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Rectal Cancer PatientsPhase 2NCT01426074

DCE-MRI PET Bevacizumab Study in Rectal Cancer

A Phase 2 study testing Bevacizumab 5 mg/kg in people with Rectal Cancer Patients, run by Abramson Cancer Center at Penn Medicine.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will determine the following: the response rate (including pathological CR rate), TTP, and complications of treatment in patients with rectal cancer treated with FOLFOX bevacizumab, the alteration of tumor blood flow (assessed by DCE-MRI as percentage change in Ktrans) after 1 cycle of bevacizumab therapy… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer Patients
What is being tested?
Bevacizumab 5 mg/kg
Type of treatment
Injection or infusion
How many people
0 participants
Where
No sites listed yet
Study dates
Aug 2011to 11 Jun 2014
Phase
Phase 2
Are there results?
None posted in the registry

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

Who may be able to join

  • Patients must have histologically documented advanced or metastatic adenocarcinoma of the rectum, T3 or T4, N any, M0 or M1. Patients must have available and identified tissue for immunohistochemical analysis and agree to submit it for the correlative endpoints. When available, formalin-fixed,paraffin-embedded tissue from previous biopsy or surgical resection will suffice.
  • Patients must measurable disease as defined by the RECIST criteria as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20mm with conventional techniques on either CT, MRI, or EUS. marker (CEA) elevation alone is in sufficient for entry.
  • Patients may have had prior adjuvant treatment of rectal cancer. The prior treatment regimen must not have included bevacizumab but may have included oxaliplatin and the last dose of chemotherapy must have been > 6 months prior to study entry. Patients with prior radiotherapy are acceptable. It must be at least 2 weeks since administration of radiation therapy and all signs of toxicity must have abated.
  • Patients with prior malignancies other than colorectal cancer are allowed, provided they have been treated with curative, intent, and have no evidence of recurrence of that malignancy.
  • Patients must be age 18 years or older.
  • Patients must have an ECOG performance status of 0-1.
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  • The following required required Initial Laboratory Values should be obtained within 4 weeks of the start of treatment:
  • Granulocytes ≥ 1,500/ml Platelet Count ≥ 100,000/ml Creatinine ≤ 1.5 x upper limit of normal Bilirubin ≤ 1.5 x upper limit of normal AST ≤ 5 x upper limit of normal Urine: Urine protein: creatinine ration ≤ 1.0 at screening
  • Patients must not be pregnant or lactating as chemotherapy is though to present substantial risk to the fetus/infant
  • Patients must have a life expectancy of greater than three months.
  • Patients must have the ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Patients may not be receiving any other investigational agents.
  • Patients with the following contraindication to MRI are excluded: Hypersensitivity to gadolinium Contraindicated metallic device, including pacemaker, non-MRI compatible aneurysm clip, other non-MRI compatible mechanical and/or electrical device, or metallic fragments.
  • Patients with severe claustrophobia
  • Patients with a history of allergic reactions attributed to Flagyl (metronidazole) which has a chemical structure similar to EF5 are excluded.
  • Patients with T1 or T2 N0M0 disease are not eligible.
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days to Day 0, anticipation of need for major surgical procedure during the course of the study. Minor surgical procedures such as port placement, fine needle aspirations or core biopsies within 3 days prior to Day 0.
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  • Patients with serious nonhealing wounds, ulcers, or bone fractures.
  • Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0.
  • Patients with a history of myocardial infarction, unstable angina, or cerebrovascular accident < 6 months prior to registration.
  • Patients with clinically significant peripheral vascular disease.
  • Patients with New York Heart Association Class II or greater congestive heart failure (Class II is defined as symptoms of fatigue, dyspnea or other symptoms with ordinary physical activity) See Appendix E.
  • Patients using oral or parenteral anticoagulation are not excluded provided they are on a stable dose of anticoagulant.
  • patients with pre-existing hypertension should be on a stable antihypertensive regimen and have a blood pressure ≤ 150/100 mmHg at the time of enrollment.
  • Patients must not have known brain metastases because the study drug has not been adequately tested in this setting.

About this study

Official title: A Phase II/Pharmacodynamic Study of Preoperative or Definitive FOLFOX Plus Bevacizumab, With the Additional Pharmacodynamic Goal of Assessing Tumor Blood Flow as Measured by Dynamic Contrast-enhanced MRI, and the Induction of Hypoxia and Apoptosis as Measured by PET in Patients With Rectal Cancer

This study will determine the following: the response rate (including pathological CR rate), TTP, and complications of treatment in patients with rectal cancer treated with FOLFOX bevacizumab, the alteration of tumor blood flow (assessed by DCE-MRI as percentage change in Ktrans) after 1 cycle of bevacizumab therapy compared to baseline value in patients treated with FOLFOX alone and those treated with bevacizumab at 5 mg/kg., the degree of hypoxis (measured by tumor uptake of the 2-nitroimidazole EF5) induced by bevacizumab treatment and its relationship to changes in tumor blood flow, and the degree of apoptosis (measured by tumor uptake of di-annexin V) induced by bevacizumab treatment and its relationship to changes in tumor blood flow.

Read the detailed description

The primary objectives of this study will determine the following: the response rate (including pathological CR rate), TTP, and complications of treatment in patients with rectal cancer treated with FOLFOX bevacizumab, the alteration of tumor blood flow (assessed by DCE-MRI as percentage change in Ktrans) after 1 cycle of bevacizumab therapy compared to baseline value in patients treated with FOLFOX alone and those treated with bevacizumab at 5 mg/kg., the degree of hypoxis (measured by tumor uptake of the 2-nitroimidazole EF5) induced by bevacizumab treatment and its relationship to changes in tumor blood flow, and the degree of apoptosis (measured by tumor uptake of di-annexin V) induced by bevacizumab treatment and its relationship to changes in tumor blood flow. The secondary objectives of this study is to determine in an exploratory fashion the relationship between tumor blood flow, hypoxia induction, and apoptosis induction , and time to progression in patients continuing on to receive Bevacizumab 5 mg/kg, to analyze archival tumor from the patients treated in this trial for mutations in the MKK7 and SEK1 genes, and by semi-quantitative IHC for these and other relevant proteins, to determine the relationship between vascular proliferation as measured by DCE-MRI and markers of endothelial cell proliferation, and to obtain pilot data on whether assays that measure vascular endothelial cell mitogenic stimulation and mitogenic activity may predict response to therapy, time to progression and overall survival in patients receiving bevacizumab 5 mg/kg.

Being tested
Bevacizumab 5 mg/kg

What participants receive

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

  • Bevacizumab 5 mg/kgDrug

    Intravenously every two weeks

What is being measured

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

  1. Pathologic Complete Response (pCR)

Timeline

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

  1. First posted31 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completion11 Jun 2014
  4. Study completion11 Jun 2014

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
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01426074
Sponsor's protocol ID
UPCC 05209
Status last verified
Aug 2018
First submitted
29 Aug 2011
Last updated
21 Aug 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab 5 mg/kg in people with Rectal Cancer Patients, run by Abramson Cancer Center at Penn Medicine.

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

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Pathologic Complete Response (pCR). 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 NCT01426074.

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 21 Aug 2018.

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