Colorectal Cancer
Conditions
Interventions
Controlled:Raltitrexed and Irinotecan
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with a histological or cytological verified adenocarcinoma of the colon or rectum with metastatic cancer; 2. aged 18 years or older; 3. Life expectancy >=12 weeks; 4. ECOG performance status 0-2; 5. No second-line treatment, and failure after prior fluorouracil or its derivatives-based (fluoropyrimidine or Capecitabine or S-1, with or without oxaliplatin) chemotherapy as first-line therapy for metastatic disease or in the adjuvant setting (Relapse within 6 months of adjuvant therapy); 6. At least 2 weeks since prior chemotherapy and 4 weeks since prior radiotherapy, prior radiotherapy to non-target lesions allowed and no prior radiotherapy to target lesions unless disease progression is documented within the radiation port; 7. Measurable lesion (>=1 cm) as assessed by CT scan or MRI according to RECIST criteria (version 1.0); 8. Adequate haematological, hepatic, and renal functions defined as the following within 1 week before enrollment:count (ANC) >=1,500/mm^3, Platelet count >=75,000/mm^3, Hemoglobin >=9 g/dL ,Serum bilirubin <=1.5 times upper limit of normal (ULN), AST and ALT <=2.5 times ULN (< 5 times ULN if liver metastases present), Serum creatinine <=1.5 times ULN; 9. Signed written Informed Consent; 10. No planned target-agent in the second line therapy in the study period; 11. No prior Raltitrexed or irinotecan agent treatment.
Exclusion criteria
Exclusion criteria: 1. Patients with serious impared hepatic or renal functions; with diagnosed angina or myocardial infarction 5 years are allowed; 3. Patients with untreated or symptomatic CNS metastases; 4. Patients who have any severe and/or uncontrolled medical conditions or active infections,(=38? fever causing by infection); 5. Patients with severe significant medical or surgical conditions, that might prevent the patient from being treated with the protocoled therapy; 6. Women who are pregnant or breastfeeding, and women and partners of women of childbearing potential who are not using effective contraception; 7. Active inflammatory bowel disease or other bowel disease causing long-term chronic diarrhoea, or total or obvious bowel obstruction; 8. Contraindications to Raltitrexed or Irinotecan; 9. Patients unsuitable to enroll considered by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Tumor response;Quality of life;Toxicity, Adverse events and Serious Adverse Event; | — |
Countries
China
Contacts
Public ContactJi-Yan Liu
Outcome results
None listed