Metastatic Pancreatic CancerPhase 2NCT00222469
Combination Chemotherapy for 1st Line Treatment of Advanced or Metastatic Pancreatic Cancer
A Phase 2 study testing bevacizumab, gemcitabine and oxaliplatin in people with Metastatic Pancreatic Cancer, run by University of Oklahoma at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- bevacizumab, gemcitabine and oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Urine protein:creatinine ratio > 1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to Day 0
- Serious, non-healing wound, ulcer, or bone fracture
- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events. A computed tomography (CT) scan of the brain is not needed for eligibility and will be done only if the patient presents with symptoms suggestive of brain metastases.
- Patients may not be receiving any other investigational agents, or have participated in any investigational drug study within 28 days preceding start of study treatment.
- The teratogenic potential of this combination is currently unknown. Women who are pregnant or lactating are excluded.
- History of any other malignancy in the last 5 years, except patients with a prior history of in situ cancer or basal or squamous cell skin cancer.
- Peripheral neuropathy > grade 1
- Psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MD Anderson Cancer Center
Houston, Texas, 77030
University of Oklahoma
Oklahoma City, Oklahoma, 73104
About this study
Official title: A Phase II Trial of Bevacizumab Plus Gemcitabine™ and Oxaliplatin™ as First Line Therapy in Metastatic or Locally Advanced (Unresectable) Pancreatic Cancer
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.
Read the 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.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- bevacizumab, gemcitabine, oxaliplatin
- Keywords
- pancreatic cancer, unresectable pancreatic cancer, metastatic pancreatic cancer, bevacizumab, oxaliplatin, gemcitabine, 1st line treatment, first line treatment, locally advanced (unresectable) pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
10mg/kg IV on Day 1 Q 2 weeks
gemcitabineDrug
1000mg/m2 as fixed-rate infusion at 10mg/m2/min on Day 1 and Q 2 weeks.
oxaliplatinDrug
100mg/m2 on Day 2 and Q 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 3-agent treatment group Receives: Drug: bevacizumab; Drug: gemcitabine; Drug: oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the overall survival (OS) rate at 1 year in this patient population, treated with the combination therapy of bevacizumab plus gemcitabine and oxaliplatin
Measured: One year
Secondary outcomes (2)
To determine the objective tumor response rate in this patient population. To determine time to progression (TTP) and progression free survival (PFS) in this patient population
Measured: One year
To determine the tolerability and toxicity profile of this regimen in this patient population
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Sanofi, M.D. Anderson Cancer Center
- Investigators
- Mehrdad Jafari, MD, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222469
- Sponsor's protocol ID
- 2004-0652
- Status last verified
- Jul 2008
- First submitted
- 20 Sep 2005
- Last updated
- 9 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Bevacizumab Plus Gemcitabine™ and Oxaliplatin™ as First Line Therapy in Metastatic or Locally Advanced (Unresectable) Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00222469
- Acronym / sponsor ID
- 2004-0652
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- pancreatic cancer, unresectable pancreatic cancer, metastatic pancreatic cancer, bevacizumab, oxaliplatin, gemcitabine, 1st line treatment, first line treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Genentech, Inc., Sanofi, M.D. Anderson Cancer Center
- Study start
- Aug 2005
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bevacizumab, Drug: gemcitabine, Drug: oxaliplatin3-agent treatment group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (19 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumab10mg/kg IV on Day 1 Q 2 weeks | Drug | 1 |
| gemcitabine1000mg/m2 as fixed-rate infusion at 10mg/m2/min on Day 1 and Q 2 weeks. | Drug | 1 |
| oxaliplatin100mg/m2 on Day 2 and Q 2 weeks. | Drug | 1 |
Primary outcome
To determine the overall survival (OS) rate at 1 year in this patient population, treated with the combination therapy of bevacizumab plus gemcitabine and oxaliplatin
Time frame: One year
2 secondary outcomes
To determine the objective tumor response rate in this patient population. To determine time to progression (TTP) and progression free survival (PFS) in this patient population
Time frame: One year
To determine the tolerability and toxicity profile of this regimen in this patient population
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehrdad Jafari, MD, PhD principal investigator
University of Oklahoma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab, gemcitabine and oxaliplatin in people with Metastatic Pancreatic Cancer, run by University of Oklahoma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the overall survival (OS) rate at 1 year in this patient population, treated with the combination therapy of bevacizumab plus gemcitabine and oxaliplatin (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2008.