Clinical trial NCT00796757: A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).
Official title: An Open Label Study of the Effect of First Line Treatment With Avastin (Bevacizumab) in Combination With Low-dose Interferon on Progression-free Survival in Patients With Metastatic Clear Cell Renal Cell Carcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Cell Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-11-24
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months
timeFrame: 12 and 24 months
measure: PFS - Percentage of Participants With an Event
timeFrame: Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
measure: PFS - Time to Event
timeFrame: Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
Secondary outcomes:
measure: Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR)
timeFrame: Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
measure: Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months
timeFrame: Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
measure: OS - Percentage of Participants With an Event
timeFrame: Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
measure: OS - Time to Event
timeFrame: Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
measure: Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit
timeFrame: Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT)
measure: EQ-5D - Visual Analog Scale (VAS)
timeFrame: Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and EOT
Other outcomes:
Locations:
city: Olomouc
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Seinäjoki
country: Finland
city: Turku
country: Finland
city: Arnsberg
country: Germany
city: Augsburg
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Freiburg
country: Germany
city: Homburg/Saar
country: Germany
city: Leipzig
country: Germany
city: München
country: Germany
city: Münster
country: Germany
city: Offenburg
country: Germany
city: Planegg
country: Germany
city: Stuttgart
country: Germany
city: Weiden
country: Germany
city: Larissa
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Milano
country: Italy
city: Napoli
country: Italy
city: Pisa
country: Italy
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Amstelveen
country: Netherlands
city: Eindhoven
country: Netherlands
city: Maastricht
country: Netherlands
city: Nijmegen
country: Netherlands
city: Barnaul
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Obninsk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: UFA
country: Russian Federation
city: Ulyanovsk
country: Russian Federation
city: Eskilstuna
country: Sweden
city: Linkoeping
country: Sweden
city: Sundsvall
country: Sweden
city: Vaxjo
country: Sweden
city: Aarau
country: Switzerland
city: Locarno
country: Switzerland
city: Zürich
country: Switzerland
city: Cambridge
country: United Kingdom
city: Cardiff
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.