Phase I trial of intraperitoneal paclitaxel combinated with mFOLFOX6 or CapeOX for colorectal cancer with peritoneal metastasis
- Conditions
- colorectal cancer with peritoneal metastasis
- Registration Number
- JPRN-UMIN000022924
- Lead Sponsor
- The University of Tokyo
- Brief Summary
The adverse events of mFOLFOX6-bevacizumab or CapeOX-bevacizumab in combination with ip PTX were considered similar to those described in previous studies of oxaliplatin-based treatment alone. The response rate was 25%. PCI score improved in 50% of the cases. Peritoneal lavage cytology turned negative during chemotherapy in all patients. One-year survival rate was 100%, progression-free survival was 8.8 months, and median survival time was 29.3 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6
Not provided
1) The patients who have another cancer in the time of entry. 2) The patients who have large amount of ascites which requires drainage more than three times per week. 3) Postoperative chemotherapy including oxaliplatin was performed within 1 year. 4) The cases with contraindication of fluorouracil, levofolinate calcium, capecitabine, oxaliplatin, bevacizumab, or paclitaxel. 5) The patients with brain tumors or brain metastases. 6) The patients with infectious diseases. 7) The patients with thrombotic diseases or embolic diseases within one year. 8) The patients requiring anticoagulant drug. 9) PT-INR>1.5 or tendency to bleed. 10) The patients who are pregnant. 11) Attending doctor decided the patients are unsuitable for this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety
- Secondary Outcome Measures
Name Time Method One year survival rate, progression free survival, response rate, the rate of improvement of peritoneal cancer index, the rate of negative conversion of the cytology of peritoneal lavage