AzTrials
AzTrials

Pancreatic CancerPhase 2NCT00066677

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

A Phase 2 study testing rhuMAB-VEGF and docetaxel in people with Pancreatic Cancer, run by Fox Chase Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
rhuMAB-VEGF and docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
Oct 2003to Apr 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

Other trials in United States

About this study

Official title: Phase II and Coagulation Study of rhuMAb-VEGF With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma

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.

Being tested
rhuMAB-VEGF, docetaxel
Keywords
adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage IV pancreatic cancer
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00066677
Study groupRoleWhat they receive
rhuMAB-VEGFExperimentalbevacizumab 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks until disease progression, unacceptable toxicity or patient preference.
Receives: Drug: rhuMAB-VEGF
rhuMAB-VEGF and DocetaxelExperimentalrhuMAB-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.
Receives: Drug: rhuMAB-VEGF; Drug: docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival

    Measured: 4 months

Secondary outcomes (3)
  1. Objective Response Rate

    Measured: 56 days

  2. Overall Survival

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

  3. Number of Participants With Thromboembolic Events

    Measured: 93 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2003 (estimated)
  2. Study startOct 2003
  3. Primary completionNov 2008
  4. Study completionApr 2009

Why it stopped: Stopped accordining to early stopping rule for futility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00066677
Sponsor's protocol ID
CDR0000316454
Other IDs
P30CA006927, FCCC-03003
Status last verified
Feb 2021
First submitted
6 Aug 2003
Last updated
5 Mar 2021
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rhuMAB-VEGF and docetaxel in people with Pancreatic Cancer, run by Fox Chase Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00066677, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in