A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma

This study has been completed.

Sponsor:

Information provided by:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01069627

First received: December 15, 2009

Last updated: January 18, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 15, 2009

Last Updated Date

January 18, 2011

Start Date ^ICMJE

Not Provided

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall response rate (ORR) [ Time Frame: From study start through study completion or early study discontinuation ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01069627 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to progression (TTP) [ Time Frame: From start of treatment to the onset of disease progression, or death, or the last date the patient was known to be progression-free or alive ] [ Designated as safety issue: No ]
Duration of response (DR) [ Time Frame: From the day of response evidence to the day of disease progression ] [ Designated as safety issue: No ]
Overall survival (OS) [ Time Frame: From start of treatment up to death or the last date the patient was known to be alive ] [ Designated as safety issue: No ]
Time to treatment failure (TTF) [ Time Frame: From start of treatment to evidence of treatment failure ] [ Designated as safety issue: No ]
Frequency of adverse events (AEs) [ Time Frame: From study start through study completion or early study discontinuation ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Avastin (Bevacizumab) in Combination With Fotemustine in Patients With Metastatic Melanoma

Official Title ^ICMJE

An Open-label Study to Assess the Anti-tumor Activity of Avastin in Combination With Fotemustine as First-line Therapy in Patients With Metastatic Melanoma

Brief Summary

This study will investigate the efficacy and safety of bevacizumab + fotemustine in patients with stage IV melanoma, previously untreated with chemo- or immunotherapy for metastatic disease. Patients will receive Avastin (15mg/kg intravenously[IV]) on Day 1 of every 3 week cycle, in combination with fotemustine (100mg/m² IV) on Days 1, 8 and 15, followed by 4 weeks rest, followed by 100mg/m² IV every 3 weeks for 4-6 cycles. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Malignant Melanoma

Intervention ^ICMJE

Drug: bevacizumab [Avastin]
15 mg/kg intravenously on day 1 of every 3 week cycle
Drug: fotemustine
100 mg/m² intravenously on Days 1, 8, and 15, followed by 4 weeks of rest, then every 21 days up to 4 to 6 cycles

Study Arm (s)

Experimental: 1

Interventions:

Drug: bevacizumab [Avastin]
Drug: fotemustine

Publications *

Del Vecchio M, Mortarini R, Canova S, Di Guardo L, Pimpinelli N, Sertoli MR, Bedognetti D, Queirolo P, Morosini P, Perrone T, Bajetta E, Anichini A. Bevacizumab plus fotemustine as first-line treatment in metastatic melanoma patients: clinical activity and modulation of angiogenesis and lymphangiogenesis factors. Clin Cancer Res. 2010 Dec 1;16(23):5862-72. Epub 2010 Oct 28.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

cutaneous malignant melanoma;
advanced, inoperable stage IV melanoma;
measurable and/or evaluable sites of metastases.

Exclusion Criteria:

prior chemotherapy and/or IFN/IL2 based immunotherapy for metastatic disease;
prior malignancies within past 5 years, with the exception of cured non-melanoma skin cancer, or in situ cancer of cervix;
clinically significant cardiovascular disease;
ongoing treatment with aspirin (>325mg/day) or other medications known to predispose to gastrointestinal ulceration.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Italy

Administrative Information

NCT Number ^ICMJE

NCT01069627

Other Study ID Numbers ^ICMJE

ML19309

Has Data Monitoring Committee

Not Provided

Responsible Party

Disclosures Group, Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top