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TerminatedNCT00066677Updated Mar 5, 2021Results posted

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

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

Why this study was terminated
Stopped accordining to early stopping rule for futility
Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • adenocarcinoma of the pancreas
  • recurrent pancreatic cancer
  • stage IV pancreatic cancer
03

In context

Pancreatic Neoplasms

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    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.

    Drug: rhuMAB-VEGF

  • Experimental
    rhuMAB-VEGF and 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.

    Drug: rhuMAB-VEGF · Drug: docetaxel

Interventions

  • DrugrhuMAB-VEGF
  • Drugdocetaxel
06

What researchers measure

Primary outcomes

  1. Progression-free Survival

    Time frame: 4 months

Secondary outcomes

  1. Objective Response Rate

    Time frame: 56 days

  2. Overall Survival

    Time frame: From date of registration until the date of death, assessed up to 5 years

  3. Number of Participants With Thromboembolic Events

    Time frame: 93 days

07

Results

Posted Mar 5, 2021
Limitations and caveats
The study was stopped according to the early stopping rule for futility.

Participant flow

Study was conducted at Fox Chase Cancer Center between October 2004 and December 20006.

Participant flow — Overall Study
MilestonerhuMAB-VEGFrhuMAB-VEGF and Docetaxel
Started1616
Completed1616
Not completed00

Outcome measures

PrimaryProgression-free Survival
Time frame:
4 months
Reported as:
Median · days
Progression-free Survival
daysrhuMAB-VEGFrhuMAB-VEGF and Docetaxel
Progression-free Survival43 (28 to 120)48 (28 to 120)
SecondaryObjective Response Rate
Time frame:
56 days
Reported as:
Number · participants
Objective Response Rate
participantsrhuMAB-VEGFrhuMAB-VEGF and Docetaxel
Objective Response Rate00
SecondaryOverall Survival
Time frame:
From date of registration until the date of death, assessed up to 5 years
Reported as:
Median · days
Overall Survival
daysrhuMAB-VEGFrhuMAB-VEGF and Docetaxel
Overall Survival165 (28 to 480)125 (28 to 480)
SecondaryNumber of Participants With Thromboembolic Events
Time frame:
93 days
Reported as:
Number · participants
Number of Participants With Thromboembolic Events
participantsrhuMAB-VEGFrhuMAB-VEGF and Docetaxel
Number of Participants With Thromboembolic Events32

Adverse events

Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
rhuMAB-VEGF16/16 (100%)13/16 (81.3%)0/16 (0%)
rhuMAB-VEGF and Docetaxel16/16 (100%)15/16 (93.8%)0/16 (0%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
EventrhuMAB-VEGFrhuMAB-VEGF and Docetaxel
FatigueGeneral disorders13/1615/16
AnemiaBlood and lymphatic system disorders12/1615/16
AnorexiaGeneral disorders10/1611/16
LeukopeniaBlood and lymphatic system disorders5/1611/16
HypoalbuminemiaGeneral disorders9/1610/16
Nausea and vomitingGeneral disorders7/169/16
ProteinuriaGeneral disorders6/168/16
NeutropeniaBlood and lymphatic system disorders4/167/16
Watery eyesGeneral disorders0/166/16
DehydrationGeneral disorders3/164/16

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)rhuMAB-VEGFrhuMAB-VEGF and DocetaxelTotal
<=18 years000
Between 18 and 65 years61117
>=65 years10515
Sex: Female, Male
Sex: Female, Male(Participants)rhuMAB-VEGFrhuMAB-VEGF and DocetaxelTotal
Female10818
Male6814
Region of Enrollment
Region of Enrollment(participants)rhuMAB-VEGFrhuMAB-VEGF and DocetaxelTotal
United States161632
08

Study locations

1 site
  • Fox Chase Cancer Center - Philadelphia
    Philadelphia, Pennsylvania 19111-2497, United States
09

References and documents

Publications

  • 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. PubMed 20458210 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00066677
Lead sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Aug 7, 2003
Start date
Oct 2003
Primary completion
Nov 2008
Completion
Apr 2009
Results posted
Mar 5, 2021
Last update
Mar 5, 2021

Study contacts

Steven J. Cohen, MD
study chair · Fox Chase Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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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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