Study of Bevacizumab in Combination With 5-FU, Oxaliplatin and External Beam Radiation Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer

NCT00307723 | Terminated Phase 1 DMC

• 1 other identifier: 05-233
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is determine the safety of bevacizumab, oxaliplatin, 5-FU, and gemcitabine in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect information about whether this combination treatment is effective in treating patients with locally advanced pancreatic cancer (Phase II portion).

Conditions

Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma

Keywords

EBRT; advanced pancreatic cancer

Outcome Measures

Primary Outcomes (2)

• To determine the safety and tolerability of the combination of bevacizumab, 5-FU, oxaliplatin, and EBRT for locally advanced pancreatic cancer

  2 years

• to determine the survival of patients treated with this regimen.

Secondary Outcomes (4)

• To determine the progression free survival

• to determine the rate of conversion to resectability after treatment

  2 years

• to asses the duration of response and response rate of this combination and

• to evaluate the toxicities.

  2 years

Study Arms (2)

Regimen Level 1

EXPERIMENTAL

Radiation/Oxaliplatin/5-FU

Drug: bevacizumab; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: gemcitabine; Procedure: External Beam Radiation Therapy

Regimen Level 2

EXPERIMENTAL

Radiation/Oxaliplatin/Bevacizumab/5-FU

Drug: bevacizumab; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: gemcitabine; Procedure: External Beam Radiation Therapy

Interventions

bevacizumab DRUG

Intravenously on days 1, 15 and 29 of the first cycle. Intravenously on days 1, 15 of each 28-day cycles for cycles 2-5.

Regimen Level 1; Regimen Level 2

5-Fluorouracil DRUG

Continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38 of cycle one.

Regimen Level 1; Regimen Level 2

Oxaliplatin DRUG

Intravenously on dasy 1, 8, 15, 22, 29, 36 of cycle one.

Regimen Level 1; Regimen Level 2

gemcitabine DRUG

Intravenously on days 1, 8, 25 of every 28-day cycle for cycles 2-5.

Regimen Level 1; Regimen Level 2

External Beam Radiation Therapy PROCEDURE

Monday through Friday ending on day 38 of cycle 1

Regimen Level 1; Regimen Level 2

Eligibility Criteria

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

You may qualify if:

• Histologically and radiologically confirmed locally advanced pancreatic ductal adenocarcinoma and have not received prior therapy
• Disease is measurable by CT scan
• Age \>= to 18 years
• Life expectancy of 4 months or longer
• ANC \>/= 1,500mm/cm3
• Hemoglobin \>/= 9g/dl
• Platelet count \>/= 100,000/cm3
• Total bilirubin \</= 2 times control
• SGOT/SGPT \</= 2.5 times upper limit of normal
• Serum creatinine \< 2mg/dl
• No evidence of metastatic disease by laparoscopy

You may not qualify if:

• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk for complications
• No secondary malignancies other than non-melanoma skin cancers or carcinoma in-situ of the cervix within past 5 years
• Patients with pre-existing peripheral neuropathy of grade 2 or greater
• Pregnant or lactating women
• Current, recent (within 4 weeks of study entry) or planned participation in an experimental drug study
• Blood pressure of \>150/100 mmHg
• Unstable angina
• New York Heart Association Grade II or greater congestive heart failure
• History of myocardial infarction or stroke within 6 months
• Clinically significant peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Presence of central nervous system or brain metastases
• Major surgical procedure, open biopsy,m or significant traumatic injury within 28 days prior to day 0
• Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0
• Urine protein creatinine ratio \> or = to 1.0 at screening

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Genentech, Inc.: collaborator
• Sanofi: collaborator

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Bevacizumab; Fluorouracil; Oxaliplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides

Study Officials

• Lawrence S. Blaszkowsky, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 24, 2006
• First Posted: March 28, 2006
• Study Start: May 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: July 1, 2009
• Last Updated: August 10, 2009

Record last verified: 2009-08