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

Metastatic Colorectal Cancer Clinical Trial

Official title:

FOLFOXIRI in Combination With GM-CSF and IL-2 (FOLFOXIGIL) Versus FOLFOXIRI as First-line Treatment for Patients With Metastatic Colorectal Cancer: a Phase II Trial by the FNF Team.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03222089
• Other study ID #: FNF-006
• Status: Withdrawn
• Phase: Phase 2
• First received: July 3, 2017
• Last updated: March 23, 2018
• Start date: July 20, 2017
• Est. completion date: July 20, 2020

Study information

• Verified date: March 2018
• Source: Fujian Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The triple drug regimen FOLFOXIRI (irinotecan, oxaliplatin, fluorouracil, and folinate) for the first-line treatment of metastatic colorectal cancer has shown a significant increase in response rate and overall survival compared to FOLFIRI and FOLFOX. The combination of GOLF chemotherapy with GM-CSF and IL-2（GOLFIG regimen） has shown more active than the standard FOLFOX chemotherapy in first-line mCRC patients，through the chemoimmunomodulatory effects. SO the FOLFOXIGIL chemoimmunotherapy regimen was designed with the same principle to evaluate the antitumor frontline efficacy in comparison with the FOLFOXIRI regimen as first-line treatment of mCRC patients. This is a multicenter, randomized controlled, double-blind, phase II trial.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 20, 2020
• Est. primary completion date: July 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Irinotecan
Irinotecan 165 mg/m² 1-hour IV day 1
• Oxaliplatin
oxaliplatin 85 mg/m² 2-hours IV day 1
• Levoleucovorin
Levoleucovorin 200 mg/m² 2-hours IV day 1
• 5-FU
5-FU 2800 mg/m² 46-hours flat continuous infusion IV
• GM-CSF
GM-CSF 150ug s.c. d3-7 , Repeated every 4 weeks.
• IL-2
Interleukin-2 100MIU s.c. d8-14 and d17-d28, Repeated every 4 weeks.

Locations

Country	Name	City	State
China	Rongbo Lin	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS) rate at 10 months	PFS by investigator-reported measurements according to CT image. PFS was calculated from the day of randomization to the date of first documented progression disease (PD) , or death from any cause.; PD was defined as Overall Response by RECIST criteria v1.1 according to CT image.	PFS rate at 10 months from study entry
Secondary	Response rate	CR + PR rate according to the RECIST version 1.1 guidelines.	up to 12 months
Secondary	Toxicity	Toxicity assessed using the NCI common toxicity criteria, version 4.01	up to 12 months
Secondary	Overall survival time	OS was calculated from the date of randomization to death from any cause.	Up to 30 months
Secondary	Progression free survival	PFS was calculated from the day of randomization to the date of first documented progression, or death from any cause.	Up to 18 months
Secondary	Quality of life (QLQ C30)	Scores according to EORTC QLQ-C30 scoring manual	Quality of life was evaluated every 2 weeks during treatment and every 8 weeks during follow up (36 months)