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Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer

A Phase II Trial of Bevacizumab Plus Gemcitabine™ and Oxaliplatin™ as First Line Therapy in Metastatic or Locally Advanced (Unresectable) Pancreatic Cancer

NCT00222469•University of Oklahoma

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out if giving patients bevacizumab along with the chemotherapy drugs oxaliplatin and gemcitabine will improve overall survival. In addition, the study will find out what side effects patients may have by taking bevacizumab, oxaliplatin, and gemcitabine together.

Detailed Description

Design: * A phase II single arm study. All patients receive bevacizumab 10mg/kg and gemcitabine 1000mg/m2 on day 1 followed by oxaliplatin 100mg/m2 on day 2 of a 14 day cycle. Purpose: * The purpose of this study is to find out if giving patients bevacizumab, along with the chemotherapy drugs oxaliplatin and gemcitabine, will improve overall survival. In addition, the study will find out what side effects patients may have by taking bevacizumab, oxaliplatin and gemcitabine together. Enrollment: * Approximately 30 patients will be enrolled to the study between the University of Oklahoma and M.D. Anderson Cancer Center. Duration: * The study will be conducted over approximately 2 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age \>/= 18 years old
•ECOG performance status 0-2.
•Patients with metastatic or unresectable locally advanced adenocarcinoma of the pancreas.
•Patients who have recurrent disease post pancreaticoduodenectomy no earlier than 6 months after resection. Patients with recurrent disease who had completed adjuvant therapy in the form of radiation with or without radiosensitizing 5-fluorouracil (5-FU) 6 months prior to recurrence may be included.
•Signed informed consent/authorization is obtained prior to conducting any study specific screening procedures.
•No prior chemotherapy for advanced pancreatic cancer
•Patient must have measurable disease
•Use of effective means of contraception (men and women) in subjects of child-bearing potential
•Obstructive jaundice must be relieved before inclusion
•Adequate hepatic, renal, and bone marrow function: leukocytes \>= 3,000/uL, absolute neutrophil count \>= 1,500/uL, platelets \>= 100,000/uL, total bilirubin \< = 1.5 X institutional upper limits of normal (ULN), AST (SGOT)/ALT (SGPT) \<= 2.5 X institutional ULN, creatinine \<= 1.5 mg/dL

Exclusion Criteria

•Previous chemotherapy for pancreatic cancer.
•Patients who have recurrent disease within 6 months after pancreaticoduodenectomy or had received adjuvant therapy within 6 months of disease recurrence.
•Uncontrolled intercurrent illness including:
•* Active infection
•* Cardiovascular: New York Heart Association (NYHA) grade II or greater congestive heart failure, unstable angina pectoris, cardiac arrhythmias not well controlled with medication, myocardial infarction within the previous 6 months, blood pressure \> 150/100 mmHg
•* Clinically significant peripheral vascular disease
•* History of stroke within previous 6 months
•* Evidence of bleeding diathesis or coagulopathy
•Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study.
•Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to Day 0
+9 more criteria

Locations (2)

University of Oklahoma

Oklahoma City, Oklahoma, United States

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

August 1, 2005

Primary Completion Date

May 1, 2007

Completion Date

May 1, 2007

Last Updated

July 9, 2008

Enrollment

ACTUAL participants

Conditions

Metastatic Pancreatic Cancer

Interventions

bevacizumab

DRUG

gemcitabine

DRUG

oxaliplatin

DRUG

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

NCT07409272

Pancreatic CancerMetastatic Pancreatic Cancer+1 more

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RECRUITINGPHASE2

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

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Metastatic Pancreatic Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients

A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer

Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer