Pancreatic CancerPhase 2NCT00557492
Efficacy of Neoadjuvant Chemoradiation for Potentially Resectable Pancreas Cancer
A Phase 2 study testing Avastin (bevacizumab), Gemzar (Gemcitabine) and external beam radiotherapy in people with Pancreatic Cancer, run by Amer Zureikat at 1 site in United States.
Trial summary
This study is to determine the efficacy of bevacizumab and gemcitabine in combination with radiation therapy in the preoperative treatment of potentially-resectable subjects with pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Avastin (bevacizumab), Gemzar (Gemcitabine) and external beam radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Dec 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic or cytologic proof of pancreatic adenocarcinoma.
- Subjects with biopsy-proven adenocarcinoma of the pancreas which is potentially resectable by preoperative imaging. Subjects will be considered potentially resectable using criteria defined by Pisters (Pisters et al., 2001):
- if imaging detects no evidence of extrapancreatic disease;
- no evidence of tumor extension to the superior mesenteric artery (SMA) or celiac axis (intact fat plane between the tumor and the adjacent visceral artery),
- patent superior mesenteric-portal vein confluence
- no encasement of portal or superior mesenteric vein.
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- Karnofsky performance status ≥ 80.
- No active second malignancy except for basal cell carcinoma of the skin
- Normal renal, hepatic, and hematologic function at the time of enrollment as evidenced by:
- Serum creatinine level ≤1.6 mg/dl ( Calculated Creat clearance >50)
- Serum total bilirubin level ≤1.5 X ULN
- Urine protein excretion ≤ 1+ by urine dipstick
- White blood cell count ≥ 3.5x109/ml per ml and platelet count ≥ 100x109 per ml
- Age >18 years.
- Children are excluded because of toxic effects of bevacizumab and gemcitabine on growth and development during preclinical studies.
- For subjects with obstructive jaundice, the biliary tract must be drained with a temporary plastic or a short permanent metallic biliary stent.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Disease-Specific Exclusions
- Subjects who have received chemotherapy within 12 months prior to study entry.
- Prior use of radiotherapy or investigational agents for pancreatic cancer.
- Subjects who have undergone laparotomy for pancreas cancer within 6 weeks
- Any evidence of metastasis to distant organs (liver, lung, peritoneum).
- Symptomatic or endoscopic evidence of gastric outlet obstruction
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- Endoscopic findings suggesting tumor erosion into the gastrointestinal mucosa.
- Concurrent malignancies with evidence of active or measurable disease except basal cell carcinoma of the skin.
- General Medical Exclusions
- Inability to adhere to study and/or follow-up procedures
- History of allergic reactions or hypersensitivity to the study drugs (bevacizumab, gemcitabine, and proton pump inhibitors).
- Other concurrent experimental therapy.
- Because subjects with immune deficiency are at increased risk for lethal infections when treated with marrow-suppressive therapy, HIV-positive subjects receiving combination anti-retroviral therapy are excluded from the study.
- Bevacizumab-Specific Exclusions
- Subjects who have had recent surgery (prior 6 weeks)
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
- Subjects with the following co-morbid medical conditions:
- History of myocardial infarction or unstable angina within 12 months prior to study enrollment.
- Ascites
- Pregnancy/lactation - The effects of the study drugs on the developing human fetus are unknown. For this reason and because bevacizumab, gemcitabine, and radiation therapy used in this trial are known to be teratogenic in animal studies, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of study entry until 6 months after the completion of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A serum pregnancy test for those females of childbearing potential must be done prior to their receiving study drugs. Due to the combined effects of chemotherapy and radiation, breastfeeding is not allowed for 6 months after the completion of study participation.
- Regular aspirin use > 325 mg per day
- Regular NSAID use
- Bleeding diathesis, coagulopathy, need for full-dose anticoagulation or INR > 1.5
- Known central nervous system metastasis
- Previous cerebrovascular accident, transient ischemic attack, or seizure (within 6 months)
- Serious non-healing wound, ulcer, or bone fracture
- History of abdominal fistula, gastrointestinal perforation, diverticulitis, or intra-abdominal abscess within 6 months prior to study enrollment.
- Recent hemoptysis,
- Uncontrolled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) grade 2 or greater congestive heart failure (see Appendix I)
- Prior deep venous thrombosis or pulmonary embolism
- Urine protein excretion 2+ or ≥ 1 g per 24 hours
- Peripheral vascular disease such as lower extremity claudication and rest pain or prior lower extremity vascular surgery for arterial insufficiency
- Dyspnea requiring supplemental oxygen
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Centers
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Phase II Study of the Anti-Vascular Endothelial Growth Factor (α-VEGF) Monoclonal Antibody Bevacizumab in Combination With Fixed Dose Rate (FDR) Gemcitabine and Rapid-Fractionation Radiotherapy in the Pre-operative Treatment of Potentially- Resectable Pancreatic Adenocarcinoma
This study is to determine the efficacy of bevacizumab and gemcitabine in combination with radiation therapy in the preoperative treatment of potentially-resectable subjects with pancreatic cancer.
