Trial Outcomes & Findings for Abraxane and Avastin as Therapy for Patients With Malignant Melanoma, a Phase II Study (NCT NCT00462423)

NCT ID: NCT00462423

Last Updated: 2014-01-08

Results Overview

Progression-free survival at 4 months from first treatment as determined by RECIST 1.0

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: 4 months.
• Results posted on: 2014-01-08

Participant Flow

Participant milestones

Measure	Single Arm, Open Label Single Arm, Open Label trial of Abraxane and Avastin Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period).
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Abraxane and Avastin as Therapy for Patients With Malignant Melanoma, a Phase II Study

Baseline characteristics by cohort

Measure	Single Arm, Open Label n=50 Participants Single Arm, Open Label trial of Abraxane and Avastin Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period).
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=93 Participants
Age, Categorical >=65 years	21 Participants n=93 Participants
Age, Continuous	62 years FULL_RANGE NA • n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	32 Participants n=93 Participants
Region of Enrollment United States	50 participants n=93 Participants

PRIMARY outcome

Timeframe: 4 months.

Progression-free survival at 4 months from first treatment as determined by RECIST 1.0

Outcome measures

Measure	Single Arm, Open Label n=50 Participants Single Arm, Open Label trial of Abraxane and Avastin Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period).
Progression-free Survival (PFS) at 4 Months	75 percentage of patients Interval 63.0 to 87.0

SECONDARY outcome

Timeframe: From start of treatment to disease progressin; median duration of follow-up for surviving patients was 41.6 months.

Median time of progression-free survival from first treatment according to RECIST 1.0

Outcome measures

Measure	Single Arm, Open Label n=50 Participants Single Arm, Open Label trial of Abraxane and Avastin Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period).
Progression-free Survival	7.63 Months Interval 5.56 to 9.93

SECONDARY outcome

Timeframe: April 2007 through December 2010

The duration of overall survival was defined as the number of months between the start date of protocol treatment and the date of death (irrespective of cause), and was right-censored at the date of last contact for patients who were alive as of the data cutoff.

Outcome measures

Measure	Single Arm, Open Label n=50 Participants Single Arm, Open Label trial of Abraxane and Avastin Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period).
Overall Survival (OS)	16.8 months Interval 12.6 to 20.7

SECONDARY outcome

Timeframe: The median duration of follow-up for surviving patients was 41.6 months.

The objective response rate is defined as the percentage of patients showing complete or partial response.

Outcome measures

Measure	Single Arm, Open Label n=50 Participants Single Arm, Open Label trial of Abraxane and Avastin Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period).
Objective Response Rate (RR) in Patients With Measurable Lesions Time to Objective Response	36 Percentage of participants Interval 23.0 to 51.0

SECONDARY outcome

Timeframe: April 2007 through December 2010

See adverse events Table

Outcome measures

Outcome data not reported

Adverse Events

Single Arm, Open Label

Serious events: 13 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Single Arm, Open Label n=50 participants at risk Single Arm, Open Label trial of Abraxane and Avastin Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period).
Cardiac disorders Atrial Flutter	2.0% 1/50 • Number of events 1 • 3 years.
Respiratory, thoracic and mediastinal disorders Hemoptysis	2.0% 1/50 • Number of events 1 • 3 years.
Gastrointestinal disorders Small intestinal perferation	2.0% 1/50 • Number of events 1 • 3 years.
Cardiac disorders Supraventricular tachycardia	2.0% 1/50 • Number of events 1 • 3 years.
Renal and urinary disorders Nephrotic syndrome	2.0% 1/50 • Number of events 1 • 3 years.
Nervous system disorders Transient ischemic attack	2.0% 1/50 • Number of events 1 • 3 years.
Blood and lymphatic system disorders Pulmonary embolism	2.0% 1/50 • Number of events 1 • 3 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	4.0% 2/50 • Number of events 2 • 3 years.
Renal and urinary disorders Renal tubular necrosis	2.0% 1/50 • Number of events 1 • 3 years.
Gastrointestinal disorders Bowel perforation	2.0% 1/50 • Number of events 1 • 3 years.
Musculoskeletal and connective tissue disorders Palmar-plantar erythrodysesthesia	2.0% 1/50 • Number of events 1 • 3 years.
Eye disorders Macular edema	2.0% 1/50 • Number of events 1 • 3 years.

Other adverse events

Measure	Single Arm, Open Label n=50 participants at risk Single Arm, Open Label trial of Abraxane and Avastin Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period).
Nervous system disorders Peripheral neuropathy	10.0% 5/50 • Number of events 5 • 3 years.
Blood and lymphatic system disorders Neutropenia	12.0% 6/50 • Number of events 6 • 3 years.

Additional Information

Lynn E. Spitler, MD

Northern California Medical Center

Phone: 415-435-9861

Email: lynn@drspitler.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60