A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma

NCT00881504 | Terminated Phase 2 Results DMC

• 2 other identifiers: OX-07-0062007-411
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study is for patients with biliary tract cancer that has spread and who are not candidates for surgical resection. The purpose of this research is to determine if bevacizumab can be safely administered with Modified FOLFOX 6 and find out what effects, good and/or bad, this type of treatment has on biliary cancer. In this study, a combination of chemotherapy, Modified FOLFOX6 and a biologic agent, bevacizumab will be tested. Subjects on this study will receive chemotherapy and bevacizumab every 2 weeks until their disease gets worse or they are unable to tolerate treatment.

Conditions

Biliary Tract Cancer

Keywords

Biliary; Oxaliplatin; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

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

  2 years

Secondary Outcomes (1)

• Safety and Toxicity

  8 weeks

Study Arms (1)

"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

"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

Also known as: Avastin, Eloxatin

"FOLFOX6" and "Bevacizumab"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead
• Sanofi: collaborator

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Bevacizumab; Oxaliplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Dr. John L Marshall
• Organization: Georgetown University Medical Center

marshalj@georgetown.edu

202-444-7064

Study Officials

• John L Marshall, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 15, 2009
• Study Start: June 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 20, 2014
• Results First Posted: October 20, 2014

Record last verified: 2014-09

Locations

US (1)