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OpenTrials
Completed

NCT Number: NCT00520403

A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.

This single arm study will assess the efficacy and safety of Avastin in combination with interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3 times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3 weeks. The anticipated time on study treatment is until tumor progression, and the target sample size is 100-500 individuals.

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Key information

Conditions

Renal Cell Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients, >=18 years of age;
  • metastatic renal cell cancer of predominantly clear cell type;
  • >=1 measurable lesion.

Exclusion criteria

  • prior treatment with chemotherapy, cytokine or tyrosine kinase inhibitor therapy for metastatic renal cell cancer;
  • ongoing or recent need for full therapeutic dose of anticoagulants or chronic daily treatment with aspirin (>325mg/day);
  • clinically significant cardiovascular disease.

Treatment and study plan

bevacizumab [Avastin]

Drug

15mg/kg iv every 3 weeks

Interferon alfa-2a

Drug

3 MioIU sc escalating to 18 MioIU sc, 3 times weekly

Vinblastine

Drug

0.1mg/kg iv every 3 weeks

Primary outcomes

  1. Percentage of Participants With Disease Progression or Death

    Time frame: Days 0, 91, 182, 273, 365, 456, and 547

    Disease progression was evaluated according to the Response Evaluation Criteria In Solid Tumors (RECIST) using computed tomography (CT) scans (preferred method), magnetic resonance imaging (MRI) scans, X-ray, bone scans, or clinical examination.

  2. PFS - Time to Event

    Time frame: Days 0, 91, 182, 273, 365, 456, and 547

    PFS was defined as the time in days from the date of treatment start to the date of first documented disease progression or death. Disease progression was evaluated according to RECIST using CT scans (preferred method), MRI scans, X-ray, bone scans, or clinical examination. Median PFS was estimated using the Kaplan-Meier method

Secondary outcomes

  1. Percentage of Participants With Objective Response (OR)

    Time frame: Baseline and Cycles 3, 6, 9, 13, and 17

    Percentage of participants with OR based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to RECIST.

  2. Overall Survival (OS)

    Time frame: Baseline, Day 1 of every cycle to disease progression or death (up to Week 102)

    OS was defined as the duration from treatment start to death from any cause. Overall survival was censored at the last contact for surviving participants and missing data points.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open-label Study to Assess the Effect of First-line Treatment With Avastin in Combination With Standard Therapy on Progression-free Survival in Patients With Metastatic Renal Cell Cancer.

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 24, 2007
Registry last updated
Oct 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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