Metastatic Colorectal CancerPhase 2NCT03222089
Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC
A Phase 2 study testing Irinotecan, Oxaliplatin and Levoleucovorin in people with Metastatic Colorectal Cancer, run by Fujian Cancer Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Irinotecan, Oxaliplatin and Levoleucovorin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2017to 20 Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Irinotecan, Oxaliplatin, Levoleucovorin, 5-FU, GM-CSF
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
Also called CPT11, Camptosar
Irinotecan 165 mg/m² 1-hour IV day 1
OxaliplatinDrug
Also called L-OHP, Eloxatin
oxaliplatin 85 mg/m² 2-hours IV day 1
LevoleucovorinDrug
Also called Fusilev, l-LV
Levoleucovorin 200 mg/m² 2-hours IV day 1
5-FUDrug
Also called 5-Fluorouracil
5-FU 2800 mg/m² 46-hours flat continuous infusion IV
GM-CSFDrug
Also called Granulocyte Macrophage Colony Stimulating Factor
GM-CSF 150ug s.c. d3-7 , Repeated every 4 weeks.
IL-2Drug
Also called Interleukin-2
Interleukin-2 100MIU s.c. d8-14 and d17-d28, Repeated every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| FOLFOXIGIL | Experimental | 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. Receives: Drug: Irinotecan; Drug: Oxaliplatin; Drug: Levoleucovorin; Drug: 5-FU; Drug: GM-CSF; Drug: IL-2 |
| FOLFOXIRI | Active comparator | 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. Receives: Drug: Irinotecan; Drug: Oxaliplatin; Drug: Levoleucovorin; Drug: 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: PFS rate at 10 months from study entry
Secondary outcomes (5)
Response rate
CR + PR rate according to the RECIST version 1.1 guidelines.
Measured: up to 12 months
Toxicity
Toxicity assessed using the NCI common toxicity criteria, version 4.01
Measured: up to 12 months
Overall survival time
OS was calculated from the date of randomization to death from any cause.
Measured: Up to 30 months
Progression free survival
PFS was calculated from the day of randomization to the date of first documented progression, or death from any cause.
Measured: Up to 18 months
Quality of life (QLQ C30)
Scores according to EORTC QLQ-C30 scoring manual
Measured: Quality of life was evaluated every 2 weeks during treatment and every 8 weeks during follow up (36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start20 Jul 2017 (estimated)
- Primary completion20 Jul 2019 (estimated)
- Study completion20 Jul 2020 (estimated)
Why it stopped: Another study enrolling the similar group of patient are ongoing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rongbo Lin, MD, Study chair, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222089
- Sponsor's protocol ID
- FNF-006
- Status last verified
- Mar 2018
- First submitted
- 3 Jul 2017
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03222089
- Acronym / sponsor ID
- FNF-006
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Another study enrolling the similar group of patient are ongoing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 20 Jul 2017 (estimated)
- Primary completion
- 20 Jul 2019 (estimated)
- Study completion
- 20 Jul 2020 (estimated)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOXIGIL | Experimental | Drug: Irinotecan, Drug: Oxaliplatin, Drug: Levoleucovorin, Drug: 5-FU, Drug: GM-CSF, Drug: IL-2The 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. |
| FOLFOXIRI | Active comparator | Drug: Irinotecan, Drug: Oxaliplatin, Drug: Levoleucovorin, Drug: 5-FUIrinotecan 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IrinotecanAlso: CPT11, CamptosarIrinotecan 165 mg/m² 1-hour IV day 1 | Drug | FOLFOXIGIL, FOLFOXIRI |
| OxaliplatinAlso: L-OHP, Eloxatinoxaliplatin 85 mg/m² 2-hours IV day 1 | Drug | FOLFOXIGIL, FOLFOXIRI |
| LevoleucovorinAlso: Fusilev, l-LVLevoleucovorin 200 mg/m² 2-hours IV day 1 | Drug | FOLFOXIGIL, FOLFOXIRI |
| 5-FUAlso: 5-Fluorouracil5-FU 2800 mg/m² 46-hours flat continuous infusion IV | Drug | FOLFOXIGIL, FOLFOXIRI |
| GM-CSFAlso: Granulocyte Macrophage Colony Stimulating FactorGM-CSF 150ug s.c. d3-7 , Repeated every 4 weeks. | Drug | FOLFOXIGIL |
| IL-2Also: Interleukin-2Interleukin-2 100MIU s.c. d8-14 and d17-d28, Repeated every 4 weeks. | Drug | FOLFOXIGIL |
Primary outcome
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.
5 secondary outcomes
Response rate
Time frame: up to 12 months
Toxicity
Time frame: up to 12 months
Overall survival time
Time frame: Up to 30 months
Progression free survival
Time frame: 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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rongbo Lin, MD study chair
Fujian Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irinotecan, Oxaliplatin and Levoleucovorin in people with Metastatic Colorectal Cancer, run by Fujian Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) rate at 10 months (time frame: PFS rate at 10 months from study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.