Phase II clinical trial of the first-line Stop-and-Go modified FOLFOX6 and bevacizmab for patients with unresectable/recurrent colorectal cancer

UMIN ID: UMIN000001233

Registered date:07/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: colorectal cancer
• Date of first enrollment: 2007/08/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): After 8 cycles of modified FOLFOX 6 with bevacizmab, patients receive sLV5FU2 with bevacizumab (until 8 cycles are completed or disease progression). And then, patients receive modified FOLFOX6 with bevacizmab (until 8 cycles are completed or disease progression.)

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: The incidence of adverse events Time to treatment failure Progression-free survival Overall survival The incidence of grade 3 neurotoxicity

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) active other malignancies 2) history of the severe drug hypersensitivity 3) clinically significant infectious disease(body temperature less than 38.0 degrees) 4) severe complications (ileus, bowel obstruction, interstitial lung disease, pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, hepatic failure and so on) 5) uncontrollable hypertension 6) urinary protein (more than 1+) 7) Patients who have abnormal findings on ECG and need any treatment (within 2 weeks before the registration.) 8) Moderate/severe pleural effusion or ascites 9) Symptomatic brain metastasis 10) Any significant bleedings 11) Evidence of bleeding diathesis 12) History of thoromboembolitic disease 13) Uncontrolled watery diarrhea. Watery colostomy output without trouble with patient's daily living is allowed. 14) Surgical procedure within 4 weeks before registration (the implanted central venous port is allowed.) 15) Patient who underwents the implantation of the central venous port within a day prior to start of study drugs. 16) Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant, men who don't intend to have protected intercourse. 17) Any other cases who are regarded as Inadequate for study enrollment by the attending doctors.

Related Information

• Primary Sponsor: Mlnlstry of health, Labour and Welfare
• Source(s) of Monetary Support: None