Clinical trial NCT03222089: Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2017-07-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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)

Primary outcomes:
measure: Progression-free survival (PFS) rate at 10 months
timeFrame: PFS rate at 10 months from study entry
Secondary outcomes:
measure: Response rate
timeFrame: up to 12 months
measure: Toxicity
timeFrame: up to 12 months
measure: Overall survival time
timeFrame: Up to 30 months
measure: Progression free survival
timeFrame: Up to 18 months
measure: Quality of life (QLQ C30)
timeFrame: Quality of life was evaluated every 2 weeks during treatment and every 8 weeks during follow up (36 months)
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Rongbo Lin
state: Fujian
Study officials:
affiliation: Fujian Cancer Hospital
name: Rongbo Lin, MD
role: STUDY_CHAIR
References: