Clinical trialPhase 2Terminated
Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Phase II and Coagulation Study of rhuMAb-VEGF With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma
- Outcome
- Stopped earlyStopped accordining to early stopping rule for futility (Efficacy or futility)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- October 2003
- Expected end
- April 2009
- Enrollment
- 32 participants
- Sites
- 1
- Primary outcomes
- Progression-free Survival
- Sponsor
- Other
- Results posted
- 2021-03-05
- Last update
- 5 March 2021
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Progression-free Survival [4 months]. Median, days (Full Range). rhuMAB-VEGF (n=16): 43 (28 to 120); rhuMAB-VEGF and Docetaxel (n=16): 48 (28 to 120).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Objective Response Rate [56 days]. Number, participants. rhuMAB-VEGF (n=16): 0; rhuMAB-VEGF and Docetaxel (n=16): 0.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [From date of registration until the date of death, assessed up to 5 years]. Median, days (Full Range). rhuMAB-VEGF (n=16): 165 (28 to 480); rhuMAB-VEGF and Docetaxel (n=16): 125 (28 to 480).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Thromboembolic Events [93 days]. Number, participants. rhuMAB-VEGF (n=16): 3; rhuMAB-VEGF and Docetaxel (n=16): 2.
Papers 1
- Registry-listed results paperPhase II and coagulation cascade biomarker study of bevacizumab with or without docetaxel in patients with previously t… DOI 10.1097/coc.0b013e3181d2734a↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.