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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00520403

Purpose

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.

Condition	Intervention	Phase
Renal Cell Cancer	Drug: bevacizumab [Avastin] Drug: Interferon alfa-2a Drug: Vinblastine	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Bevacizumab Interferon alfa-n1 Interferon alfa-2a Interferons Vinblastine Vinblastine sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official 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.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Median progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tumor assessment (RECIST criteria) [ Time Frame: Event driven ] [ Designated as safety issue: No ]
AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2013

Arms	Assigned Interventions
1: Experimental	Drug: bevacizumab [Avastin] 15mg/kg iv every 3 weeks Drug: Interferon alfa-2a 3 MioIU sc escalating to 18 MioIU sc, 3 times weekly Drug: Vinblastine 0.1mg/kg iv every 3 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520403

Contacts

Contact: Please reference Study ID Number: ML19983	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Germany
	Active, not recruiting
Leipzig, Germany, 04103
	Active, not recruiting
JENA, Germany, 07743
	Active, not recruiting
BERLIN, Germany, 10117
	Not yet recruiting
GREIFSWALD, Germany, 17489
	Active, not recruiting
KIEL, Germany, 24105
	Recruiting
HANNOVER, Germany, 30449
	Active, not recruiting
KASSEL, Germany, 34125
	Not yet recruiting
MAINZ, Germany, 55131
	Active, not recruiting
FRANKFURT AM MAIN, Germany, 60596
	Not yet recruiting
DARMSTADT, Germany, 64283
	Not yet recruiting
ULM, Germany, 89081
	Recruiting
BERLIN, Germany, 10967
	Active, not recruiting
REHLING, Germany, 86058
	Recruiting
DESSAU, Germany, 06846
	Active, not recruiting
BREMEN, Germany, 28277
	Completed
ERLANGEN, Germany, 91052
	Active, not recruiting
HALLE, Germany, 06097
	Not yet recruiting
DÜSSELDORF, Germany, 40225
	Active, not recruiting
MAGDEBURG, Germany, 39120
	Active, not recruiting
STUTTGART, Germany, 70174
	Not yet recruiting
COTTBUS, Germany, 03048
	Recruiting
WEIDEN, Germany, 92637

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML19983
Study First Received:	August 23, 2007
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00520403
Health Authority:	Germany: Landesamt fur Gesundheit und Soziales Berlin

Study placed in the following topic categories:

Interferon-alpha
Interferons
Disease Progression
Vinblastine
Urogenital Neoplasms
Bevacizumab
Renal cancer
Urologic Neoplasms
Kidney cancer

Carcinoma
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Interferon Alfa-2a
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Antiviral Agents

Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Angiogenesis Modulating Agents
Growth Inhibitors
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009