N, Bellmunt J; BEVLiN Investigators. A multinational phase II trial of bevacizumab with low-dose interferon-alpha2a as first-line treatment of metastatic renal cell carcinoma: BEVLiN. Ann Oncol. 2013 Sep;24(9):2396-402. doi: 10.1093/annonc/mdt228. Epub 2013 Jun 26.

Reference Type DERIVED
PMID: 23803225 (View on PubMed)

Other Identifiers

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2007-006611-23

Identifier Type: -

Identifier Source: secondary_id

MO21609

Identifier Type: -

Identifier Source: org_study_id

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