Loco-regional Esophageal CancerPhase 2NCT00570531
Phase II Trial for Patients With Loco-Regional Esophageal Carcinoma
A Phase 2 study testing Bevacizumab, Paclitaxel and Cisplatin in people with Loco-regional Esophageal Cancer, run by University of Michigan Rogel Cancer Center.
Trial summary
The purpose of this study is to determine whether bevacizumab can improve the outcome of treatment for patients with esophageal cancer whose disease is confined to the esophagus or the closely surrounding lymph nodes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Loco-regional Esophageal Cancer
- What is being tested?
- Bevacizumab, Paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Jun 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No prior treatment for esophageal cancer
- No prior radiation to the chest or upper abdominal area
- No prior treatment with an EGFR inhibitor or an anti-angiogenic agent
- Disease should be limited to the esophagus and regional lymph nodes -
Who cannot join
- History of stroke
- History of heart attack
- Inadequately controlled high blood pressure
About this study
Official title: Phase II Trial of Pre-Operative Chemoradiation Plus Bevacizumab, Followed by Surgery, and Post-Operative Adjuvant Bevacizumab for Patients With Loco-Regional Esophageal Carcinoma
The purpose of this study is to determine whether bevacizumab can improve the outcome of treatment for patients with esophageal cancer whose disease is confined to the esophagus or the closely surrounding lymph nodes.
Read the detailed description
Standard treatment is pre-operative chemotherapy and radiation, followed by surgery. In this study, bevacizumab will be added to the pre-operative chemotherapy and radiation, and then bevacizumab will also be administered for a year after surgery. Bevacizumab is a humanized monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer) produced by Genentech, Inc. using recombinant DNA technology. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal cancer in combination with chemotherapy. Bevacizumab is experimental in the treatment of esophageal cancer and has not been approved by the FDA for the treatment of esophageal cancer. Bevacizumab is an antibody directed against vascular endothelial growth factor, or VEGF. VEGF is a growth factor with a well defined role in normal and abnormal blood vessel formation. It is present in a wide variety of normal tissues, but is produced in excess by most solid cancers (tumors). In the setting of cancer, VEGF promotes the growth of blood vessels that bring nutrients to tumor cells. In studies with laboratory animals, bevacizumab inhibits the growth of several different types of human cancer cells, including colon cancer cells, by blocking the effects of VEGF. By blocking VEGF, your doctors hope that bevacizumab may decrease blood supply to the tumor, and therefore decrease the ability of the tumor to grow and come back after chemotherapy, radiation, and surgery.
- Conditions
- Loco-regional Esophageal Cancer
- Being tested
- Bevacizumab, Paclitaxel, Cisplatin, 5-Fluorouracil, Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days # 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.
PaclitaxelDrug
Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m2 will be administered as a 1-hour intravenous infusion on days #2, 9, 16, 23, and 30. It will be given before cisplatin administration.
CisplatinDrug
Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m2 over 1 hour on days #2, 9, 16, 23, and 30. It will be given after paclitaxel.
5-FluorouracilDrug
Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.
Radiation TherapyRadiation
Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays. CT scans, the barium swallow, the endoscopy and endoscopic ultrasound reports and PET scans should be used for tumor definition. Post-Operative Radiotherapy: In the event that gross residual disease is left behind at the time of surgery or the patient is found to have a microscopic positive deep or gastric margin following surgery, additional treatment with radiation therapy will be considered.
EsophagectomyProcedure or surgery
Transhiatal esophagectomy performed on approximately Day #57 (6 weeks after last dose of bevacizumab.)
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Experimental | Not described Receives: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Cisplatin; Drug: 5-Fluorouracil; Radiation: Radiation Therapy; Procedure: Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival Time
The primary outcome that will be measured is the length of time that patients are alive without recurrence of cancer following this therapy.
Measured: 5 years
Secondary outcomes (2)
The Number of Patients Cancer Free at the Time of Surgery
Determination of whether the pre-operative treatment can eliminate all the cancer cells at the time of surgery.
Measured: 1 year
The Proportion of Toxicities Experienced by Participants
To assess the toxicity of this regimen.
