Trial Outcomes & Findings for Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer (NCT NCT00217581)

Last Updated: 2019-03-26

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months

Results posted on

2019-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	Docetaxel, Oxaliplatin & Bevacizumab Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins. Bevacizumab: Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes.
Overall Study STARTED	39
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Docetaxel, Oxaliplatin & Bevacizumab Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins. Bevacizumab: Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Bevacizumab, Oxaliplatin, and Docetaxel in Treating Patients With Locally Advanced Unresectable or Metastatic Stomach or Gastroesophageal Junction Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Docetaxel, Oxaliplatin & Bevacizumab n=39 Participants Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins. Bevacizumab: Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Region of Enrollment United States	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: After every 2 cycles (1 cycle =21 days) From study registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months

Outcome measures

Outcome measures
Measure	Docetaxel, Oxaliplatin & Bevacizumab n=38 Participants Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins. Bevacizumab: Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes.
Time to Progression	6.6 months Interval 4.4 to 10.5

SECONDARY outcome

Timeframe: After every 2 cycles (1 cycle =21 days)

Percentage of Participants with response by RECIST criteria until progression

Outcome measures

Outcome measures
Measure	Docetaxel, Oxaliplatin & Bevacizumab n=38 Participants Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins. Bevacizumab: Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes.
Response Rate by RECIST Criteria	42 percentage of responders Interval 28.0 to 58.0

SECONDARY outcome

Timeframe: At 21 days following completion of study treatment

Toxicity profile of grade 3 and grade 4 events using the NCI-CTCAE Version 3.0 scale for toxicity grading.

Outcome measures

Outcome measures
Measure	Docetaxel, Oxaliplatin & Bevacizumab n=38 Participants Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins. Bevacizumab: Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes.
Toxicity Profile Neutropenia	13 Participants
Toxicity Profile Leukopenia	1 Participants
Toxicity Profile GI Perforation	3 Participants
Toxicity Profile TE Fistula	1 Participants
Toxicity Profile Hypertension	2 Participants
Toxicity Profile Venous Thromboemblism	1 Participants
Toxicity Profile Neuropathy	5 Participants
Toxicity Profile Nausea	4 Participants
Toxicity Profile Vomiting	2 Participants
Toxicity Profile Diarrhea	3 Participants
Toxicity Profile Dehydration	4 Participants
Toxicity Profile Fever	2 Participants
Toxicity Profile Fatigue	2 Participants
Toxicity Profile Anorexia	2 Participants

SECONDARY outcome

Timeframe: Every 21 days From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Time to treatment failure using the Kaplan-Meier method

Outcome measures

Outcome measures
Measure	Docetaxel, Oxaliplatin & Bevacizumab n=38 Participants Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins. Bevacizumab: Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes.
Time to Treatment Failure	4.5 months Interval 3.6 to 6.3

SECONDARY outcome

Timeframe: Patients will be followed for survival every three months after they are off study or until their disease progresses, for up to two years

Overall survival using the Kaplan-Meier method

Outcome measures

Outcome measures
Measure	Docetaxel, Oxaliplatin & Bevacizumab n=38 Participants Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins. Bevacizumab: Must be administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes.
Overall Survival	11.1 months Interval 8.2 to 15.3

Adverse Events

Docetaxel, Oxaliplatin & Bevacizumab

Serious events: 23 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Docetaxel, Oxaliplatin & Bevacizumab n=39 participants at risk Administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; 1st cycle, bevacizumab will be delivered over 90 +/- 15 mins. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 +/- 10 mins. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min +/- 10 mins. Bevacizumab: Administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 +/- 15 mins. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 +/- 10 mins. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min +/- 10 mins. Docetaxel: Must be administered 2nd after Bevacizumab then Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;
Investigations Neutrophils	33.3% 13/39 • Number of events 13
Gastrointestinal disorders Nausea	10.3% 4/39 • Number of events 4
Metabolism and nutrition disorders Dehydration	10.3% 4/39 • Number of events 4
Gastrointestinal disorders Late Dehydration	7.7% 3/39 • Number of events 3
Gastrointestinal disorders Gastrointestinal (GI) Perforation (not graded)	5.1% 2/39 • Number of events 2
Gastrointestinal disorders Vomiting	5.1% 2/39 • Number of events 2
Vascular disorders Hypertension	5.1% 2/39 • Number of events 2
General disorders Fatigue	5.1% 2/39 • Number of events 2
General disorders Fever	5.1% 2/39 • Number of events 2
Nervous system disorders Acute Neuropathy	5.1% 2/39 • Number of events 2
Investigations White Blood Count (WBC)	2.6% 1/39 • Number of events 1
Renal and urinary disorders Proteinuria	2.6% 1/39 • Number of events 1

Other adverse events

Other adverse events
Measure	Docetaxel, Oxaliplatin & Bevacizumab n=39 participants at risk Administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; 1st cycle, bevacizumab will be delivered over 90 +/- 15 mins. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 +/- 10 mins. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min +/- 10 mins. Bevacizumab: Administered 1st before Docetaxel \& Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 +/- 15 mins. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 +/- 10 mins. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min +/- 10 mins. Docetaxel: Must be administered 2nd after Bevacizumab then Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;
Gastrointestinal disorders Nausea	25.6% 10/39 • Number of events 10
Gastrointestinal disorders Late Diarrhea	30.8% 12/39 • Number of events 12
General disorders Fatigue	35.9% 14/39 • Number of events 14
Gastrointestinal disorders Vomiting	10.3% 4/39 • Number of events 4
Nervous system disorders Acute Neuropathy	23.1% 9/39 • Number of events 9
Vascular disorders Hypertension	12.8% 5/39 • Number of events 5
Investigations WBC	5.1% 2/39 • Number of events 2
Investigations Hemoglobin (HGB)	7.7% 3/39 • Number of events 3
Nervous system disorders Chronic Neuropathy	12.8% 5/39 • Number of events 5

Additional Information

Philip A. Philip, M.D., Ph.D., F.R.C.P

Barbara Ann Karmanos Institute

Phone: (313) 576-8746

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place