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

Primary Purpose

Pancreatic Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rhuMAB-VEGF
docetaxel
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Arm Label

rhuMAB-VEGF

rhuMAB-VEGF and Docetaxel

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression-free Survival

Secondary Outcome Measures

Objective Response Rate
Overall Survival
Number of Participants With Thromboembolic Events

Full Information

First Posted
August 6, 2003
Last Updated
February 15, 2021
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00066677
Brief Title
Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Official Title
Phase II and Coagulation Study of rhuMAb-VEGF With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Stopped accordining to early stopping rule for futility
Study Start Date
October 2003 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rhuMAB-VEGF
Arm Type
Experimental
Arm Description
bevacizumab 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks until disease progression, unacceptable toxicity or patient preference.
Arm Title
rhuMAB-VEGF and Docetaxel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
rhuMAB-VEGF
Intervention Type
Drug
Intervention Name(s)
docetaxel
Primary Outcome Measure Information:
Title
Progression-free Survival
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Objective Response Rate
Time Frame
56 days
Title
Overall Survival
Time Frame
From date of registration until the date of death, assessed up to 5 years
Title
Number of Participants With Thromboembolic Events
Time Frame
93 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven J. Cohen, MD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20458210
Citation
Astsaturov IA, Meropol NJ, Alpaugh RK, Burtness BA, Cheng JD, McLaughlin S, Rogatko A, Xu Z, Watson JC, Weiner LM, Cohen SJ. Phase II and coagulation cascade biomarker study of bevacizumab with or without docetaxel in patients with previously treated metastatic pancreatic adenocarcinoma. Am J Clin Oncol. 2011 Feb;34(1):70-5. doi: 10.1097/COC.0b013e3181d2734a.
Results Reference
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Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer

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