- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03222089
Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350014
- Rongbo Lin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: FOLFOXIGIL
The FOLFOXIGIL chemoimmunotherapy regimen is composed by FOLFOXIRI chemotherapy and the immunotherapy of GM-CSF and IL-2. FOLFOXIRI: Irinotecan 165 mg/m² + oxaliplatin 85 mg/m² + Levoleucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1, repeated every 2 weeks. GM-CSF 150ug s.c. d3-7; Interleukin-2 100MIU s.c. d8-14 and d17-d28, Repeated every 4 weeks. Treatment will be administered until progression, patients' withdrawal of consent, unacceptable toxicity. |
Irinotecan 165 mg/m² 1-hour IV day 1
Other Names:
oxaliplatin 85 mg/m² 2-hours IV day 1
Other Names:
Levoleucovorin 200 mg/m² 2-hours IV day 1
Other Names:
5-FU 2800 mg/m² 46-hours flat continuous infusion IV
Other Names:
GM-CSF 150ug s.c.
d3-7 , Repeated every 4 weeks.
Other Names:
Interleukin-2 100MIU s.c.
d8-14 and d17-d28, Repeated every 4 weeks.
Other Names:
|
ACTIVE_COMPARATOR: FOLFOXIRI
Irinotecan 165 mg/m² + oxaliplatin 85 mg/m² + Levoleucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1, Repeated every 2 weeks. Treatment will be administered until progression, patients' withdrawal of consent, unacceptable toxicity. |
Irinotecan 165 mg/m² 1-hour IV day 1
Other Names:
oxaliplatin 85 mg/m² 2-hours IV day 1
Other Names:
Levoleucovorin 200 mg/m² 2-hours IV day 1
Other Names:
5-FU 2800 mg/m² 46-hours flat continuous infusion IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS) rate at 10 months
Time Frame: PFS rate at 10 months from study entry
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: up to 12 months
|
CR + PR rate according to the RECIST version 1.1 guidelines.
|
up to 12 months
|
Toxicity
Time Frame: up to 12 months
|
Toxicity assessed using the NCI common toxicity criteria, version 4.01
|
up to 12 months
|
Overall survival time
Time Frame: Up to 30 months
|
OS was calculated from the date of randomization to death from any cause.
|
Up to 30 months
|
Progression free survival
Time Frame: Up to 18 months
|
PFS was calculated from the day of randomization to the date of first documented progression, or death from any cause.
|
Up to 18 months
|
Quality of life (QLQ C30)
Time Frame: Quality of life was evaluated every 2 weeks during treatment and every 8 weeks during follow up (36 months)
|
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)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Topoisomerase Inhibitors
- Micronutrients
- Vitamins
- Topoisomerase I Inhibitors
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Leucovorin
- Irinotecan
- Levoleucovorin
- Sargramostim
- Interleukin-2
- Molgramostim
Other Study ID Numbers
- FNF-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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