Measured: Every three weeks for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2010
- Study completionJun 2013
Why it stopped: The study was unable the accrue the required number of patients within a reasonable time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Loco-regional Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Susan Urba, MD, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570531
- Sponsor's protocol ID
- UMCC 2006.117
- Other IDs
- HUM 8625
- Status last verified
- Apr 2016
- First submitted
- 10 Dec 2007
- Last updated
- 26 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Pre-Operative Chemoradiation Plus Bevacizumab, Followed by Surgery, and Post-Operative Adjuvant Bevacizumab for Patients With Loco-Regional Esophageal Carcinoma
- ClinicalTrials.gov ID
- NCT00570531
- Acronym / sponsor ID
- UMCC 2006.117
- Conditions
- Loco-regional Esophageal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was unable the accrue the required number of patients within a reasonable time.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jun 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Dec 2007 (estimated)
- Results
- Posted 12 Jan 2015
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 determine whether bevacizumab can improve the outcome of treatment for patients with esophageal cancer whose disease is confined to the esophagus or the closely surrounding lymph nodes.
Detailed description
Standard treatment is pre-operative chemotherapy and radiation, followed by surgery. In this study, bevacizumab will be added to the pre-operative chemotherapy and radiation, and then bevacizumab will also be administered for a year after surgery. Bevacizumab is a humanized monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer) produced by Genentech, Inc. using recombinant DNA technology. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal cancer in combination with chemotherapy. Bevacizumab is experimental in the treatment of esophageal cancer and has not been approved by the FDA for the treatment of esophageal cancer. Bevacizumab is an antibody directed against vascular endothelial growth factor, or VEGF. VEGF is a growth factor with a well defined role in normal and abnormal blood vessel formation. It is present in a wide variety of normal tissues, but is produced in excess by most solid cancers (tumors). In the setting of cancer, VEGF promotes the growth of blood vessels that bring nutrients to tumor cells. In studies with laboratory animals, bevacizumab inhibits the growth of several different types of human cancer cells, including colon cancer cells, by blocking the effects of VEGF. By blocking VEGF, your doctors hope that bevacizumab may decrease blood supply to the tumor, and therefore decrease the ability of the tumor to grow and come back after chemotherapy, radiation, and surgery.
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: Paclitaxel, Drug: Cisplatin, Drug: 5-Fluorouracil, Radiation: Radiation Therapy, Procedure: Esophagectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No prior treatment for esophageal cancer
- No prior radiation to the chest or upper abdominal area
- No prior treatment with an EGFR inhibitor or an anti-angiogenic agent
- Disease should be limited to the esophagus and regional lymph nodes -
Key exclusion criteria (3 listed)
- History of stroke
- History of heart attack
- Inadequately controlled high blood pressure
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: AvastinPre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days # 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery. | Drug | Bevacizumab |
| PaclitaxelPre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m2 will be administered as a 1-hour intravenous infusion on days #2, 9, 16, 23, and 30. It will be given before cisplatin administration. | Drug | Bevacizumab |
| CisplatinPre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m2 over 1 hour on days #2, 9, 16, 23, and 30. It will be given after paclitaxel. | Drug | Bevacizumab |
| 5-FluorouracilPre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33. | Drug | Bevacizumab |
| Radiation TherapyPre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays. CT scans, the barium swallow, the endoscopy and endoscopic ultrasound reports and PET scans should be used for tumor definition. Post-Operative Radiotherapy: In the event that gross residual disease is left behind at the time of surgery or the patient is found to have a microscopic positive deep or gastric margin following surgery, additional treatment with radiation therapy will be considered. | Radiation | Bevacizumab |
| EsophagectomyTranshiatal esophagectomy performed on approximately Day #57 (6 weeks after last dose of bevacizumab.) | Procedure or surgery | Bevacizumab |
Primary outcome
Disease Free Survival Time
Time frame: 5 years
The primary outcome that will be measured is the length of time that patients are alive without recurrence of cancer following this therapy.
2 secondary outcomes
The Number of Patients Cancer Free at the Time of Surgery
Time frame: 1 year
The Proportion of Toxicities Experienced by Participants
Time frame: Every three weeks for one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Loco-regional Esophageal Cancer
Not yet recruitingPhase 2
Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors
Recurrent Cancer, Prostate Cancer
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.
Susan Urba, MD principal investigator
University of Michigan Rogel Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, Paclitaxel and Cisplatin in people with Loco-regional Esophageal Cancer, run by University of Michigan Rogel Cancer Center.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 12 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disease Free Survival Time (time frame: 5 years). 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 26 May 2016.