A Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme

NCT01115491 | Completed Phase 2 Results

• 2 other identifiers: ML251522010-019051-21
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 8

Brief Summary

This is a Phase II, national, multicenter, open-label, non-comparative study to investigate the efficacy and safety of bevacizumab and temozolomide in patients with recurrent glioblastoma multiforme (GBM) after a first treatment failure. Patients will receive bevacizumab 10 mg/kg intravenously every two weeks until disease progression, consent withdrawal, or unacceptable toxicity. Anticipated time on study treatment is 12-24 months.

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (3)

• Progression-Free Survival (PFS) - Percentage of Participants With an Event

  PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment.

  Baseline (BL), every 28 days, until progression, death or end-of-study, an average of 32 weeks

• PFS - Time to Event

  PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment. PFS was estimated using the Kaplan-Meier method.

  BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks

• PFS: Probability of Remaining Progression Free at 24 Weeks After Beginning the Study

  BL, 24 weeks (after 6th cycle)

Secondary Outcomes (3)

• Overall Survival - Percentage of Participants With an Event

  BL, every 28 days, until death or end-of-study, an average of 32 weeks

• Overall Survival - Time to Event

  BL, every 28 days, until death or end-of-study, an average of 32 weeks

• Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)

  BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks

Study Arms (1)

A

EXPERIMENTAL

Drug: bevacizumab [Avastin]; Drug: temozolomide

Interventions

bevacizumab [Avastin] DRUG

Bevacizumab 10 mg/kg body weight will be administered intravenously every two weeks

A

temozolomide DRUG

Daily by the oral route (dose, 150 mg/m2) on days 1 to 7 and 15 to 21 of each cycle

A

Eligibility Criteria

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

You may qualify if:

• Age \>= 18 years
• Histological diagnosis of glioblastoma multiforme (GBM) documented by surgical resection or biopsy.
• They should be patients in a first relapse treated with radiotherapy and chemotherapy and chemotherapy based on temozolomide 150-200 mg/m2 on days 1 to 5 every 28 days (Stupp regimen) for at least three cycles. At least 4 weeks must have lapsed since previous chemotherapy and 3 months since the last dose of radiotherapy.
• Use of an effective contraceptive method by patients and their partners.
• Stable or decreasing corticosteroid dose for the five days prior to study entry
• Adequate hematological function
• Adequate liver function
• Adequate kidney function

You may not qualify if:

• Signs of recent bleeding at the MRI of the brain. However, patients with clinically asymptomatic presence of hemosiderin, resolving bleeding changes related to surgery, and presence of punctate hemorrhage in the tumor will be allowed to participate in the study.
• Prior treatment with bevacizumab
• Poorly controlled arterial hypertension
• History of hypertensive crises or hypertensive encephalopathy
• New York Health Association (NYHA) Class II or higher congestive heart failure
• History of myocardial infarction or unstable angina pectoris within six months of study entry
• History of stroke or TIA within six months of study entry
• Significant vascular disease within six months of study entry
• History of hemoptysis \> grade 2 according to the NCI CTC criteria within one month of study entry
• Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
• Major surgery, open biopsy, intracranial biopsy, ventriculoperitoneal shunt, or major traumatic lesion within 28 days of study entry.
• Core needle biopsy (excluding intracranial biopsy) or other minor surgery within seven days of randomization. Placement of a central vascular access device (CVAD) if performed in the two days prior to bevacizumab administration
• History of abdominal fistula or gastrointestinal perforation within six months of study entry
• History of intracranial abscess within six months of randomization
• Any prior malignant neoplasm treated with curative intent in the five years prior to study entry, except for adequately controlled limited basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (8)

Unknown Facility

Barcelona, Barcelona, 08025, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08907, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08916, Spain

Location

Unknown Facility

Madrid, Madrid, 28040, Spain

Location

Unknown Facility

Madrid, Madrid, 28041, Spain

Location

Unknown Facility

Madrid, Madrid, 28046, Spain

Location

Unknown Facility

Valencia, Valencia, 41014, Spain

Location

Unknown Facility

Valencia, Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Bevacizumab; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 4, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: December 8, 2014
• Results First Posted: December 8, 2014

Record last verified: 2014-12

Locations

ES (8)