A Study of FOLFOX6 With Bevacizumab for Biliary System Ca... | NCT00881504

NCT00881504

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2007-411	Other Identifier	IRB

Status Module

Name	Class
Sanofi	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
"FOLFOX6" and "Bevacizumab"	Experimental	Intervention = "bevacizumab" in combination with chemotherapy Treatment of biliary system carcinoma using "Bevacizumab" in combination with "modified FOLFOX6".	Drug: "Bevacizumab" in combination with "modified FOLFOX6".

Interventions

Name	Type	Description	Arm Group Labels	Other Names
"Bevacizumab" in combination with "modified FOLFOX6".	Drug	Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks

Measure	Description	Time Frame
Progression-free Survival	Progression-free Survival is defined as the time from randomization (or study initiation) until objective tumor progression or death.	2 years

Measure	Description	Time Frame
Safety and Toxicity	The number of patients who underwent FOLFOX dose reductions as a result of Grade 3 toxicity.	8 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of non-resectable adenocarcinoma of the biliary tract, including carcinomas of the gallbladder, the intrahepatic or extrahepatic biliary tract, and ampullary cancer
Measurable or evaluable disease
Locally advanced disease that is inoperable ot patients who have had disease recurrence after curative surgical attempt
Ambulatory with an ECOG performance status of 0-1
Adequate organ and marrow function
Must agree to avoid pregnancy prior to study entry and throughout the duration of study participation
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Any prior chemotherapy
Patients who are receiving other investigational agents
Patients who have received radiotherapy to more than 25% of their bone marrow for any reason
Peripheral neuropathy >/= 2
Known brain metastases, uncontrolled seizure disorder, encephalitis
Prior history of hypertensive crisis or hypertensive encephalopathy, uncontrolled hypertension,unstable angina, congestive heart failure of New York Heart Association (NYHA) class 2 or greater, left ventricular ejection fraction less than 50%, clinically significant vascular disease, serious cardiac arrhythmia requiring medication, cardiomyopathy
History of myocardial infarction, unstable angina or stroke/transient ischemic attack (TIA) within 6 months
History of allergy to oxaliplatin, 5-fluoruracil (5-FU), Leucovorin, or Bevacizumab
History of intra-abdominal abscess within 4 weeks of study entry, abdominal fistula, gastrointestinal perforation, active peptic ulcer disease, or inflammatory bowel disease
Evidence of bleeding diathesis or coagulopathy
Serious non-healing wound, ulcer, or bone fracture
Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks of study entry or anticipation of need for major surgery during the course of the study
Minor surgical procedures such as core biopsies within 7 days before enrollment, chemotherapy port placement within 24 hours
Patients on full-dose anticoagulants who have out of range international normalized ratio (INR) or active bleeding
Concurrent malignancy unless the subject has been curatively treated and disease free for >/= 2 years or the cancer was non-melanoma skin cancer or early cervical cancer
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
Known HIV or Hepatitis B or C
Life expectancy less than 12 weeks
Pregnant or nursing women

Name	Affiliation	Role
John L Marshall, MD	Georgetown University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Georgetown University Medical Center		Washington D.C.	District of Columbia	20007	United States

ID	Title	Description
FG000	FOLFOX6 and Bevacizumab	Treatment with modified FOLFOX6 and Bevacizumab Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	FOLFOX6 and Bevacizumab	Treatment with modified FOLFOX6 and Bevacizumab Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-free Survival

Progression-free Survival is defined as the time from randomization (or study initiation) until objective tumor progression or death.

Primary outcome of 4 participants out of 8 was undetermined due to several reasons including patient refusal of further follow up.

Of the 4 patients remaining for analysis, progression free survival of 34, 26.3, 7, and 4.7 weeks was seen.

Posted

Median

Full Range

weeks

2 years

ID	Title	Description
OG000	FOLFOX6 and Bevacizumab	Treatment with modified FOLFOX6 and Bevacizumab Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	FOLFOX6 and Bevacizumab	Treatment with modified FOLFOX6 and Bevacizumab Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001660	Biliary Tract Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins