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Colorectal CancerPhase 2NCT00438737

Cetuximab, Leucovorin, Oxaliplatin, and Fluorouracil With or Without Bevacizumab in Treating Patients With Resectable Liver Metastases From Colorectal Cancer

A Phase 2 study testing bevacizumab, cetuximab and fluorouracil in people with Colorectal Cancer and Metastatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Colorectal Cancer, Metastatic Cancer
What is being tested?
bevacizumab, cetuximab and fluorouracil
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteFrance
Study dates
Jan 2007to not given
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Diagnosis of metastatic colorectal cancer, meeting all of the following criteria:
  • Metachronous or synchronous liver metastases
  • Metastases potentially completely resectable
  • No requirement for resection combined with cryotherapy or radiofrequency ablation
  • Must have undergone complete resection (R0) of the primary tumor within the past 4 weeks
  • Measurable liver metastases
  • No evidence of extrahepatic disease
  • 1 or 2 resectable lung metastases allowed

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Absolute neutrophil count > 1,500/mm³
  • Platelet count > 100,000/mm³
  • Hemoglobin > 9 g/dL
  • WBC > 3,000/mm³
  • Creatinine < 1.5 times upper limit of normal (ULN)
  • Bilirubin < 1.5 times ULN
  • AST and ALT < 5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant proteinuria (i.e., protein > 500 mg/24-hour urine collection)
  • No known allergy to any of the study drugs (including excipients) or any related compound, including hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
  • No bleeding diathesis or coagulopathy
  • No peripheral neuropathy > grade 1
  • No serious nonhealing wound, ulcer, or bone fracture
  • No clinically significant cardiovascular disease, including any of the following:
  • Uncontrolled hypertension
  • New York Heart Association class II-IV congestive heart failure
  • Unstable angina pectoris within the past 12 months
  • Peripheral vascular disease ≥ grade 2
  • Serious cardiac arrhythmia requiring medication
  • Myocardial infarction within the past 12 months
  • Cerebrovascular accident or transient ischemic attack within the past 12 months
  • No symptomatic diverticulitis or known gastroduodenal ulceration
  • No significant traumatic injury within the past 4 weeks
  • No known alcohol or drug abuse
  • No psychological, familial, social, or geographical condition that would preclude study compliance
  • No other significant disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy for metastatic disease
  • At least 1 month since prior major surgical procedure or open biopsy
  • More than 30 days since prior participation in another clinical study
  • Prior adjuvant chemotherapy for primary cancer allowed provided the following criteria are met:
  • At least 12 months since prior oxaliplatin-containing adjuvant therapy
  • No persistent neuropathy
  • No prior therapy targeting the epidermal growth factor receptor or vascular endothelial growth factor (VEGF)/VEGF receptor
  • No concurrent regular use of acetylsalicylic acid (> 325 mg/day) or other nonsteroidal anti-inflammatory drugs
  • No concurrent full-dose anticoagulation
  • No concurrent prophylactic hematopoietic growth factors
  • No concurrent allopurinol

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hopital Ambroise Pare

    Boulogne, F-92104

Other trials in France

About this study

Official title: Randomized Phase II Trial Evaluating the Feasibility and Tolerance of the Combination of FOLFOX With Cetuximab and the Combination of FOLFOX With Cetuximab and Bevacizumab as Perioperative Treatment in Patients With Resectable Liver Metastases From Colorectal Cancer

RATIONALE: Monoclonal antibodies, such as cetuximab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.Drugs used in chemotherapy, such as leucovorin, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with combination chemotherapy and bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This randomized phase II trial is studying the side effects and how well giving cetuximab together with leucovorin, oxaliplatin, and fluorouracil works with or without bevacizumab in treating patients with resectable liver metastases from colorectal cancer.

Read the detailed description

OBJECTIVES:

  • Compare the safety and activity of neoadjuvant and adjuvant cetuximab, leucovorin calcium, oxaliplatin, and fluorouracil with vs without bevacizumab in patients with resectable liver metastases secondary to colorectal cancer.

OUTLINE: This is an open-label, randomized, multicenter study. Patient are stratified according to participating center and planned liver resection (major [≥ 3 segments] vs minor [< 3 segments]). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive leucovorin calcium IV over 2 hours and oxaliplatin IV over 2 hours on day 1 and fluorouracil IV over 46 hours (FOLFOX) beginning on day 1. Patients also receive cetuximab IV over 1-2 hours on days 1 and 8. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Between 3-5 weeks after completion of FOLFOX and cetuximab, patients undergo liver resection. Beginning between 4-8 weeks after surgery, patients receive another 6 courses of FOLFOX and cetuximab as in neoadjuvant therapy.

  • Arm II: Patients receive FOLFOX and cetuximab as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days for 6 courses* in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients do not receive bevacizumab during course 6

Between 3-5 weeks after completion of FOLFOX, cetuximab, and bevacizumab, patients undergo liver resection. Beginning between 4-8 weeks after surgery, patients receive another 6 courses of FOLFOX, cetuximab, and bevacizumab as in neoadjuvant therapy.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for at least 3 years.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Keywords
liver metastases, stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms, Rectal Neoplasms

What participants receive

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

What is being measured

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

  1. Response rate (preoperative response rate)

  2. Safety (rate of perioperative safety findings)

Secondary outcomes (3)
  1. Progression-free survival

  2. Pathological resection rate

  3. Overall survival

Timeline

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

  1. First posted22 Feb 2007 (estimated)
  2. Study startJan 2007

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
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00438737
Sponsor's protocol ID
CDR0000530116
Other IDs
EORTC-40051, EUDRACT-2005-002825-29, EU-20776
Status last verified
Sep 2007
First submitted
20 Feb 2007
Last updated
2 Sep 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab, cetuximab and fluorouracil in people with Colorectal Cancer and Metastatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in France.

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: status not confirmed, as of the sponsor's last update on 2 Sep 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 France. 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?

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?

Response rate (preoperative response rate). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Sep 2011.

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