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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.


Phase 2
18 Years
N/A
Not Enrolling
Both
Renal Cell Cancer

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Czech Republic: State Institute for Drug Control

Study ID:

MO21609

NCT ID:

NCT00796757

Start Date:

December 2008

Completion Date:

February 2012

Related Keywords:

  • Renal Cell Cancer
  • Carcinoma
  • Carcinoma, Renal Cell

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