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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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7 September 2021 |
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Main ID: |
EUCTR2004-004021-98-ES |
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Date of registration:
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07/12/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A single arm Phase IV study to assess efficacy and safety of bevacizumab in combination with irinotecan and infusional 5-fluorouracil/folinic acid regimens as first line treatment for patients with metastatic colorectal cancer. - N/A
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Scientific title:
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A single arm Phase IV study to assess efficacy and safety of bevacizumab in combination with irinotecan and infusional 5-fluorouracil/folinic acid regimens as first line treatment for patients with metastatic colorectal cancer. - N/A |
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Date of first enrolment:
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28/02/2005 |
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Target sample size:
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200 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004021-98 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Italy
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Written informed consent (approved by the Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures.
2. Age =18 years
3. Patient must be able to comply with the protocol.
4. Histologically or cytologically confirmed carcinoma of the colon and/or rectum with evidence of metastases (new confirmation of metastatic disease is required in case the time interval from last histological/cytological diagnosis to enrolment exceeds 3 years).
5. Diagnosis of metastatic disease for which treatment will have to be started not more than 3 months prior to enrolment.
6. Life Expectancy of at least 3 months.
7. At least one measurable metastatic lesion (as per RECIST criteria)
8. Prior adjuvant or neo-adjuvant chemotherapy/radiotherapy allowed if completed more than 6 months before inclusion.
9. ECOG performance score of 0 or 1
10. Adequate haematological function: ANC =1.5 x 10(9)/L; platelets = 100 x 10(9)/L, Hb =9 g/dL
11. INR = 1.5; aPTT = 1.5 x ULN within 7 days prior to starting study treatment
12. Adequate liver function: Serum bilirubin = 1.5 x ULN; alkaline phosphatase and transaminases = 2.5 x ULN (in case of liver metastases < 5 x ULN)
13. Serum Creatinine = 1.5 x ULN
14. Urine dipstick for proteinuria < 2+. If urine dipstick is = 2+, 24- hour urine must demonstrate = 1 g of protein in 24 hours.
15. Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women < 2 years after the onset of menopause. This test has to be reconfirmed by a urine test, should the 7 days window be exceeded.
Fertile women and men of childbearing potential (<2 years after last menstruation in women) must use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Patients who received adjuvant irinotecan or antiVEGF treatment
2. Prior chemotherapeutic treatment for metastatic CRC
3. Clinical evidence of brain metastases
4. Past or current history (within the last 2 years prior to treatment start) of other malignancies except metastatic colorectal cancer (Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
5. Clinically significant cardiovascular disease, for example CVA (= 6 months before treatment start), myocardial infarction (= 6 months before treatment start), unstable angina, NYHA = grade 2 CHF, arrhythmia requiring medication, or uncontrolled hypertension.
6. Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study.
7. Known hypersensitivity to any of the study drugs.
8. Current or recent (within 10 days of first dose of study treatment) chronical use of aspirin (> 325 mg/day) or other NSAID with anti-platelet activity.
9. Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes.
10. History of thromboembolic or haemorrhagic events within 6 months prior to treatment.
11. Evidence of bleeding diathesis or coagulopathy.
12. Serious, non healing wound, ulcer, or bone fracture.
13. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment, or anticipation of the need for major surgery during the course of the study. CVAD for chemotherapy administration inserted within 2 days prior to study treatment start.
14. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
15. Pregnancy or lactation
16. Fertile women (<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Metastatic colorectal cancer
MedDRA version: 7
Level: PT
Classification code 10009954
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Intervention(s)
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Trade Name: AVASTIN
Product Name: Bevacizumab
Product Code: RO4876646
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Bevacizumab
CAS Number: 216974-75-3
Current Sponsor code: RO4876646
Other descriptive name: rhuMAb, VEGF, anti-VEGF
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25mg/ml-
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Primary Outcome(s)
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Main Objective: To determine the efficacy of bevacizumab in combination with irinotecan and infusional 5-fluorouracil plus folinic acid based regimens as compared with historical controls, based on progression free survival.
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Primary end point(s): Progression free survival (PFS), defined as the time period form the start of study medication to disease progression or death from any cause, whichever occurs first.
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Secondary Objective: - To evaluate the safety profile of bevacizumab in combination with irinotecan and infusional 5-fluorouracil plus folinic acid based regimens.
- To determine the overall response rate, time to response, duration of response, and overall survival of bevacizumab in combination with irinotecan and infusional 5-fluorouracil plus folinic acid based regimens as compared with historical controls.
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Secondary ID(s)
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MO18458
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2004-004021-98-IT
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 08/02/2005
Contact:
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