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

NCT01069627 | Completed Phase 2 Results

• 1 other identifier: ML19309
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

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.

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Complete Response (CR) or Partial Response (PR)

  The percentage of participants with an objective response, defined as achieving CR or PR, as evaluated by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.

  Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months

• Percentage of Participants With Clinical Benefit of CR, PR, or Stable Disease (SD)

  The percentage of participants with an objective response of CR, PR, or SD, as evaluated by RECIST criteria. CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target), PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD. SD: steady state of disease. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for pregressive disease (PD). The clinical benefit was finally assessed by computing absolute frequencies and percentages participants with best overall tumor response equal to CR, PR, or SD.

  Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months

Secondary Outcomes (16)

• Time to Progression (TTP) - Percentage of Participants With an Event

  Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months

• TTP - Time to Event

  Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months

• Duration of CR - Percentage of Participants With an Event

  Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months

• Duration of CR - Time to Event

  Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months

• Duration of Overall Response of CR or PR - Percentage of Participants With an Event

  Baseline, every 9 weeks during study treatment, and every 3 months during follow-up, up to 36 months

Study Arms (1)

1

EXPERIMENTAL

Drug: bevacizumab [Avastin]; Drug: fotemustine

Interventions

bevacizumab [Avastin] DRUG

15 mg/kg intravenously on day 1 of every 3 week cycle

1

fotemustine DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

Unknown Facility

Florence, 50100, Italy

Location

Unknown Facility

Genova, 16132, Italy

Location

Unknown Facility

Milan, 20133, Italy

Location

Unknown Facility

Torino, 10126, Italy

Location

Related Publications (1)

• 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. doi: 10.1158/1078-0432.CCR-10-2363. Epub 2010 Oct 28.

  PMID: 21030496 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

Bevacizumab; fotemustine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: February 17, 2010
• Study Start: December 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 6, 2018
• Results First Posted: June 25, 2014

Record last verified: 2018-11

Locations

IT (4)