First-line Bevacizumab and Chemotherapy in Metastatic Cancer of the Colon or Rectum. An Expanded Access Program. - First BEAT

Phase 1

• Conditions: Metastatic cancer of the colon or rectum.

• Registration Number: EUCTR2004-000315-26-SK
• Lead Sponsor: F.Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-06
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Patients with histologically confirmed diagnosis of metastatic CRC, untreated yet with chemotherapy for metastatic disease (prior adjuvant chemotherapy for colorectal cancer allowed), who are scheduled to start first line fluoropyrimidine-based chemotherapeutic treatment.
2. Age = 18.
3. Measurable or non-measurable disease.
4. Performance status ECOG performance status 0 or 1.
5. Life expectancy greater than 3 months.
6. Neutrophils = 1’500/µl, Platelets = 100’000/µl, AST/ALT = 2.5 × ULN (< 5 × ULN if liver metastases), Alkaline phosphatase = 2.5 × ULN, Serum bilirubin = 1.5 × ULN, Serum Creatinine = 1.5 × ULN.
Urine dipstick of proteinuria <2+. Patients discovered to have equal to or greater than 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate equal to or less than 1 g of protein/24 hr.
7. Women of childbearing potential must have a negative serum pregnancy test done 1 week prior to the administration of the study drug. She and her partner should prevent pregnancy (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) up to at least 6 months after last treatment completion or the last drug dose, whatever happens first.
8. Signed written informed consent according to ICH/GCP and the local regulations (approved by the Institutional Review Board [IRB]/Independent Ethics Committee [IEC]) will be obtained prior to any study specific screening procedures.
9. Patient must be able to comply with the protocol
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. Treatment with first-line chemotherapy for metastatic CRC.
2. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery), or anticipation of need for major surgical procedure during the course of the study.
3. Planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed).
4. Clinical or radiological evidence of CNS metastases.
5. Past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated:
- Basal and squamous cell carcinoma of the skin
- In-situ carcinoma of the cervix
6. Serious non-healing wound or ulcer.
7. Evidence of bleeding diathesis or coagulopathy.
8. Uncontrolled hypertension.
9. Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (= 6 months), myocardial infarction (= 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.
10. Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes i.e. except for anticoagulation for maintenance of patency of permanent indwelling IV catheters.
11. Treatment with any investigational drug (including IMMP, EGFR inhibitors, COX-2 inhibitors) or participation in another investigational study within 30 days prior to enrolment.
12. 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 drug or patient at high risk from treatment complications
13. Ongoing treatment with aspirin (> 325 mg/day) or other medications known to predispose to gastrointestinal ulceration
14. Pregnancy (positive serum pregnancy test) and lactation
15. Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified