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BAY 43-9006 (Sorafenib) and Bevacizumab (Avastin) To Treat Solid Tumors

NCT00095459 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2019-12-17

No results posted yet for this study

Summary

Background:

* BAY 43-9006 is an inhibitor of wild-type and mutant B-Raf and c-Raf kinase isoforms in vitro, but it also inhibits p38, c-kit, VEGFR-2 and PDGFR-Beta affecting tumor growth as well as possibly promoting apoptosis by events downstream of c-Raf.
* Bevacizumab is a humanized IgG1 monoclonal antibody (MAb) that binds all biologically active isoforms of human vascular endothelial growth factor (VEGF, or VEGF-A) with high affinity (k(d)= 1.1nM)
* The most common adverse events associated with bevacizumab of any severity include asthenia, pain, headache, hypertension, diarrhea, stomatitis, constipation, epistaxis, dyspnea, dermatitis and proteinuria.
* This Phase I trial is open to patients with all solid tumors.

Objectives:

* Determine the safety and toxicity of the combination of BAY 43-9006 (Sorafenib) and bevacizumab.
* Determine estimates of biochemical changes in the Ras-Raf-MAPK and VEGF signal transduction pathways in tumor and stromal cells in response to treatment at the MTD, at least in a pilot fashion, if those changes are statistically significant.

Eligibility:

* Adults with histologically documented solid tumor malignancy that is metastatic or unresectable and for which standard curative therapies do not exist or are no longer effective.
* Patients must be off prior chemotherapy, radiation therapy, hormonal therapy, or biological therapy for at least 4 weeks.
* All patients enrolling in cohort 2 must have at least one lesion amenable to biopsy.
* ECOG performance status 0 or 1 and adequate organ and marrow function.

Design:

* Cohort I will receive BAY 43-9006 and bevacizumab together at the start of study in a dose escalation fashion.
* Cohort II will be randomized as to which agent they receive for cycle one. Cycles 2 and beyond are treated using both agents.
* Tumor biopsies will be obtained from patients in Cohort II before treatment, two weeks into mono-therapy, and two weeks into combinatorial therapy.
* DCE-MRI studies will be obtained on patients in Cohort II before treatment, two weeks into monotherapy, four weeks into monotherapy, and two weeks into combinatorial therapy.
* FDG-PET studies will be obtained on patients in Cohort II before treatment, two weeks into mono-therapy, and two weeks into combinatorial therapy.
* Patients will be evaluated for toxicity in clinic every 2 weeks for Cycles 1 and 2, and then every 4 weeks.
* Patients will be evaluated for response every 8 weeks using the RECIST criteria.
* Approximately 62 patients will be needed to achieve the objectives of the trial.

Conditions

  • Neoplasms

Interventions

DRUG

Bevacizumab

DRUG

BAY 43-9006

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Elise C Kohn, M.D. · National Cancer Institute (NCI)

Study Design

Purpose
TREATMENT

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-02
Primary Completion
2005-11-01
Completion
2012-07-20

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00095459 on ClinicalTrials.gov