A phase II study to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802)
- Conditions
- patients with advanced/recurrent colon cancer who cannot undergo common protocol
- Registration Number
- JPRN-UMIN000002182
- Lead Sponsor
- Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
- Brief Summary
The ORR was 36.6% [95% confidence interval (CI) 22.1-53.1%], median PFS was 9.4 months (95 CI 7.4-17.7 months), and median OS was 24.0 months (95% CI 19.9 months-not reached).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 41
Not provided
1) ECOG PS 3-4 2) with a brain tumor or brain metastasis 3) with double cancer diagnosed within 5 years except for basal cell Carcinoma, CIS of portion, and/or CIS of digestive tract treated curatively 4) with a symptom of neuro-vascular disorder on the brain 5) without surgical treatment, open biopsy, and/or suturing of injury 6) with plans of surgical operation during this regimen 7) with easy bleeding and/or coagulation disorder 8) with a history of thrombosis 9) with an ulcer on the digestive tracts which is uncontrollable 10) with inflammation of abdominal organs 11) with a disorder of the kidney which needs some therapies 12) with an uncontrolled hypertension 13) with a severe allergy to fluorouracil. Levohorinate calcium 14)patients with a lack of enzyme; DPD (dihydropyridine dehydrogenase) or with adverse events due to fluoropyrimidine 15) with an uncontrollable diarrhea 16) with interstitial pneumonia or pulmonary fibrosis 17) patients who need immuno-suppressive medicines after an organ transplantation 18) with an uncontrollable infection 19) pregnant females, nursing mothers, or pregnancy test-positive females 20) males who do not protect against pregnancy 21) patients whose doctor cannot register for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method