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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00387751
Other study ID # NCI-2009-00134
Secondary ID NCI-2009-00134CD
Status Completed
Phase Phase 2
First received October 12, 2006
Last updated October 19, 2017
Start date August 2006
Est. completion date January 2010

Study information

Verified date October 2017
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial is studying how well giving bevacizumab together with sorafenib works in treating patients with unresectable stage III or stage IV malignant melanoma. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of melanoma by blocking blood flow to the tumor. Giving bevacizumab together with sorafenib may kill more tumor cells.


Description:

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Study Design


Intervention

Biological:
Bevacizumab
Given IV
Other:
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Drug:
Sorafenib Tosylate
Given orally

Locations

Country Name City State
United States Cancer Therapy and Research Center at The UT Health Science Center at San Antonio San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response Clinical biologic activity of treatment, defined as the sum of complete response, partial response, and prolonged stable disease for = 16 weeks, upon treatment with the combination of sorafenib and bevacizumab, in patients with advanced metastatic melanoma previously treated with immunotherapy or in previously untreated patients who are not appropriate candidates to receive IL-2-based treatment.
Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started of the appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
4 months
Secondary Safety and Tolerability Safety and tolerability of treatment, in terms of toxicity profile and incidence and rating of toxicity, according to NCI CTCAE v3.0 criteria. 6 months
Secondary Survival Determined by time to progression, progression-free suvival, and overall survival. 6 months
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