Read the detailed description
This is a 2 stage phase II study of bevacizumab (10 mg/kg) and fixed dose rate (FDR) gemcitabine (1500 mg/m2 at 10 mg/kg/min) in combination with sequential rapid fractionation radiotherapy (30 Gy total) in the preoperative treatment of potentially-resectable subjects with adenocarcinoma of the pancreas. The purpose of this study is to determine the rate of margin negative surgical resection (R0 resection rate) and the rate of complete pathological response in patients with resected pancreas cancer. The overall goal of this study is to determine the merit of this novel regimen for further study in a Phase III trial examining time to progression and overall survival. Based on the need for 48 evaluable subjects to evaluate the primary endpoints, the study will be opened with a target accrual of 60 subjects given an expected 20% rate of attrition observed in prior studies of subjects with pancreas cancer at UPCI.
- Conditions
- Pancreatic Cancer
- Being tested
- Avastin (bevacizumab), Gemzar (Gemcitabine), external beam radiotherapy
- Keywords
- pancreas, pancreatic, cancer, resectable
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avastin (bevacizumab)Drug
10 mg/kg, days 1, 15, 29 and 43
Gemzar (Gemcitabine)Drug
On days 1, 15, and 29, subjects will receive gemcitabine 1500 mg/m2 IV over 150 minutes at the fixed-dose rate (10 mg/m2/min).
external beam radiotherapyRadiation
3 Gy/fraction utilizing a 95% isodose field over 10 consecutive weekdays, Monday to Friday, for a total of 30 Gy
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Intervention: Drug: Avastin (bevacizumab) 10 mg/kg, days 1, 15, 29 and 43
Intervention: Drug: Gemzar (Gemcitabine) On days 1, 15, and 29, subjects will receive gemcitabine 1500 mg/m2 IV over 150 minutes at the fixed-dose rate (10 mg/m2/min).
Intervention:Radiation: external beam radiotherapy 3 Gy/fraction utilizing a 95% isodose field over 10 consecutive weekdays, Monday to Friday, for a total of 30 Gy Receives: Drug: Avastin (bevacizumab); Drug: Gemzar (Gemcitabine); Radiation: external beam radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Margin Negative Surgical Resection (R0 Resection Rate)
Number of participants who underwent laparoscopy and pancreatic resections that were margin negative/total number of participants who underwent laparoscopy and pancreatic resections.
Measured: Up to 48 months
Rate of Pathologic Complete Response (pCR)
Rate of pathologic complete response (pCR) is no residual invasive tumor, in situ carcinoma can be present, and no residual lymph node metastasis. Rate of pCR is the number of participants who underwent laparoscopy and pancreatic resections that experienced complete pathologic response/total number of participants who underwent laparoscopy and pancreatic resections.
Measured: Up to 48 months
Secondary outcomes (5)
Overall Survival (OS)
Measured: Up to 48 months
Progression-free Survival (PFS)
Measured: Up to 48 months
Rate of Surgical Resection
Number of participants that underwent resection / per the total number of evaluable participants
Measured: Up to 48 months
Radiographic Tumor Response
CT scans evaluated for response using Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Up to 48 months
Ca 19-9 Level (in Serum) - Biomarker Response
Percentage decrease in Ca 19-9 level (in serum)
Measured: Baseline and up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startDec 2006
- Primary completionMar 2012
- Study completionDec 2016
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 Pancreatic CancerStudies of the same condition, open and under way.
- 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amer Zureikat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amer Zureikat, University of Pittsburgh
- Investigators
- Herbert J. Zeh, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557492
- Sponsor's protocol ID
- 06-035
- Status last verified
- Aug 2018
- First submitted
- 13 Nov 2007
- Last updated
- 25 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Anti-Vascular Endothelial Growth Factor (α-VEGF) Monoclonal Antibody Bevacizumab in Combination With Fixed Dose Rate (FDR) Gemcitabine and Rapid-Fractionation Radiotherapy in the Pre-operative Treatment of Potentially- Resectable Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00557492
- Acronym / sponsor ID
- 06-035
- Conditions
- Pancreatic Cancer
- Keywords
- pancreas, pancreatic, cancer, resectable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Amer ZureikatUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 Nov 2007 (estimated)
- Results
- Posted 12 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to determine the efficacy of bevacizumab and gemcitabine in combination with radiation therapy in the preoperative treatment of potentially-resectable subjects with pancreatic cancer.
