Adenocarcinoma of the PancreasPhase 2NCT00253526
Gemcitabine Hydrochloride With or Without Bevacizumab in Treating Patients Who Are Undergoing Surgery for Pancreatic Cancer
A Phase 2 study testing bevacizumab, gemcitabine hydrochloride and adjuvant therapy in people with Adenocarcinoma of the Pancreas and Recurrent Pancreatic Cancer, run by National Cancer Institute (NCI).
Trial summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage I Pancreatic Cancer
- What is being tested?
- bevacizumab, gemcitabine hydrochloride and adjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- No evidence of distant metastasis on laparoscopy
- No superior mesenteric artery or thrombosed superior mesenteric vein involvement
- Superior mesenteric vein or portal vein involvement allowed
- Evidence of a pancreatic mass by radiographic or endoscopic examination
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 2,500/mm^3
- Absolute neutrophil count ≥ 1,250/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Hepatitis B surface antigen negative
- Hepatitis C virus negative
- No history of hepatic cirrhosis
Renal
- Creatinine ≤ 2.0 mg/dL
- Proteinuria negative or trace by urinalysis OR
- Protein < 1 g on 24 hr urine collection
- No active gross hematuria
Cardiovascular
- No severe congestive heart failure
- No active ischemic heart disease
- No ischemic changes on a cardiac thallium stress test
- No uncontrolled hypertension (i.e., blood pressure ≤ 150/100 mm Hg despite antihypertensive therapy)
- No active coagulation disorder
Pulmonary
- No active gross hemoptysis
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during the adjuvant therapy part of trial
- HIV negative
- No active infection
- No wound healing problem from recent invasive procedure
- No significant history of medical illness that would preclude patient from undergoing an operative procedure
- No other malignancy requiring systemic therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Recovered from prior immunotherapy for pancreatic cancer
- No prior bevacizumab
Chemotherapy
- Recovered from prior chemotherapy for pancreatic cancer
- No prior gemcitabine hydrochloride
Endocrine therapy
- Recovered from prior hormonal therapy for pancreatic cancer
Radiotherapy
- Recovered from prior radiotherapy for pancreatic cancer
- No prior radiotherapy to the pancreas
Surgery
- No prior definitive resection of the primary pancreatic tumor
- Prior surgery, other than resection of the primary tumor, allowed
Other
- More than 3 weeks since prior systemic therapy for this cancer
- No concurrent therapeutic anticoagulation causing elevated PT or PTT
About this study
Official title: Phase II Randomized Study of Surgical Resection and Adjuvant Gemcitabine Hydrochloride With Versus Without Bevacizumab in Patients With Adenocarcinoma of the Pancreas
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells an help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Giving gemcitabine hydrochloride together with bevacizumab after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying gemcitabine hydrochloride and bevacizumab to see how well they work compared to gemcitabine hydrochloride alone in treating patients who are undergoing surgery for pancreatic cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the disease-free interval in patients with adenocarcinoma of the pancreas treated with surgical resection followed by adjuvant gemcitabine hydrochloride with vs without bevacizumab.
Secondary
- Compare overall survival in patients treated with these regimens.
- Evaluate tumor gene expression profiles and levels of tumor angiogenesis markers to establish prognostic indicators for response in patients treated with these regimens.
OUTLINE: This is a randomized, controlled study.
All patients undergo surgical resection for the pancreatic tumor. Within 4-8 weeks after surgery, patients are stratified according to projected 2-year survival (≤ 5% vs > 5% and ≤ 33% vs > 33%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses. Patients then receive bevacizumab IV alone every 2 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.
- Conditions
- Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage I Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer
- Being tested
- bevacizumab, gemcitabine hydrochloride, adjuvant therapy, anti-cytokine therapy, antiangiogenesis therapy
- 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
adjuvant therapyProcedure or surgery
anti-cytokine therapyProcedure or surgery
antiangiogenesis therapyProcedure or surgery
antibody therapyProcedure or surgery
biological therapyProcedure or surgery
chemotherapyProcedure or surgery
conventional surgeryProcedure or surgery
growth factor antagonist therapyProcedure or surgery
monoclonal antibody therapyProcedure or surgery
surgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the PancreasStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Richard E. Royal, MD, FACS, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253526
- Sponsor's protocol ID
- CDR0000448825
- Other IDs
- NCI-05-C-0158, NCI-P6503
- Status last verified
- Dec 2006
- First submitted
- 11 Nov 2005
- Last updated
- 28 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study of Surgical Resection and Adjuvant Gemcitabine Hydrochloride With Versus Without Bevacizumab in Patients With Adenocarcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT00253526
- Acronym / sponsor ID
- CDR0000448825
- Conditions
- Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage I Pancreatic Cancer, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- First posted
- 15 Nov 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.
RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells an help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Giving gemcitabine hydrochloride together with bevacizumab after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying gemcitabine hydrochloride and bevacizumab to see how well they work compared to gemcitabine hydrochloride alone in treating patients who are undergoing surgery for pancreatic cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the disease-free interval in patients with adenocarcinoma of the pancreas treated with surgical resection followed by adjuvant gemcitabine hydrochloride with vs without bevacizumab.
Secondary
- Compare overall survival in patients treated with these regimens.
- Evaluate tumor gene expression profiles and levels of tumor angiogenesis markers to establish prognostic indicators for response in patients treated with these regimens.
OUTLINE: This is a randomized, controlled study.
All patients undergo surgical resection for the pancreatic tumor. Within 4-8 weeks after surgery, patients are stratified according to projected 2-year survival (≤ 5% vs > 5% and ≤ 33% vs > 33%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on days 1, 8, and 15, and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses. Patients then receive bevacizumab IV alone every 2 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| bevacizumab | Drug | – |
| gemcitabine hydrochloride | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| anti-cytokine therapy | Procedure or surgery | – |
| antiangiogenesis therapy | Procedure or surgery | – |
| antibody therapy | Procedure or surgery | – |
| biological therapy | Procedure or surgery | – |
| chemotherapy | Procedure or surgery | – |
| conventional surgery | Procedure or surgery | – |
| growth factor antagonist therapy | Procedure or surgery | – |
| monoclonal antibody therapy | Procedure or surgery | – |
| surgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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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.
Richard E. Royal, MD, FACS principal investigator
National Cancer Institute (NCI)
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab, gemcitabine hydrochloride and adjuvant therapy in people with Adenocarcinoma of the Pancreas and Recurrent Pancreatic Cancer, run by National Cancer Institute (NCI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 28 Apr 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 28 Apr 2015.