Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00139360|
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : August 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Drug: Bevacizumab||Phase 2|
In Norway, cutaneous malignant melanoma is the second most frequent and the most frequent cancer type in middle-aged (30-54 years) females and males, respectively, and the incidence has six-doubled during the last 30 years. Median survival for patients with metastatic melanoma is 6 months.
Many agents have been investigated for anti-tumor effect in melanoma, but there is no accepted standard therapy. Biochemotherapy, combining cytotoxic drugs with Interleukin-2 or Interferon alpha, has not been shown to be superior to single agent Dacarbazine (DTIC), which is regarded to be the most active agent. Other biological approaches like vaccination are currently under investigation, but still no efficient treatment for metastatic melanoma is available. DTIC induces objective remission in 20% of the patients, but without significant impact on survival.
The need of a new and effective treatment for the group of melanoma patients is urgently needed. This will be the first study to assess response rates of bevacizumab monotherapy in first line treatment of metastatic melanoma. In addition there will be a major focus on the identification of predictive biomarkers of bevacizumab efficacy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Bevacizumab Monotherapy in Treatment of Metastatic Melanoma and Predictive Value of Angiogenic Markers|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Anti angiogenesis treatment
- Clinical Response rates [ Time Frame: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years. ]
- Time to progression [ Time Frame: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years. ]
- Overall survival [ Time Frame: Evaluated by CT scans every 12 weeks, later every 6 monts. Up to 10 years. ]
- Safety data [ Time Frame: Evaluated by consultations every 12 weeks, later every 6 monts. Up to 10 years. ]CTCAEv2 side effects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139360
|Department of Oncology, Haukeland University Hospital|
|Bergen, Norway, 5020|
|Principal Investigator:||Oddbjorn Straume, MD, PhD||Department of Oncology, Haukeland University Hospital|