Trial Outcomes & Findings for Phase II Study of Doxorubicin and Avastin® in Sarcoma. (NCT NCT00755261)

Results Overview

Study was terminated because of low accrual.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

6 month PFS

Results posted on

2015-05-08

Only 4 subjects were accrued over 2 years. Study was closed due to slow accrual.

Participant milestones
Measure	Avastin and Doxorubicin Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance. Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes. Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter.
Overall Study STARTED	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	2

Withdrawal data not reported

Phase II Study of Doxorubicin and Avastin® in Sarcoma.

Baseline characteristics by cohort
Measure	Avastin and Doxorubicin n=6 Participants Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance. Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes. Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter.
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

Timeframe: 6 month PFS

Population: study was terminated because of low accrual (4 subjects enrolled/2 years)

Study was terminated because of low accrual.

Outcome data not reported

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events
Measure	Avastin and Doxorubicin n=4 participants at risk Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance. Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes. Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter.
Blood and lymphatic system disorders febrile neutropenia	25.0% 1/4 • Number of events 1 • none, study was terminated early because of low accrual.
Renal and urinary disorders acute renal failure	25.0% 1/4 • Number of events 1 • none, study was terminated early because of low accrual.

Other adverse events
Measure	Avastin and Doxorubicin n=4 participants at risk Patients will be treated with Avastin 15 mg/kg IV infusion plus doxorubicin 60 mg/M2 (body surface area) IV 6-hour infusion on Day 1 of each 21-day treatment cycle. Dose reductions/modifications will be applied as indicated by toxicities and/or patient tolerance. Avastin: Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes. Doxorubicin: The Day 1 6- hour continuous IV infusion must be done through a central venous catheter.
Infections and infestations thrush	25.0% 1/4 • Number of events 4 • none, study was terminated early because of low accrual.
Metabolism and nutrition disorders dehydration	25.0% 1/4 • Number of events 1 • none, study was terminated early because of low accrual.
Gastrointestinal disorders dysphagia -unable to swallow medications	25.0% 1/4 • Number of events 1 • none, study was terminated early because of low accrual.

SKCCC, Johns Hopkins University

Phone: 4105025940

Restriction type: GT60