Pancreatic CancerPhase 1NCT00047710
Study of Combined RHUMAB VEGF and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer
A Phase 1 study testing Bevacizumab, Capecitabine and Radiotherapy in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest safe dose of the drug Bevacizumab that can be given in combination with chemoradiation for the treatment of pancreatic cancer. The effect that this combination treatment has on the tumor will also be studied. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Bevacizumab, Capecitabine and Radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Jul 2006
- Phase
- Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Cytology or histologic proof of adenocarcinoma of the pancreatic head, body or tail prior to treatment.
- Patients with nonmetastatic, unresectable, disease are eligible.
- Patients with regional nodal disease are eligible.
- Karnofsky performance status >/=70.
- No upper age restriction.
- Absolute granulocyte count >1,500 cells/mm3 and platelet count at least 100,000 cells/mm3.
Show all 12Show fewer
- Serum bilirubin less than 5mg/dl prior to the start of therapy with adequate biliary decompression.
- Adequate bilateral renal function.
- Serum creatinine <1.5 mg/dl.
- Adequate liver function; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST)</=5 times upper limit of normal.
- Sexually active men must practice contraception during study.
- Patients must sign study-specific consent form.
Who cannot join
- History or evidence upon physical examination of CNS disease.
- Active infection requiring parenteral antibiotics on Day 0. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
- Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agent.
- Chronic, daily treatment with aspirin or nonsteroidal anti-inflammatory medications.
- Pregnancy or lactation.
- Proteinuria at baseline or impairment of renal function.
Show all 12Show fewer
- Serious, nonhealing wound, ulcer, or bone fracture.
- Evidence of bleeding diathesis or coagulopathy
- Clinically significant cardiovascular disease, congestive heart failure, serous cardiac arrhythmia requiring medication, or significant peripheral vascular disease within 1 year prior to Day 0.
- History of aneurysms, strokes, transient ischemic attacks, and arteriovenous malformations.
- Serous concomitant medical or psychiatric disorders.
- Cohort receiving Capecitabine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MDAnderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase I Trial of Concurrent RHUMAB VEGF (BEVACIZUMAB) and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer
The goal of this clinical research study is to find the highest safe dose of the drug Bevacizumab that can be given in combination with chemoradiation for the treatment of pancreatic cancer. The effect that this combination treatment has on the tumor will also be studied.
Read the detailed description
This study administers 50.4 Gy of radiation for unresectable pancreatic cancer with concurrent capecitabine and an experimental drug, Bevacizumab. The drug is an antiangiogenic agent (kills tumor blood vessels) and has been shown in preclinical models to enhance the antitumor effect of radiation and chemotherapy.
- Conditions
- Pancreatic Cancer
- Being tested
- Bevacizumab, Capecitabine, Radiotherapy
- Keywords
- pancreatic cancer, pancreas cancer, pancreas
- 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
Also called Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF
Beginning 2 weeks prior to radiotherapy, dose of 5 mg/kg by vein then of 2.5 mg/kg during radiotherapy for four weeks every 2 weeks (three doses).
CapecitabineDrug
Also called Xeloda
650mg/m^2 taken by mouth twice a day 15-52 during the radiotherapy.
RadiotherapyRadiation
Also called XRT
Radiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Experimental | Radiation, Bevacizumab, and Capecitabine Receives: Drug: Bevacizumab; Drug: Capecitabine; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of combination Radiation, Bevacizumab, and Capecitabine.
Measured: 6 weeks after the completion of therapy
Secondary outcomes (4)
To evaluate the local tumor response and median survival in patients treated with the above regimen.
Measured: 6 weeks after the completion of therapy.
To evaluate VEGF serum levels before and after anti-VEGF therapy.
Measured: 6 weeks after the completion of therapy.
To evaluate tumor hypoxia via PET scanning (gallium PET with the novel hypoxia tracer Ga-68 ECMN) before, during, and after therapy.
Measured: 6 weeks after the completion of therapy.
To evaluate quality of life in patients receiving this therapy.
Measured: 6 weeks after the completion of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2002 (estimated)
- Study startSep 2002
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Christopher H. Crane, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047710
- Sponsor's protocol ID
- ID02-146
- Status last verified
- Jul 2012
- First submitted
- 14 Oct 2002
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Concurrent RHUMAB VEGF (BEVACIZUMAB) and Capecitabine-based Chemoradiation for Patients With Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00047710
- Acronym / sponsor ID
- ID02-146
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, pancreas cancer, pancreas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Sep 2002
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 16 Oct 2002 (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 goal of this clinical research study is to find the highest safe dose of the drug Bevacizumab that can be given in combination with chemoradiation for the treatment of pancreatic cancer. The effect that this combination treatment has on the tumor will also be studied.
Detailed description
This study administers 50.4 Gy of radiation for unresectable pancreatic cancer with concurrent capecitabine and an experimental drug, Bevacizumab. The drug is an antiangiogenic agent (kills tumor blood vessels) and has been shown in preclinical models to enhance the antitumor effect of radiation and chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: Bevacizumab, Drug: Capecitabine, Radiation: RadiotherapyRadiation, Bevacizumab, and Capecitabine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Cytology or histologic proof of adenocarcinoma of the pancreatic head, body or tail prior to treatment.
- Patients with nonmetastatic, unresectable, disease are eligible.
- Patients with regional nodal disease are eligible.
- Karnofsky performance status >/=70.
- No upper age restriction.
Key exclusion criteria (12 listed)
- History or evidence upon physical examination of CNS disease.
- Active infection requiring parenteral antibiotics on Day 0. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
- Current or recent use of full-dose oral or parenteral anticoagulants or thrombolytic agent.
- Chronic, daily treatment with aspirin or nonsteroidal anti-inflammatory medications.
- Pregnancy or lactation.
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 |
|---|---|---|
| BevacizumabAlso: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGFBeginning 2 weeks prior to radiotherapy, dose of 5 mg/kg by vein then of 2.5 mg/kg during radiotherapy for four weeks every 2 weeks (three doses). | Drug | Bevacizumab |
| CapecitabineAlso: Xeloda650mg/m^2 taken by mouth twice a day 15-52 during the radiotherapy. | Drug | Bevacizumab |
| RadiotherapyAlso: XRTRadiography given once a day for 5 days at 50.4 Gy in 28 fractions over 5.5 weeks. | Radiation | Bevacizumab |
Primary outcome
Safety of combination Radiation, Bevacizumab, and Capecitabine.
Time frame: 6 weeks after the completion of therapy
4 secondary outcomes
To evaluate the local tumor response and median survival in patients treated with the above regimen.
Time frame: 6 weeks after the completion of therapy.
To evaluate VEGF serum levels before and after anti-VEGF therapy.
Time frame: 6 weeks after the completion of therapy.
To evaluate tumor hypoxia via PET scanning (gallium PET with the novel hypoxia tracer Ga-68 ECMN) before, during, and after therapy.
Time frame: 6 weeks after the completion of therapy.
To evaluate quality of life in patients receiving this therapy.
Time frame: 6 weeks after the completion of therapy.
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 1 Aug 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Christopher H. Crane, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bevacizumab, Capecitabine and Radiotherapy in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site 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 12 inclusion and 12 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 1 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety of combination Radiation, Bevacizumab, and Capecitabine. (time frame: 6 weeks after the completion of therapy). 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 1 Aug 2012.