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

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ClinicalTrials.gov Identifier: NCT01115491
Recruitment Status : Completed
First Posted : May 4, 2010
Results First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE April 30, 2010
First Posted Date  ICMJE May 4, 2010
Results First Submitted Date May 28, 2014
Results First Posted Date December 8, 2014
Last Update Posted Date December 8, 2014
Study Start Date  ICMJE June 2010
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
  • Progression-Free Survival (PFS) - Percentage of Participants With an Event [ Time Frame: Baseline (BL), every 28 days, until progression, death or end-of-study, an average of 32 weeks ]
    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 - Time to Event [ Time Frame: BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks ]
    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.
  • PFS: Probability of Remaining Progression Free at 24 Weeks After Beginning the Study [ Time Frame: BL, 24 weeks (after 6th cycle) ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2010)
Progression-free survival (PFS) at 6 months (24 weeks) [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT01115491 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
  • Overall Survival - Percentage of Participants With an Event [ Time Frame: BL, every 28 days, until death or end-of-study, an average of 32 weeks ]
    Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact.
  • Overall Survival - Time to Event [ Time Frame: BL, every 28 days, until death or end-of-study, an average of 32 weeks ]
    Overall survival was defined as the time transpired (in weeks) between the date of the participant's inclusion in the trial until the date of his/her death by any cause. Participants that were alive at the time the analysis was performed were censored on the date of last contact. Median overall survival was estimated using the Kaplan-Meier method.
  • Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR) [ Time Frame: BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks ]
    Overall response was defined as the percentage of participants who obtained CR or PR using adapted MacDonald criteria. CR: disappearance of all index and non-index lesions, confirmed no less than 4 weeks after assessment, no evidence of disease progression; corticosteroid dosage at or below 20 mg hydrocortisone daily; no neurological changes or an improvement as compared to last disease assessment. PR was defined as: Fifty percent or greater decrease in the sum of products of the larger diameter and the larger perpendicular diameter of all index lesions confirmed no less than 4 weeks after assessment, no evidence of disease progression and the absence of progressive, or non-evaluable disease status for non-index legions; unchanged, or decreased corticosteroid dose as compared to the last disease assessment; no neurological changes or an improvement as compared to the neurological examination at last disease assessment.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2010)
  • Objective response rate (ORR) [ Time Frame: 24 months ]
  • Overall Survival (OS) [ Time Frame: 24 months ]
  • Progression-free survival [ Time Frame: 24 months ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme
Official Title  ICMJE A Single Arm Phase II Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE
  • Drug: bevacizumab [Avastin]
    Bevacizumab 10 mg/kg body weight will be administered intravenously every two weeks
  • Drug: temozolomide
    Daily by the oral route (dose, 150 mg/m2) on days 1 to 7 and 15 to 21 of each cycle
Study Arms Experimental: A
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: temozolomide
Publications * Not Provided

*   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
Actual Enrollment  ICMJE
 (submitted: March 16, 2012)
32
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2010)
33
Actual Study Completion Date July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Patients with any other metabolic or psychological disease
  • Hypersensitivity to products derived from Chinese hamster ovary cells or to other humanized or recombinant human antibodies
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01115491
Other Study ID Numbers  ICMJE ML25152
2010-019051-21
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date December 2014

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