A blinded phase II study to evaluate the efficacy and safety of 2 different treatments arms (RO5520985 plus standard chemotherapy FOLFOX versus bevacizumab plus standard chemotherapy FOLFOX) in patients who have not been treated before for their metastatic disease of colorectal cancer.
- Conditions
- Patients with cancer of the colon or rectum where the tumor has already spread to other organs(s),MedDRA version: 17.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10055097Term: Rectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10055114Term: Colon cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-005108-32-ES
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 189
1.Histologically or cytologically confirmed mCRC not amenable to potentially curative resection with at least one measurable metastatic lesion, as defined by RECIST v1.1
a)Results of local RAS mutational analysis must be available for stratified randomization
b)Representative tumor specimens in FFPE blocks (preferred) or slides must be available for central extended RAS mutational analysis testing
2.Signed written informed consent, obtained prior to any screening procedure
3.Age> 18 years
4.ECOG (WHO) performance status of 0 or 1
5.Adequate hematologic, liver, renal, coagulation and cardiovascular function
6.Recovery from all reversible adverse events of previous medical therapies to baseline or NCI CTCAE Grade 1, except for alopecia (any grade)
7.Negative serum pregnancy test within 7 days prior to starting study treatment in premenopausal women and women < 2 years after the onset of menopause
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
1.Any prior systemic therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, immunotherapy, hormonal therapy) before Day 1 of Cycle 1 for treatment of mCRC
Patients who received prior systemic adjuvant therapy or radiotherapy for CRC are not excluded if the time interval from last administration of adjuvant therapy until disease progression is > 12 months
2.Prior radiotherapy within 28 days prior to Day 1 of Cycle 1, except palliative radiotherapy to bone lesions within 7 days prior to Day 1 of Cycle 1
3.Symptomatic CNS metastases or carcinomatous meningitis:
4.Significant cardiovascular or cerebrovascular disease within 6 months prior to Day 1 of Cycle 1
5.Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
6.Current use of anticoagulants (e.g., warfarin or any other coumadin-derivate coagulants) at therapeutic doses within 7 days prior to study drug administration. Prophylactic use of unfractioned heparin or low molecular weight heparin (LMWH) is permitted (e.g., enoxaparin 40 mg QD)
7.Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1, or anticipation of need for major surgical procedure during the course of the study or nonrecovery from side effects of any such procedure
8.History of abdominal or tracheo-oesophageal fistula or GI perforation or intra abdominal abscess within 6 months prior to Day 1
9.Clinical signs or symptoms of GI obstruction or a requirement for routine parenteral hydration, parenteral nutrition, or tube feeding
10.Evidence of abdominal free air not explained by paracentesis or recent surgical procedure
11.History of bronchopulmonary hemorrhage NCI CTCAE > Grade 2 within 4 weeks prior to Day 1 of Cycle 1
12.Severe, nonhealing or dehiscing wound, active ulcer, or untreated bone fracture
13.Known dihydropyrimidine dehydrogenase deficiency or thymidylate synthase gene polymorphism predisposing the patient for 5 FU toxicity
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method