Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Second-line Treatment in Advanced Colorectal Cancer Patients

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to compare the efficacy and safety of two-weekly RAILIRI regimen with FOLFIRI regimen in the treatment of advanced colorectal cancer patients in the second-line setting.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Camptothecin; Fluorouracil; Irinotecan; Leucovorin; Raltitrexed

Criteria

Inclusion Criteria:

• aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma

• Eastern Cooperative Oncology Group performance status of 0 to 1

• life expectancy of ≥ 3 months

• patients who had failed first-line treatment with either XELOX (capecitabine combined with oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin)

• at least one measurable disease lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria

• have adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

• patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction

• patients with symptomatic brain metastases

• active clinical severe infection

• previously received irinotecan or raltitrexed

• dihydropyrimidine dehydrogenase (DPD) enzyme adequate