Status:
UNKNOWN
CAPOXIRI+Bevacizumab vs. FOLFOXIRI+Bevacizumab for mCRC
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The objective is to compare the efficacy and safety of CAPOXIRI+BEV therapy versus FOLFOXIRI+BEV therapy as first-line therapy in patients with metastatic colorectal cancer (mCRC).
Detailed Description
QUATTRO-II is an open-label, multicenter, randomised, phase II study to investigate the efficacy and safety of CAPOXIRI+BEV versus FOLFOXIRI+BEV in 1st line mCRC. This study is composed two steps bec...
Eligibility Criteria
Inclusion
- Personal written informed consent is obtained after the study has been fully explained
- Histologically confirmed colon or rectal adenocarcinoma
- \*Excluding appendix cancer and anal canal cancer
- Clinically unresectable
- ≥20 years of age at enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1 (≥71 years of age: PS score of 0)
- Measurable lesion according to RECIST ver. 1.1 criteria on contrast-enhanced chest, abdominal, or pelvic (trunk) CT (required within 28 days of enrollment)
- No previous chemotherapy for colon or rectal cancer
- \*Patients with confirmed relapse ≥24 weeks after completion of post-operative adjuvant chemotherapy can be enrolled
- Ras/Braf mutation analysis at enrollment identifies Ras/Braf status as either the wild type or mutant type.
- Vital organ functions meet the following criteria within 14 days before enrollment.
- If multiple test results are available in that period, the results closest to enrollment will be used. No blood transfusions or hematopoietic factor administration will be permitted within 2 weeks before the date on which measurements are taken.
- i. Neutrophil count: ≥1,500 /cu.mm
- ii. Platelet count: ≥10.0 × 104/cu.mm
- iii. Hemoglobin concentration: ≥9.0 g/dL
- iv. Total bilirubin: ≤1.5 times upper limit of normal (ULN)
- v. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP): ≤2.5 times ULN (≤5 times ULN for metastases to liver)
- vi. Serum creatinine: ≤1.5 times ULN, or creatinine clearance: ≥30 mL/min
- vii. Urine protein: ≤2+ (if ≥3+, urine protein/creatinine ratio: \<2.0)
- UGT1A1 polymorphism is wild type or single heterozygous type -
Exclusion
- Previous radiation therapy in which ≥20% bone marrow was exposed to the radiation field
- Untreated brain metastases, spinal cord compression, or primary brain tumor
- History of central nervous system (CNS) disease (excluding asymptomatic lacunar infarction)
- Continuous systemic corticosteroid treatment is required
- Oral or parenteral (such as low molecular weight heparin) anticoagulant dose is not consistently (≥14 days) controlled. (Oral anticoagulants: conditions at high risk for bleeding, such as prothrombin time (PT)-international normalized ratio (INR) ≥3, clinically significant active bleeding (within 14 days of enrollment))
- Evidence of cardiovascular disease, cerebrovascular disorder (within 24 weeks), myocardial infarction (within 24 weeks), unstable angina pectoris, New York Heart Association (NYHA) classification ≥Grade II congestive heart failure, serious arrhythmias requiring drug therapy
- Previous treatment with an investigational drug within 28 days prior to enrollment, or participation in a study of an unapproved drug
- Any of the following comorbidities
- i. Uncontrolled hypertension
- ii. Uncontrolled diabetes mellitus
- iii. Uncontrolled diarrhea
- iv. Peripheral sensory neuropathy (≥Grade 1)
- v. Active peptic ulcer
- vi. Unhealed wound (except for suturing associated with implanted port placement)
- vii. Other clinically significant disease (such as interstitial pneumonia or renal impairment)
- Major surgical procedure within 28 days prior to study treatment initiation (such as open chest, laparoscopy, thoracoscopic surgery, laparoscopic surgery), unless only colostomy is performed; open biopsy or suturing for major trauma within 14 days of study treatment initiation; or planned major surgical procedure during the study (open chest, laparoscopy) ("major surgical procedures" does not include central venous (CV) port insertion)
- Physical defects of the upper gastrointestinal tract; malabsorption syndrome or difficulty taking oral medication
- Pregnant, breastfeeding, positive pregnancy test (women who have menstruated in the last year will be tested), or women who are unwilling to use contraception; men who are unwilling to use contraception during the study
- Active hepatitis B or C, or evidence of HIV infection
- Previous chemotherapy for other malignancies (excluding hormone therapy for breast cancer)
- Other active malignancies (synchronous malignancies, and asynchronous malignancies separated by a 5-year disease-free interval) (excluding malignancies that are expected to be completely cured, such as intramucosal carcinoma and carcinoma in situ)
- Uncontrolled venous thromboembolism (unless clinically stable, asymptomatic, or appropriately treated with an anticoagulant)
- Arterial thrombosis or arterial thromboembolism such as myocardial infarction, transient ischemic attack, or cerebrovascular attack in the last year prior to enrollment
- Complications such as intestinal paralysis, intestinal obstruction, or gastrointestinal perforation, current or within 1 year prior to enrollment
- Pleural effusion, ascites, or pericardial effusion requiring drainage
- History of hypersensitivity to fluorouracil, levofolinate, oxaliplatin, irinotecan, bevacizumab and their excipients or Chinese hamster ovary cell proteins
- History of adverse reactions to fluoropyrimidine drugs indicative of dihydropyrimidine dehydrogenase (DPD) deficiency
- Systemic treatment required for, or evidence of, infections
- Endoluminal stenting
- Otherwise unsuitable for the study in the opinion of investigators -
Key Trial Info
Start Date :
October 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2022
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04097444
Start Date
October 11 2019
End Date
August 31 2022
Last Update
October 31 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ac Medical Inc.
Chuo Ku, Tokyo, Japan, 104-0053