Randomized phase III trial of irinotecan in combination with capecitabine or fluorouracil (5-FU)/leucovorin (LV) and bevacizumab as first-line treatment in patients with metastatic colorectal cancer
- Conditions
- Metastatic colorectal cancerCancer - Bowel - Back passage (rectum) or large bowel (colon)
- Registration Number
- ACTRN12610000270011
- Lead Sponsor
- Hellenic Cooperative Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 309
1.Histologically or cytologically documented locally advanced or metastatic colorectal cancer
2.Two-dimensional measurable disease at least at one site, not previously irradiated (newly emerged disease at previously irradiated sites is acceptable). Ascites and pleural fluid are not considered measurable disease.
3. The diameter of one measurable lesion should be (at least one dimension)>=15 mm
4. No previous administration of chemotherapy (only neoadjuvant or adjuvant chemotherapy completed at least 4 months before patient enrollment in the protocol is acceptable).
5. Time between other anticancer treatments and patient enrollment should be:>= 4 weeks for major surgical intervention · >= 4 weeks for radiotherapy
6. Age>=18 years and performance status ECOG (Eastern Cooperative Oncology Group) 0-2
7. Expected life span > 3 months
8. Written informed consent
9. Adequate bone marrow function:
Hemoglobin >= 10 gr/dL
White blood cell >= 4 x 10^9/ L
Neutrophils >= 2 x 10^9/ L
Platelets >= 100 x 10^9/ L
10. Adequate hepatic and renal function
Total bilirubin <= 1.5 x UNL
Serum glutamic oxaloacetic transaminase (SGOT) <= 2.5 x UNL
Serum glutamic pyruvic transaminase (SGPT)<= 2.5 x UNL
Alkaline phosphates <= 2.5 x UNL
Creatinine <= 1.5 x UNL
11. In case of liver metastases:
Total bilirubin <= 2.5 x UNL
Serum glutamic oxaloacetic transaminase (SGOT) <= 5.0 x UNL
Serum glutamic pyruvic transaminase (SGPT) <= 5.0 x UNL
Alkaline phosphatase <= 5.0 x UNL
12. In case of bone metastases:
Alkaline phosphatase <= 10.0 x UNL
UNL: Upper normal limit of approved normal values.
1.Malignant tumors other than colorectal adenocarcinoma
2.History of other malignant disease, excluding non-melanoma cancer of the skin and in-situ cervical cancer
3.Concomitant irradiation of a measurable lesion
4.Other concomitant anticancer treatment
5.Concomitant (or in the last 4 weeks before patient enrollment) administration of other investigational drugs
6.Measurable liver lesion affecting >50% of organ function
7.Other serious concomitant diseases or compromised general condition, including major neurological and psychiatric disorders 8.Severe cardiac disease (congestive heart failure, symptomatic coronary insufficiency, history of myocardial infarction in the last 6 months, uncontrolled high-risk arterial hypertension or uncontrolled cardiac arrhythmia)
9.Uncontrolled metabolic disorders (unstable diabetes mellitus or other contraindications to corticosteroids) or serious uncontrolled active infection
10.Brain metastases and patients with bone metastases or serosal effusions as the only sites of disease
11.Inflammatory bowel disease or loss of proximal gastrointestinal tract integrity or malabsorption syndrome
12.Complete or partial bowel obstruction
13. Current history of chronic diarrhea
14.The patient had a major surgical operation in the last 4 weeks before enrollment and has not recovered yet
15.Pregnant or breastfeeding women
16.Female fertile patients not using an appropriate form of contraception
17.Patients with allo-transplanted organs 18.Inadequate follow-up because of psychological, socioeconomic, or other factors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS)[8 months from study initiation. This outcome is assessed by laboratory evaluation of hematology and biochemistry (including tumor markers), computed tomography (CT) scan or other imaging studies as indicated.]
- Secondary Outcome Measures
Name Time Method Safety of administration of each chemotherapeutic arm[1 month since the last administration of the drug. Toxicity is assessed by laboratory evaluation of hematology and biochemistry, physical examination etc.];Objective response rate (ORR)[The ORR will be assessed by imaging methods including computed tomography (CT) scan, bone scan, X-ray etc. They will be repeating after 3 cycles of XELIRI or 6 cycles of FOLFIRI, after the completion of chemotherapy and every 3 months thereafter until date of disease progression or consent withdrawal or death.];Overall Survival[5 years from study initiation]