Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC

• Status: Withdrawn
• Trial end date: 2020-07-20
• Target enrollment: 0
• Participant gender: All

Summary

A randomized phase II trial of FOLFOXIRI in Combination With GM-CSF and IL-2 (FOLFOXIGIL) Versus FOLFOXIRI as First-line Treatment for Patients With Metastatic Colorectal Cancer.

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

Details

• Lead Sponsor: Fujian Cancer Hospital
• Treatments: Fluorouracil; Interleukin-2; Irinotecan; Leucovorin; Levoleucovorin; Molgramostim; Oxaliplatin; Sargramostim

Criteria

Inclusion Criteria:

• histological or cytological documentation of adenocarcinoma of the colon or rectum.

• unresectable metastatic disease

• age 18 to 75 years

• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower if age 70 years or younger or ECOG performance status of 0 if age 71 to 75 years

• at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria measured within 4 weeks prior to registration.

• no previous chemotherapy or target therapy for metastatic disease (adjuvant chemotherapy for non-metastatic disease is allowed if terminated more than 6 months ago).

• adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:

• Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet count ≥ 100 x109/ L, hemoglobin (Hb) ≥9g/ dL.

• Total bilirubin ≤ 1.5 x the upper limit of normal (ULN).

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.

• Alkaline phosphatase limit ≤ 5x ULN.

• Amylase and lipase ≤ 1.5 x the ULN.

• Serum creatinine ≤ 1.5 x the ULN.

• Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min.

Exclusion Criteria:

• previous palliative chemotherapy for metastatic disease

• previous chemotherapy including irinotecan or oxaliplatin

• symptomatic cardiac disease, myocardial infarction in the last 24 months or uncontrolled arrhythmia

• active infections

• pregnancy or lactation at the time of study entry.

• inflammatory bowel disease

• major autoimmune diseases

• acquired immunosuppression (AIDS or major immunosuppressive agents)