Status:
COMPLETED
Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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. Be...
Detailed Description
OBJECTIVES: Primary * Determine progression-free survival of patients with metastatic or unresectable adenocarcinoma of the pancreas treated with gemcitabine, capecitabine, and bevacizumab. Seconda...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00100815
Start Date
August 1 2004
Last Update
December 24 2015
Active Locations (2)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
2
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-1714