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Colorectal CancerPhase 2NCT00513266

Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer With Liver Metastases or Lung Metastases That Are Potentially Removable by Surgery

A Phase 2 study testing bevacizumab, cetuximab and fluorouracil in people with Colorectal Cancer and Metastatic Cancer, run by Centre Hospitalier Universitaire Vaudois at 4 sites in Switzerland.

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 The sponsor has not verified this record for over two years, so it may be out of date.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: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 to 70 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
35 participants
Where
4 sitesSwitzerland
Study dates
Jun 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed metastatic colorectal adenocarcinoma
  • Bidimensionally measurable metastatic disease limited to the liver and considered curatively resectable after response to systemic therapy as assessed by a surgical board
  • Additional metastatic disease to the lungs consisting of no more than 3 potentially resectable lesions allowed
  • Must have at least one lesion of 30 mm or less
  • Performance status ≤ 1
  • Life expectancy > 12 weeks
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  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Creatinine 1.25 x upper limit of normal (ULN)
  • Bilirubin 1.25 x ULN (1.5 x ULN if liver metastasis)
  • AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastasis)
  • Woman and men of childbearing age must use adequate contraception

Who cannot join

  • History or evidence upon physical examination of CNS disease unless adequately treated (e.g., uncontrolled seizure with standard medical therapy or history of stroke)
  • PATIENT CHARACTERISTICS:
  • Pregnancy (positive serum pregnancy test) or lactation
  • Chronic diarrhea ≥ grade 2
  • Other serious illness or medical condition including any of the following:
  • Unstable cardiac disease requiring treatment
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  • Congestive heart failure or angina pectoris even if medically controlled
  • Significant arrhythmias
  • History of significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent
  • Active uncontrolled infection
  • Severe hypercalcemia
  • Other serious underlying medical condition that could impair the ability of the patient to participate in the study
  • Neuropathy > grade 1 of any etiology
  • Known DPD deficiency
  • Known severe polyneuropathy
  • Known allergy to Chinese hamster ovary cell proteins, other recombinant human or humanized antibodies, any excipients of bevacizumab formulation, or any other study drugs
  • Chronic inflammatory bowel disease
  • Acute or subacute intestinal occlusion
  • History of previous arterial thromboembolism
  • Uncontrolled hypertension
  • Evidence of bleeding diathesis or coagulopathy
  • Serious nonhealing wound, ulcer, or bone fracture
  • History of tumor other than basocellular carcinoma of the skin
  • Peripheral neuropathy > grade 1 of any origin (e.g., alcohol)
  • Significant traumatic injury within 28 days prior to study treatment
  • PRIOR CONCURRENT THERAPY:
  • No prior chemotherapy for metastatic disease
  • Prior adjuvant chemotherapy permitted if interval since last treatment administration and recurrence is > 6 months
  • Major surgical procedure or open biopsy within 28 days prior to study treatment or anticipation of the need for major surgical procedure during the course of the study
  • Treatment in a clinical trial within 30 days prior to study entry
  • Concurrent treatment with other experimental drugs or other anticancer therapy
  • Current or recent use (within 10 days prior to study treatment) of full-dose oral or parenteral anticoagulants for therapeutic purposes
  • Chronic daily treatment with aspirin (> 325 mg/day)

Trial locations and contacts

4 sites in 1 country.

Switzerland4 sites

  • Kantonspital Aarau

    Chur, CH-7000

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Hopital Regional de Sion-Herens-Conthey

    Sion, CH -1951

Other trials in Switzerland

About this study

Official title: Oxaliplatin-CPT-11-5-FU-Leucovarin + Bevacizumab and Cetuximab (OCFL-BC) as a Combination Regimen for Systemic Treatment of Advanced Colorectal Carcinoma With Potentially Resectable Liver and/or Lung Metastases. A Phase II Study

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and cetuximab, 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. Giving combination chemotherapy together with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with monoclonal antibody therapy works in treating patients with advanced colorectal cancer with liver metastases or lung metastases that are potentially removable by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the pathological complete response (CR) rate in resected patients assessed on lesions of less than or equal to 30 mm in size.

Secondary

  • To determine the clinical CR rate in all patients.
  • To determine toxicity and tolerability of this regimen (pre- and postoperative toxicity).
  • To evaluate perioperative safety in these patients.
  • To determine disease-free survival (time to progression in unresected patients) and overall survival of the whole study population.
  • To determine resectability in these patients.
  • To evaluate markers that predict the occurrence of a pathological CR or a non-response in pathological material (resected liver metastasis) and biological material collected from these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, oxaliplatin IV over 2 hours on days 1 and 15, irinotecan hydrochloride IV over 30 minutes on days 8 and 22, fluorouracil IV over 24 hours on days 1, 8, 15, and 22, leucovorin calcium IV on days 1, 8, 15, and 22, and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 5 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients who are able to undergo liver resection receive bevacizumab on day 1 only of course 3 and undergo liver resection 3 weeks after chemotherapy. Beginning 4 weeks after liver resection, patients receive 2 additional courses of chemotherapy as adjuvant therapy.

Patients undergo tumor tissue and blood sample collection periodically for biological studies. Samples are analyzed for markers that predict the occurrence of a complete pathological response (pCR) or a non-response.

After completion of study treatment, patients are followed every 3 months for the first 2 years and then every 6 months thereafter.

Keywords
recurrent rectal cancer, stage IV rectal cancer, recurrent colon cancer, stage IV colon cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, liver metastases, lung metastases
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis, Rectal Neoplasms, Colonic 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. Pathological complete response rate of lesions of less than or equal to 30 mm in size assessed by pathologic examination in resected specimens

Secondary outcomes (2)

  1. Response as assessed by NCIC criteria

  2. Toxicity as assessed by NCIC criteria

Timeline

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

  1. First posted8 Aug 2007 (estimated)
  2. Study startJun 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
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00513266
Sponsor's protocol ID
CDR0000559146
Other IDs
CHUV-CH-OCFL-BC, EU-20741
Status last verified
Jun 2009
First submitted
6 Aug 2007
Last updated
7 Aug 2009
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 Centre Hospitalier Universitaire Vaudois at 4 sites in Switzerland.

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 12 inclusion and 33 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: status not confirmed, as of the sponsor's last update on 7 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Switzerland. 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?

Pathological complete response rate of lesions of less than or equal to 30 mm in size assessed by pathologic examination in resected specimens. 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 NCT00513266.

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 7 Aug 2009.

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