Clinical trial · Interventional
Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Pancreatic Cancer That Can Be Removed By Surgery
A Pilot Study of Bevacizumab Based Peri-Operative Therapy for Operable Pancreatic Adenocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn due to no accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, 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 and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor cells. PURPOSE: This clinical trial is studying the side effects and how well giving gemcitabine and capecitabine together with bevacizumab works in treating patients with pancreatic cancer that can be removed by surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| bevacizumab | Biological | Bevacizumab | ALIAS |
| capecitabine | Drug | Capecitabine | ALIAS |
| computed tomography | Procedure | — | UNRESOLVED |
| flow cytometry | Other | — | UNRESOLVED |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Feasibility and safety
- measure
- Margin status after pancreatic resection
Secondary outcomes (8)
- measure
- Proportion of patients with positive resection margins, including microscopic (R1) or gross (R2) positive resection margins
- measure
- Median survival
- measure
- Time to recurrence
- measure
- Overall survival
- measure
- Number of circulating endothelial precursor cells (CEC) and their VEGFR expression as measured by flow cytometry at baseline and after the start of neoadjuvant therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed pancreatic adenocarcinoma
* Resectable disease (i.e., stage I or II disease)
* No unresectable (i.e., locally advanced) disease
* No tumor invasion into the stomach or duodenum
* No CNS, brain, or systemic metastases
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* WBC \> 3,000/μL
* ANC \> 1,500/μL
* Platelet count \> 100,000/μL
* Total bilirubin \< 2 mg/dL
* AST or ALT \< 2.5 times upper limit of normal (ULN)
* Creatinine \< 1.5 mg/dL
* Creatinine clearance ≥ 50 mL/min
* Urine protein:creatinine ratio \< 1.0
* Hemoglobin ≥ 9 g/dL (transfusion, epoetin alfa, or darbepoetin allowed)
* INR \< 1.5 times ULN (except in patients receiving full-dose warfarin)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled hypertension
* No unstable angina
* No New York Heart Association class II-IV congestive heart failure
* No myocardial infarction or stroke within the past 6 months
* No clinically significant peripheral vascular disease
* No evidence of bleeding diathesis or coagulopathy
* No significant traumatic injury within the past 28 days
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* No esophageal or gastric varices
* No serious nonhealing wound, ulcer, or bone fracture
PRIOR CONCURRENT THERAPY:
* No prior therapy for pancreatic cancer
* More than 4 weeks since prior and no concurrent participation in another experimental drug study
* More than 28 days since prior major surgical procedure or open biopsy
* More than 7 days since prior minor surgical procedure (e.g., fine-needle aspiration or core biopsy)References
Publications (0)
Data not yet available