Trial Outcomes & Findings for Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas (NCT NCT00612339)

Last Updated: 2013-05-27

Results Overview

The proportion of subjects with complete or partial response as determined by a modification of the RANO (Response Assessment in Neuro-Oncology) criteria. A confirmation of response was not required. Complete Response was defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses), accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks. Partial Response was defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids, accompanied by a stable or improving neurologic examination, and maintained for at least 4 weeks.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

4 months

Results posted on

2013-05-27

Participant Flow

Subjects were accrued between October 2007 and September 2008 within the clinic at Duke Comprehensive Cancer Center.

Participant milestones

Participant milestones
Measure	Avastin and Temozolomide Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
Overall Study STARTED	41
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Avastin in Combination With Temozolomide for Unresectable or Multifocal GBMs and Gliosarcomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Avastin and Temozolomide n=41 Participants Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age Continuous	58.6 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Population: All subjects

Outcome measures

Outcome measures
Measure	Avastin and Temozolomide n=41 Participants Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
Response Rate	24.4 percentage of patients Interval 12.4 to 40.3

Adverse Events

Avastin and Temozolomide

Serious events: 10 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Avastin and Temozolomide n=41 participants at risk Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
Gastrointestinal disorders ileus	2.4% 1/41 • 6 months CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.
Gastrointestinal disorders Small intestinal perforation	2.4% 1/41 • 6 months CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.
Gastrointestinal disorders Vomiting	4.9% 2/41 • 6 months CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.
Cardiac disorders Myocardial infarction	2.4% 1/41 • 6 months CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.
General disorders Death: Disease progression	4.9% 2/41 • 6 months CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.
Infections and infestations Anorectal infection	2.4% 1/41 • 6 months CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.
Injury, poisoning and procedural complications Wound dehiscence	2.4% 1/41 • 6 months CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.
Investigations Neutrophil count decreased	2.4% 1/41 • 6 months CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.
Metabolism and nutrition disorders Dehydration	2.4% 1/41 • 6 months CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.
Metabolism and nutrition disorders Hyperglycemia	2.4% 1/41 • 6 months CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.
Nervous system disorders Seizure	2.4% 1/41 • 6 months CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.
Vascular disorders Thromboembolic event	4.9% 2/41 • 6 months CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.

Other adverse events

Other adverse events
Measure	Avastin and Temozolomide n=41 participants at risk Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
General disorders Fatigue	7.3% 3/41 • 6 months CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.
Investigations Platelet count decreased	7.3% 3/41 • 6 months CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.
Nervous system disorders Peripheral motor neuropathy	14.6% 6/41 • 6 months CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.
Nervous system disorders Seizure	7.3% 3/41 • 6 months CTCAE (3.0) was used for collecting adverse events in this study. However, the events have been converted to CTCAE (4.0) for entry into clinicaltrials.gov. Only grade 3, grade 4, and grade 5 adverse events were collected.

Additional Information

Katherine Peters, MD, PhD

Duke University Medical Center

Phone: 9196846173

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place