Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the pancreas Metastatic disease Unidimensionally measurable disease outside of the pancreas At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Must have received 1, and only 1, prior gemcitabine-containing regimen for metastatic disease unless disease has recurred within 6 months after treatment with neoadjuvant or adjuvant gemcitabine-containing therapy No brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL (transfusion allowed) No bleeding diathesis or coagulopathy Hepatic Bilirubin no greater than upper limit of normal (ULN) AST and ALT no greater than 1.5 times ULN INR no greater than ULN PTT no greater than ULN Renal Creatinine no greater than 2.0 mg/dL No clinically significant renal impairment Urine protein:creatinine ratio ≥ 1.0 Cardiovascular No prior myocardial infarction No prior stroke No clinically significant cardiovascular disease No uncontrolled hypertension (i.e., blood pressure greater than 160/110 mm Hg on medication) No unstable angina No New York Heart Association class II-IV congestive heart failure No serious cardiac dysrhythmia requiring medication No peripheral vascular disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history or evidence of CNS disease (e.g, primary brain tumor or seizures not controlled with standard medical therapy) No other medical condition that would preclude study participation No psychiatric condition that would preclude study participation No other prior or concurrent malignancy that would preclude study participation No significant traumatic injury within the past 28 days No serious, nonhealing wound, ulcer, or bone fracture PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent prophylactic granulocyte or platelet growth factors Chemotherapy See Disease Characteristics More than 4 weeks since prior chemotherapy Endocrine therapy Not specified Radiotherapy At least 4 weeks since prior radiotherapy Surgery More than 7 days since prior fine needle aspirations or core biopsies More than 28 days since prior surgery (except closed biopsy or access port placement) More than 28 days since prior open biopsy No concurrent surgery Other More than 4 weeks since prior experimental drug study participation More than 4 weeks since prior investigational drugs No other concurrent experimental drug study participation
Sites / Locations
- Fox Chase Cancer Center - Philadelphia
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
rhuMAB-VEGF
rhuMAB-VEGF and Docetaxel
bevacizumab 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks until disease progression, unacceptable toxicity or patient preference.
rhuMAB-VEGF,bevacizumab: 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks docetaxel, Taxotere: 35 mg/m2 given intravenously over 1 hour on days 1, 8, and 15 of each 28 day cycle. Treatment continued until evidence of disease progression, unacceptable toxicity, or patient preference.