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Colorectal CarcinomaPhase 2APRIORINCT01126866

Curative Resectability of Not Optimally Resectable Liver and/or Lung Metastases From Colorectal Carcinoma (CRC) Under Intensified Chemotherapy

A Phase 2 study testing intensified chemotherapy (FOLFOXIRI/Bevacizumab) in people with Colorectal Carcinoma, run by National Center for Tumor Diseases, Heidelberg at 1 site in Germany.

Terminated

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

Official record
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Trial summary

The purpose of this clinical trial is to primarily assess the efficacy of an intensified chemotherapy consisting of a combination of FOLFOXIRI + bevacizumab. The main focus will be laid on the rate of patients who achieve secondary complete (R0)-resectable metastases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Carcinoma
What is being tested?
intensified chemotherapy (FOLFOXIRI/Bevacizumab)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteGermany
Study dates
Jun 2009to Jun 2011
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

  • Age ≥18 years
  • Indication:
  • Histologically confirmed advanced colorectal carcinoma of UICC Stages IV with liver and/or lung only metastases,which are not optimally resectable
  • Measurable disease according to RECIST criteria.
  • In case of liver metastases: 70% liver replacement and/or > 6 segments tumor involved, and/or involvement of all three hepatic veins, and/or involvement of the right and left portal pedicle, and/ or involvement of the vena cava.
  • In case of lung metastases: No tumor with direct infiltration of myocardium, esophagus, spine or intrapericardial large vessels. Preoperative data indicate a significant loss of pulmonary function after pulmonary metastasectomy with severe impairment of quality of life.
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  • ECOG performance status of < 2.
  • Life expectancy of > 3 months
  • Laboratory parameters:
  • Proteinuria at baseline:
  • Patients with proteinuria <2+ on dipstick urinalysis.
  • Patients with 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-h urine collection and must have proteinuria <= 1 g of protein/24 h.
  • The required laboratory values at baseline are as follows:
  • Hematology:
  • Absolute neutrophil count (ANC) > 1.5 x 109/L
  • Platelet count > 100 x 109/L
  • Hemoglobin > 9 g/dL (may be transfused to maintain or exceed this level)
  • International Normalized Ratio (INR) < 1.5; aPTT <1.5 x ULN
  • Biochemistry:
  • Total bilirubin < 1.5 x upper limit of normal (ULN)
  • AST, ALT < 2.5 x ULN in patients without liver metastases; < 5 x ULN in patients with liver metastases
  • Serum creatinine <2.0 mg/dL or 177 ƒÝmol/L
  • Willingness to give written informed consent, written consent for data protection and willingness to participate and to comply with the study.

Who cannot join

  • Past or current history of malignancies other than colorectal carcinoma. Patients with curatively treated basal and squamous cell carcinoma of the skin and/or in-situ carcinoma of the cervix are eligible.
  • Previous chemotherapy (except adjuvant chemotherapy).
  • Extrahepatic and/or extrapulmonary meta-stases except of the initially removed lymph node metastases.
  • History or evidence upon physical examination of CNS disease unless adequately treated (e.g., seizure not controlled with standard medical therapy or history of stroke).
  • Major surgical procedures, open biopsy, or significant traumatic injury within 28 days prior to study treatment start (wound healing has to be completed), or anticipation of the need for major surgical procedure during the course of the study.
  • Evidence of bleeding diathesis or coagulopathy
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  • Serious, non-healing wound, ulcer, or bone fracture
  • Treatment with investigational agents or participation in clinical trials within 30 days before study entry.
  • Clinically significant (i.e. active) cardiovascular disease, e.g., uncontrolled hyper-tension, cerebrovascular accidents (. 6 months prior to treatment start), myocardial infarction (. 6 months prior to treatment start), unstable angina, New York Heart Association (NYHA) grade . II, congestive heart failure, serious cardiac arrhythmia requiring medication.
  • Current or recent serious polyneuropathy (grade . 1 according to NCI CTCAE v3.0 criteria; exception: absence of tendon reflexes)
  • Hematopoietic diseases.
  • Known intra-abdominal inflammatory pro-cess or serious gastrointestinal ulceration.
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Thromboembolic events or severe hemorrhage ("T 6 months before treatment start).
  • Known hypersensitivity to oxaliplatin, the background medication (bevacizumab, FA or 5-FU) or to their compounds, incl. Chinese hamster ovary (CHO) cell proteins or other recombinant human or humanized antibodies.
  • Known Gilbert-Syndrome
  • Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational regimen or patient at high risk from treatment complications
  • As the following medication(s) can have interactive effects and may interfere with the patient's ability to meet the study requirements, they cannot be administered during the clinical study:
  • sorivudine or analog compounds.
  • Current or recent (within 10 days of first dose of study treatment) treatment with full-dose oral or parenteral anticoagulants or thrombolytic agents (e.g., marcumar therapy) for therapeutic purposes.
  • Current or recent (within 10 days of first dose of study treatment) chronic use of aspirin (> 325 mg/day) or clopidogrel (> 75 mg/day).
  • Women, lactating, pregnant or of child-bearing potential and fertile men not using a highly effective contraceptive method1.
  • [Women of childbearing potential must have a negative pregnancy test (serum b-HCG) within 7 days before the first dose of study drug].
  • Patients who are confined by order of either judicial or administrative authorities (according to ¡± 40 Abs. 1 S. 3 AMG).
  • Patients who are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to ¡± 40 Abs. 4 and ¡± 41 Abs. 2 and Abs. 3 AMG).
  • Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.
  • Patients who possibly are dependent on the sponsor or investigator.
  • Patients who have participated in this study before.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • NCT

