Clinical trial · Interventional
Gemcitabine Hydrochloride With or Without Bevacizumab in Treating Patients Who Are Undergoing Surgery for Pancreatic Cancer
Phase II Randomized Study of Surgical Resection and Adjuvant Gemcitabine Hydrochloride With Versus Without Bevacizumab in Patients With Adenocarcinoma of the Pancreas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Pancreas | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (12)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| antiangiogenesis therapy | Procedure | — | UNRESOLVED |
| antibody therapy | Procedure | — | UNRESOLVED |
| anti-cytokine therapy | Procedure | — | UNRESOLVED |
| bevacizumab | Drug | Bevacizumab | ALIAS |
| biological therapy | Procedure | — | UNRESOLVED |
| chemotherapy | Procedure | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| gemcitabine hydrochloride | Drug |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available