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

Phase 2

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Drug: rhuMAB-VEGF; Drug: docetaxel

• Registration Number: NCT00066677
• Lead Sponsor: Fox Chase Cancer Center

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.

Study Timeline

• Study First Submitted: 2003-08-06
• Study First Submitted QC: 2003-08-06
• Study First Posted: 2003-08-07
• Study Start: 2003-10
• Primary Completion: 2008-11
• Study Completion: 2009-04
• Results First Submitted: 2013-08-16
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-15
• Last Update Submitted: 2021-02-15
• Results First Posted: 2021-03-05
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rhuMAB-VEGF	rhuMAB-VEGF	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 and Docetaxel	docetaxel	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.
rhuMAB-VEGF and Docetaxel	rhuMAB-VEGF	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.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	4 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fox Chase Cancer Center - Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States