Status:
COMPLETED
Gemcitabine, Cisplatin, and Bevacizumab in Treating Patients With Metastatic Pancreatic Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoc...
Detailed Description
OBJECTIVES: Primary * Determine time to disease progression in patients with previously untreated metastatic adenocarcinoma of the pancreas treated with gemcitabine, cisplatin, and bevacizumab. * De...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Must have documented extrapancreatic metastases
- Radiographically measurable disease is not required
- Previously untreated disease
- No CNS or brain metastases
- PATIENT CHARACTERISTICS:
- Age
- 18 and over
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa \[Epogen®\] support allowed)
- No evidence of bleeding diathesis or coagulopathy
- Hepatic
- INR ≤ 1.5 (except for patients receiving full-dose warfarin)
- Bilirubin ≤ 2.0 mg/dL
- AST or ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Renal
- Creatinine ≤ 2.0 mg/dL
- Urine protein:creatinine ratio ≤ 1
- Cardiovascular
- No New York Heart Association class II-IV congestive heart failure
- No myocardial infarction or stroke within the past 6 months
- No uncontrolled hypertension (i.e., blood pressure \> 160/110 mm Hg despite antihypertensive therapy)
- No unstable angina
- No unstable symptomatic arrhythmia requiring medication
- Patients with chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) are eligible
- No peripheral vascular disease ≥ grade 2
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No significant traumatic injury within the past 28 days
- No serious non-healing wound, ulcer, or bone fracture
- No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- No other serious systemic disease
- No history of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would preclude study treatment
- 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
- No prior therapy, including systemic or investigational therapy, for locally advanced or metastatic pancreatic cancer
- Treatment given in the adjuvant setting (e.g., radiotherapy and/or chemotherapy, given either concurrently or systemically) is not considered prior therapy provided progressive disease occurred \> 6 months after completion of prior treatment
- Concurrent continuation of therapeutic doses of warfarin or low-molecular weight heparin allowed for pulmonary embolism, deep vein thrombosis, atrial fibrillation, or other clinical indications provided patients has been on a stable dose for ≥ 28 days with no further clotting or bleeding complications
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00126633
Start Date
April 1 2004
End Date
October 1 2008
Last Update
September 17 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115