A Phase 2 interventional study of rhuMAB-VEGF and docetaxel in Pancreatic Cancer, sponsored by Fox Chase Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-05.
Sponsored by Fox Chase Cancer Center · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this study.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 32 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Fox Chase Cancer Center is the lead sponsor of 211 studies on the registry; 30 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 8 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the pancreas
Unidimensionally measurable disease outside of the pancreas
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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
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 · Drug: docetaxel
Progression-free Survival
Time frame: 4 months
Objective Response Rate
Time frame: 56 days
Overall Survival
Time frame: From date of registration until the date of death, assessed up to 5 years
Number of Participants With Thromboembolic Events
Time frame: 93 days
Study was conducted at Fox Chase Cancer Center between October 2004 and December 20006.
| Milestone | rhuMAB-VEGF | rhuMAB-VEGF and Docetaxel |
|---|---|---|
| Started | 16 | 16 |
| Completed | 16 | 16 |
| Not completed | 0 | 0 |
| days | rhuMAB-VEGF | rhuMAB-VEGF and Docetaxel |
|---|---|---|
| Progression-free Survival | 43 (28 to 120) | 48 (28 to 120) |
| participants | rhuMAB-VEGF | rhuMAB-VEGF and Docetaxel |
|---|---|---|
| Objective Response Rate | 0 | 0 |
| days | rhuMAB-VEGF | rhuMAB-VEGF and Docetaxel |
|---|---|---|
| Overall Survival | 165 (28 to 480) | 125 (28 to 480) |
| participants | rhuMAB-VEGF | rhuMAB-VEGF and Docetaxel |
|---|---|---|
| Number of Participants With Thromboembolic Events | 3 | 2 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| rhuMAB-VEGF | 16/16 (100%) | 13/16 (81.3%) | 0/16 (0%) |
| rhuMAB-VEGF and Docetaxel | 16/16 (100%) | 15/16 (93.8%) | 0/16 (0%) |
| Event | rhuMAB-VEGF | rhuMAB-VEGF and Docetaxel |
|---|---|---|
| FatigueGeneral disorders | 13/16 | 15/16 |
| AnemiaBlood and lymphatic system disorders | 12/16 | 15/16 |
| AnorexiaGeneral disorders | 10/16 | 11/16 |
| LeukopeniaBlood and lymphatic system disorders | 5/16 | 11/16 |
| HypoalbuminemiaGeneral disorders | 9/16 | 10/16 |
| Nausea and vomitingGeneral disorders | 7/16 | 9/16 |
| ProteinuriaGeneral disorders | 6/16 | 8/16 |
| NeutropeniaBlood and lymphatic system disorders | 4/16 | 7/16 |
| Watery eyesGeneral disorders | 0/16 | 6/16 |
| DehydrationGeneral disorders | 3/16 | 4/16 |
| Age, Categorical(Participants) | rhuMAB-VEGF | rhuMAB-VEGF and Docetaxel | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 11 | 17 |
| >=65 years | 10 | 5 | 15 |
| Sex: Female, Male(Participants) | rhuMAB-VEGF | rhuMAB-VEGF and Docetaxel | Total |
|---|---|---|---|
| Female | 10 | 8 | 18 |
| Male | 6 | 8 | 14 |
| Region of Enrollment(participants) | rhuMAB-VEGF | rhuMAB-VEGF and Docetaxel | Total |
|---|---|---|---|
| United States | 16 | 16 | 32 |
This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Fox Chase Cancer Center