Phase 2
N=50
Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00100815 ↗Enrolled (actual)
50
Serious AEs
54.0%
Results posted
Dec 2015
Primary outcome: Primary: Progression-free Survival — 5.7 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bevacizumab (Biological); capecitabine (Drug); gemcitabine hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Roswell Park Cancer Institute
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
5.7 | — |
| SECONDARY Percentage of Participants With Grades 3-5 Treatment Related Toxicities |
70 | — |
| SECONDARY Percentage of Participants With Improved Quality of Life |
56.0 | — |
| SECONDARY Clinical Response |
22.0 | — |
| SECONDARY Overall Survival |
9.8 | — |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00100815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.