A Study of Bevacizumab and Extended Treatment of Temozolo... | NCT01115491

NCT01115491

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2010-019051-21

Status Module

Label	Type	Description	Intervention Names
A	Experimental		Drug: bevacizumab [Avastin] Drug: temozolomide

Name	Type	Description	Arm Group Labels	Other Names
bevacizumab [Avastin]	Drug	Bevacizumab 10 mg/kg body weight will be administered intravenously every two weeks	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Overall Survival - Percentage of Participants With an Event	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.	BL, every 28 days, until death or end-of-study, an average of 32 weeks

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Arm/Group Information

ID	Title	Description
FG000	Bevacizumab + Temozolomide	Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg per square meter (mg/m^2), orally (PO), on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles. Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Bevacizumab + Temozolomide	Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles. Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

ITT population

Posted

Number

percentage of participants

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

ID	Title	Description
OG000	Bevacizumab + Temozolomide	Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles. Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bevacizumab + Temozolomide	Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles. Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression.

Facility	Status	City	State	ZIP	Country	Contacts
		Barcelona	Barcelona	08025	Spain

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins