Clinical trial · Interventional
Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer
Multicenter, Open Label, Phase II Clinical Study of Gemcitabine, Capecitabine and Avastin in Pancreatic Cancer
NCT00100815CI-TRIAL-00020311completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine and capecitabine together with bevacizumab works in treating patients with metastatic or unresectable pancreatic cancer.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| capecitabine | Drug | Capecitabine | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- every 2-4 months for 1 year and then every 6 months for 5 years
- description
- Progressive Disease is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI 92(3):205-216, 2000\], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Secondary outcomes (4)
- measure
- Percentage of Participants With Grades 3-5 Treatment Related Toxicities
- timeFrame
- Subjects were evaluated for adverse events at each study visit for the duration of their participation in the study, up to 5 years
- description
- Grade 3, 4 or 5 toxicity rate
- measure
- Percentage of Participants With Improved Quality of Life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the pancreas meeting 1 of the following criteria: * Newly diagnosed or previously treated metastatic disease * Unresectable disease * No CNS or brain metastases PATIENT CHARACTERISTICS: Age * Over 18 Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * WBC \> 3,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed) * No evidence of bleeding diathesis or coagulopathy Hepatic * Bilirubin \< 2 mg/dL * AST or ALT \< 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * INR \< 1.5 (except for patients receiving full-dose warfarin) Renal * Creatinine \< 1.5 mg/dL * No proteinuria OR * Urine protein \< 500 mg by 24-hour urine collection * No clinically significant impairment of renal function Cardiovascular * No uncontrolled hypertension (blood pressure \> 160/110 mm Hg on medication) * No New York Heart Association class II-IV congestive heart failure * No unstable symptomatic arrhythmia requiring medication * Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed * No clinically significant grade II-IV peripheral vascular disease * No arterial thromboembolic event within the past 6 months, including any of the following: * Transient ischemic attack * Cerebrovascular accident * Unstable angina * Myocardial infarction Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other serious systemic disease * No significant traumatic injury within the past 28 days * No serious non-healing wound, ulcer, or bone fracture * No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * More than 28 days since prior major surgery or open biopsy * More than 7 days since prior fine needle aspirations or core biopsies * No concurrent major surgery Other * More than 4 weeks since prior and no concurrent participation in any other experimental drug study * More than 12 months since prior adjuvant therapy * No prior systemic therapy for metastatic disease
References
Publications (1)
- RESULTJavle M, Yu J, Garrett C, Pande A, Kuvshinoff B, Litwin A, Phelan J 3rd, Gibbs J, Iyer R. Bevacizumab combined with gemcitabine and capecitabine for advanced pancreatic cancer: a phase II study. Br J Cancer. 2009 Jun 16;100(12):1842-5. doi: 10.1038/sj.bjc.6605099. Epub 2009 Jun 2. PMID 19491904