    Heidelberg, 691220

Other trials in Germany

About this study

Official title: Phase II Study on Curative Resectability of Not Optimally Resectable Liver and/or Lung Metastases From Colorectal Carcinoma (CRC) Under Intensified Chemotherapy (FOLFOXIRI/ Bevacizumab)

The purpose of this clinical trial is to primarily assess the efficacy of an intensified chemotherapy consisting of a combination of FOLFOXIRI + bevacizumab. The main focus will be laid on the rate of patients who achieve secondary complete (R0)-resectable metastases.

The FOLFIRI + bevacizumab as well as the FOLFOXIRI regimens have been shown previously to be both effective in the treatment of advanced CRC with having manageable toxicities. Therefore, an intensified chemotherapy combining these two standard regimens might be a promising therapeutic approach improving the treatment of metastatic disease and outcome of CRC.

Read more

Patients with advanced colorectal carcinoma of UICC stage IV, and liver and/or lung metasta¬ses only, which are not optimally resectable, will be enrolled in this single-arm phase II study.

A minimum of 4 cycles (=8 weeks) of chemo¬therapy prior to surgery is mandatory for all patients. However, patients may withdraw from the study at any time upon their own request. Treatment with preoperative chemothera¬py will continue until 2-4 weeks prior to surgery with the last application of bevacizumab (only FOLFOXIRI) 4 weeks before surgery, at longest 16 cycles (= 32 weeks) for candidates not eli¬gible for surgery. Treatment will be discontinued prematurely at disease progression or unacceptable toxicity.

As secondary endpoints the acute and perioperative toxi¬city of preoperative chemotherapy according to NCI CTCAE v 3.0 including all peri-and post-surgical complications as well as progression free survival and overall survival and quality of life will be assessed.

Being tested
intensified chemotherapy (FOLFOXIRI/Bevacizumab)
Keywords
advanced colorectal carcinoma, CRC, UICC Stages IV, liver and/or lung only metastases
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • intensified chemotherapy (FOLFOXIRI/Bevacizumab)Drug

    intensified chemotherapy (FOLFOXIRI/Bevacizumab)

Study groups in NCT01126866
Study groupRoleWhat they receive
preoperative chemotherapyExperimentalNot described
Receives: Drug: intensified chemotherapy (FOLFOXIRI/Bevacizumab)

What is being measured

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

  1. surgically complete resectability; S-CR

    To evaluate the proportion of patients who achieve surgically complete resectability (S-CR) of metastases after preoperative chemotherapy.

    Measured: 12 month after Surgery

Secondary outcomes (2)

  1. Evaluate the acute and perioperative toxicity of preoperative chemotherapy according to NCI CTCAE v3.0 and all peri-and post-surgical complications

    Descriptive analysis is performed to identify treatment side effects and their individual impact from the patients' perspective, as well as changes during treatment based on BELISPO questionnaire data.

    Measured: 12 month after surgery

  2. Survival rate (OS) and progression free survival (PFS)

    The PFS is calculated for all patients. It is defined as the time from admission to the study to objective tumor progression or death from any cause, whichever occurs first. OS is defined as the time from registration to death from any cause.

    Measured: 12 months after surgery or end of treatment.

Timeline

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

  1. First posted20 May 2010 (estimated)
  2. Study startJun 2009
  3. Primary completionMar 2011
  4. Study completionJun 2011

Why it stopped: recruiting inadequate

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01126866
Sponsor's protocol ID
NCT-2007-11-02-1003
Acronym
APRIORI
Status last verified
May 2011
First submitted
12 May 2010
Last updated
15 Jul 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing intensified chemotherapy (FOLFOXIRI/Bevacizumab) in people with Colorectal Carcinoma, run by National Center for Tumor Diseases, Heidelberg at 1 site in Germany.

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 23 inclusion and 28 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: stopped early, as of the sponsor's last update on 15 Jul 2011. 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 Germany. 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?

The study was stopped early (reason given: recruiting inadequate). Results are not available in the source record.

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?

surgically complete resectability; S-CR (time frame: 12 month after Surgery). 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 NCT01126866.

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 15 Jul 2011.

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