Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer

Study Overview
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Brief Summary
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RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with docetaxel may kill more tumor cells. PURPOSE: This randomized phase II trial is studying bevacizumab and docetaxel to see how well they work compared to bevacizumab alone in treating patients with metastatic pancreatic cancer.

Detailed Description
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OBJECTIVES: Determine the progression-free survival of patients with previously treated metastatic pancreatic adenocarcinoma treated with bevacizumab with or without docetaxel. Determine the objective response rate and overall survival of patients treated with these regimens. Determine the incidence of thromboembolic events in patients treated with these regimens. OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV over 1 hour on days 1, 8, and 15. Arm II: Patients receive bevacizumab as in arm I. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this study.

Official Title
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Phase II and Coagulation Study of rhuMAb-VEGF With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: rhuMAB-VEGF
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rhuMAB-VEGF<br>bevacizumab 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks until disease progression, unacceptable toxicity or patient preference. | Drug: rhuMAB-VEGF<br> <br> |
| Experimental: rhuMAB-VEGF and Docetaxel<br>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. | Drug: rhuMAB-VEGF<br> <br> Drug: docetaxel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | 56 days | 
| Overall Survival |  | From date of registration until the date of death, assessed up to 5 years | 
| Number of Participants With Thromboembolic Events |  | 93 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage IV pancreatic cancer