Efficacy and Tolerance of Maintenance Therapy in Patients With Incurable Advanced Colorectal Cancer

Phase 2

• Conditions: Incurable Colorectal Cancer; RAS-wild-type
• Interventions: Drug: Cetuximab; Drug: irinotecan; Drug: fluorouracil

• Registration Number: NCT02071069
• Lead Sponsor: Tianshu Liu

Brief Summary

1. To evaluate efficacy, safety, and feasibility of maintenance therapy with Cetuximab combined with irinotecan or fluorouracil after Cetuximab plus irinotecan and fluorouracil(FOLFIRI) in patients with incurable colorectal cancer.

2. The relevant phase III studies reported that the progression free-survival of cetuximab combined with FOLFIRI in advanced colorectal cancer was 4.3 months up to 6.8 months.

This study assumed that the progression free-survival was 5.1 months which was not inferior to the continuous chemotherapy

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2014-02-19
• Study First Submitted QC: 2014-02-23
• Study First Posted: 2014-02-25
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-18
• Primary Completion: 2016-05
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. Patients aged ≥18 years with histologically confirmed metastatic colorectal cancer
2. Eastern Cooperative Oncology Group performance status ≤2 and
3. life expectancy of >3 months were enrolled.
4. All patients had to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)
5. None was previous exposure to Cetuximab or irinotecan .
6. Patients had to have adequate haematological (absolute neutrophil count >1.5 × 109/l; platelet count >100 × 109/l; haemoglobin >9 g/dl), hepatic [total bilirubin <1.5 × the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase <2.5 × ULN, or <5 × ULN in the case of hepatic metastases or <10 × ULN in the case of osseous metastases; alkaline phosphatase <2.5 × ULN, or <5 × ULN or <10 × ULN in the case of hepatic or osseous metastases, respectively] and renal function (creatinine clearance ≥60 ml/min)
7. All RAS were wildtype. -

Exclusion Criteria

1. Pregnant or breast-feeding women;
2. Clinically significant cardiac disease;
3. Lack of physical integrity of the upper gastrointestinal tract;
4. History of other malignancy;
5. Central nervous system metastases. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
maintenance therapy	Cetuximab	Initially, all subjects received 8 cycles of Cetuximab (400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks)plus FOLFIRI (irinotecan 180 mg/m2 IV on day 1 , leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks) . After 8 cycles or severe toxicity, patients received maintenance therapy comprising Cetuximab (250mg/m2 every week or 500mg/m2 every 2 weeks) and either irinotecan( 180 mg/m2 IV every 2 weeks) or fluorouracil arm( leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks ). In cases of unacceptable toxicity, only the related medication was stopped
maintenance therapy	irinotecan	Initially, all subjects received 8 cycles of Cetuximab (400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks)plus FOLFIRI (irinotecan 180 mg/m2 IV on day 1 , leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks) . After 8 cycles or severe toxicity, patients received maintenance therapy comprising Cetuximab (250mg/m2 every week or 500mg/m2 every 2 weeks) and either irinotecan( 180 mg/m2 IV every 2 weeks) or fluorouracil arm( leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks ). In cases of unacceptable toxicity, only the related medication was stopped
maintenance therapy	fluorouracil	Initially, all subjects received 8 cycles of Cetuximab (400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks)plus FOLFIRI (irinotecan 180 mg/m2 IV on day 1 , leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks) . After 8 cycles or severe toxicity, patients received maintenance therapy comprising Cetuximab (250mg/m2 every week or 500mg/m2 every 2 weeks) and either irinotecan( 180 mg/m2 IV every 2 weeks) or fluorouracil arm( leucovorin 400mg/m2 on day 1 , fluorouracil 400mg/m2 on day 1 and fluorouracil 2400mg/m2 civ46h every 2 weeks ). In cases of unacceptable toxicity, only the related medication was stopped

Primary Outcome Measures

Name	Time	Method
The progression free-survival	8 Months after the last subject participate in	defined as the time from enrollment to progression or death RECIST guidelines were used to define all responses after patients had received every 8 weeks of therapy

Secondary Outcome Measures

Name	Time	Method
Overall survival	18 Months after the last subject participate in	defined as the time from enrollment to death
Grade 3 and 4 adverse Events as a Measure of Safety and Tolerability	3 Months after the last subject end the treatment	Toxicity was graded according to the criteria of the National Cancer Institute Common Terminology for Adverse Events (version 4.0).

Trial Locations

Locations (1)

Zhongshan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China