Detailed description
This is a 2 stage phase II study of bevacizumab (10 mg/kg) and fixed dose rate (FDR) gemcitabine (1500 mg/m2 at 10 mg/kg/min) in combination with sequential rapid fractionation radiotherapy (30 Gy total) in the preoperative treatment of potentially-resectable subjects with adenocarcinoma of the pancreas. The purpose of this study is to determine the rate of margin negative surgical resection (R0 resection rate) and the rate of complete pathological response in patients with resected pancreas cancer. The overall goal of this study is to determine the merit of this novel regimen for further study in a Phase III trial examining time to progression and overall survival. Based on the need for 48 evaluable subjects to evaluate the primary endpoints, the study will be opened with a target accrual of 60 subjects given an expected 20% rate of attrition observed in prior studies of subjects with pancreas cancer at UPCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Avastin (bevacizumab), Drug: Gemzar (Gemcitabine), Radiation: external beam radiotherapyIntervention: Drug: Avastin (bevacizumab) 10 mg/kg, days 1, 15, 29 and 43 Intervention: Drug: Gemzar (Gemcitabine) On days 1, 15, and 29, subjects will receive gemcitabine 1500 mg/m2 IV over 150 minutes at the fixed-dose rate (10 mg/m2/min). Intervention:Radiation: external beam radiotherapy 3 Gy/fraction utilizing a 95% isodose field over 10 consecutive weekdays, Monday to Friday, for a total of 30 Gy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologic or cytologic proof of pancreatic adenocarcinoma.
- Subjects with biopsy-proven adenocarcinoma of the pancreas which is potentially resectable by preoperative imaging. Subjects will be considered potentially resectable using criteria defined by Pisters (Pisters et al., 2001):
- if imaging detects no evidence of extrapancreatic disease;
- no evidence of tumor extension to the superior mesenteric artery (SMA) or celiac axis (intact fat plane between the tumor and the adjacent visceral artery),
- patent superior mesenteric-portal vein confluence
Key exclusion criteria (35 listed)
- Disease-Specific Exclusions
- Subjects who have received chemotherapy within 12 months prior to study entry.
- Prior use of radiotherapy or investigational agents for pancreatic cancer.
- Subjects who have undergone laparotomy for pancreas cancer within 6 weeks
- Any evidence of metastasis to distant organs (liver, lung, peritoneum).
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 |
|---|---|---|
| Avastin (bevacizumab)10 mg/kg, days 1, 15, 29 and 43 | Drug | Single Arm |
| Gemzar (Gemcitabine)On days 1, 15, and 29, subjects will receive gemcitabine 1500 mg/m2 IV over 150 minutes at the fixed-dose rate (10 mg/m2/min). | Drug | Single Arm |
| external beam radiotherapy3 Gy/fraction utilizing a 95% isodose field over 10 consecutive weekdays, Monday to Friday, for a total of 30 Gy | Radiation | Single Arm |
Primary outcome
Rate of Margin Negative Surgical Resection (R0 Resection Rate)
Time frame: Up to 48 months
Number of participants who underwent laparoscopy and pancreatic resections that were margin negative/total number of participants who underwent laparoscopy and pancreatic resections.
Rate of Pathologic Complete Response (pCR)
Time frame: Up to 48 months
Rate of pathologic complete response (pCR) is no residual invasive tumor, in situ carcinoma can be present, and no residual lymph node metastasis. Rate of pCR is the number of participants who underwent laparoscopy and pancreatic resections that experienced complete pathologic response/total number of participants who underwent laparoscopy and pancreatic resections.
5 secondary outcomes
Overall Survival (OS)
Time frame: Up to 48 months
Progression-free Survival (PFS)
Time frame: Up to 48 months
Rate of Surgical Resection
Time frame: Up to 48 months
Radiographic Tumor Response
Time frame: Up to 48 months
Ca 19-9 Level (in Serum) - Biomarker Response
Time frame: Baseline and up to 48 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Herbert J. Zeh, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avastin (bevacizumab), Gemzar (Gemcitabine) and external beam radiotherapy in people with Pancreatic Cancer, run by Amer Zureikat 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 17 inclusion and 35 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 25 Sep 2018. 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 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 Dec 2016). 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?
Rate of Margin Negative Surgical Resection (R0 Resection Rate) (time frame: Up to 48 months). The study lists 2 primary outcomes in all. 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 25 Sep 2018.