Trial Outcomes & Findings for FOLFOX With Bevacizumab in Metastatic or Unresectable Gastroesophageal and Gastric Cancer (NCT NCT00673673)

NCT ID: NCT00673673

Last Updated: 2015-02-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 39 participants
• Primary outcome timeframe: Upon completion of study, up to 3 years
• Results posted on: 2015-02-04

Participant Flow

Participant milestones

Measure	FOLFOX/Bevacizumab Administration FOLFOX in combination with bevacizumab FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy
Overall Study STARTED	39
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	36

Reasons for withdrawal

Measure	FOLFOX/Bevacizumab Administration FOLFOX in combination with bevacizumab FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy
Overall Study Progressive disease	27
Overall Study Adverse Event	4
Overall Study Withdrawal by Subject	3
Overall Study Investigators' discretion	2

Baseline Characteristics

FOLFOX With Bevacizumab in Metastatic or Unresectable Gastroesophageal and Gastric Cancer

Baseline characteristics by cohort

Measure	FOLFOX/Bevacizumab Administration n=39 Participants FOLFOX in combination with bevacizumab FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy
Age, Continuous	62 years n=93 Participants
Sex: Female, Male Female	8 Participants n=93 Participants
Sex: Female, Male Male	31 Participants n=93 Participants

PRIMARY outcome

Timeframe: Upon completion of study, up to 3 years

Outcome measures

Measure

FOLFOX/Bevacizumab Administration n=39 Participants FOLFOX in combination with bevacizumab FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy

Progression Free Survival

7.8 months Interval 5.9 to 11.6

SECONDARY outcome

Timeframe: Upon completion of study

Per response evaulation criteria in solid tumors criteria (RECIST) for target lesions assessed by FDG-PET Scans: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.

Outcome measures

Measure

FOLFOX/Bevacizumab Administration n=39 Participants FOLFOX in combination with bevacizumab FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy

Overall Tumor Response Rate by RECIST Criteria

56.4 percentage of participants

SECONDARY outcome

Timeframe: Upon completion of study, up to 3 years

Outcome measures

Measure

FOLFOX/Bevacizumab Administration n=39 Participants FOLFOX in combination with bevacizumab FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy

Overall Survival

14.7 months Interval 11.5 to 16.6

Adverse Events

FOLFOX/Bevacizumab Administration

Serious events: 4 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	FOLFOX/Bevacizumab Administration n=39 participants at risk FOLFOX in combination with bevacizumab FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy
Blood and lymphatic system disorders Thromboytopenia	5.1% 2/39 • Toxicity assessment were performed up to 3 years
Nervous system disorders Neuropathy	2.6% 1/39 • Toxicity assessment were performed up to 3 years
Renal and urinary disorders Proteinuria	2.6% 1/39 • Toxicity assessment were performed up to 3 years

Other adverse events

Measure	FOLFOX/Bevacizumab Administration n=39 participants at risk FOLFOX in combination with bevacizumab FOLFOX: Oxaliplatin 85/mg/m2 IV infused over two hours followed by Leucovorin 400 mg/m2 IV over 2 hours, followed by 5-FU 400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours bevacizumab: bevacizumab will be used at a dose of 10 mg/kg administered every 2 weeks on day one of FOLFOX chemotherapy
Blood and lymphatic system disorders Anemia	2.6% 1/39 • Toxicity assessment were performed up to 3 years
Blood and lymphatic system disorders Neurtropenia	28.2% 11/39 • Toxicity assessment were performed up to 3 years
Blood and lymphatic system disorders Thrombocytopenia	5.1% 2/39 • Toxicity assessment were performed up to 3 years
General disorders Fatigue	7.7% 3/39 • Toxicity assessment were performed up to 3 years
Gastrointestinal disorders Mucositis	2.6% 1/39 • Toxicity assessment were performed up to 3 years
Gastrointestinal disorders Dysphagia	2.6% 1/39 • Toxicity assessment were performed up to 3 years
Gastrointestinal disorders Diarrhea	7.7% 3/39 • Toxicity assessment were performed up to 3 years
Gastrointestinal disorders Abdominal Pain	10.3% 4/39 • Toxicity assessment were performed up to 3 years
Skin and subcutaneous tissue disorders Hand-Foot Syndrome	2.6% 1/39 • Toxicity assessment were performed up to 3 years
Hepatobiliary disorders Abnormal Liver Function Tests	7.7% 3/39 • Toxicity assessment were performed up to 3 years
Respiratory, thoracic and mediastinal disorders Dyspnea	5.1% 2/39 • Toxicity assessment were performed up to 3 years
Nervous system disorders Neuropathy	20.5% 8/39 • Toxicity assessment were performed up to 3 years
General disorders Electrolytes Imbalence	5.1% 2/39 • Toxicity assessment were performed up to 3 years
Vascular disorders Deep Vein Thrombosis/Pulmonary Embolism	7.7% 3/39 • Toxicity assessment were performed up to 3 years
Vascular disorders Hypertension	2.6% 1/39 • Toxicity assessment were performed up to 3 years
Renal and urinary disorders Proteinuria	2.6% 1/39 • Toxicity assessment were performed up to 3 years

Additional Information

Dr. Jill Lacy

Yale University

Phone: 203-737-1600

Email: jill.lacy@yale.edu

Results disclosure agreements

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