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

Primary Purpose

Incurable Colorectal Cancer, RAS-wild-type

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Cetuximab

irinotecan

fluorouracil

About this trial

This is an interventional treatment trial for Incurable Colorectal Cancer focused on measuring Incurable colorectal cancer, maintenance therapy, Cetuximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients aged ≥18 years with histologically confirmed metastatic colorectal cancer
Eastern Cooperative Oncology Group performance status ≤2 and
life expectancy of >3 months were enrolled.
All patients had to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)
None was previous exposure to Cetuximab or irinotecan .
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)
All RAS were wildtype. -

Exclusion Criteria:

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

Sites / Locations

Zhongshan Hospital Affiliated to Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

maintenance therapy

Arm Description

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

Outcomes

Primary Outcome Measures

The progression free-survival

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

Overall survival

defined as the time from enrollment to death

Grade 3 and 4 adverse Events as a Measure of Safety and Tolerability

Toxicity was graded according to the criteria of the National Cancer Institute Common Terminology for Adverse Events (version 4.0).

Full Information

NCT ID

NCT02071069

First Posted

February 19, 2014

Last Updated

November 17, 2015

Sponsor

Tianshu Liu

1. Study Identification

Unique Protocol Identification Number

NCT02071069

Brief Title

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

Official Title

Efficacy and Tolerance of Cetuximab Combined With Irinotecan or Fluorouracil as Maintenance Therapy in Patients With RAS-wild-type Incurable Advanced Colorectal Cancer （Confirm Study）

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2013 (undefined)

Primary Completion Date

May 2016 (Anticipated)

Study Completion Date

July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Tianshu Liu

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Incurable Colorectal Cancer, RAS-wild-type

Keywords

Incurable colorectal cancer, maintenance therapy, Cetuximab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

maintenance therapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cetuximab

Intervention Description

400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks

Intervention Type

Drug

Intervention Name(s)

irinotecan

Intervention Description

180 mg/m2 IV every 2 weeks

Intervention Type

Drug

Intervention Name(s)

fluorouracil

Other Intervention Name(s)

5FU

Intervention Description

400mg/m2 on day 1 and 2400mg/m2 civ46h every 2 weeks

Primary Outcome Measure Information:

Title

The progression free-survival

Description

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

Time Frame

8 Months after the last subject participate in

Secondary Outcome Measure Information:

Title

Overall survival

Description

defined as the time from enrollment to death

Time Frame

18 Months after the last subject participate in

Title

Grade 3 and 4 adverse Events as a Measure of Safety and Tolerability

Description

Toxicity was graded according to the criteria of the National Cancer Institute Common Terminology for Adverse Events (version 4.0).

Time Frame

3 Months after the last subject end the treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients aged ≥18 years with histologically confirmed metastatic colorectal cancer Eastern Cooperative Oncology Group performance status ≤2 and life expectancy of >3 months were enrolled. All patients had to have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) None was previous exposure to Cetuximab or irinotecan . 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) All RAS were wildtype. - Exclusion Criteria: Pregnant or breast-feeding women; Clinically significant cardiac disease; Lack of physical integrity of the upper gastrointestinal tract; History of other malignancy; Central nervous system metastases. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tianshu Liu, Doctor

Phone

+861368 1973 996

liu.tianshu@zs-hospital.sh.cn

First Name & Middle Initial & Last Name or Official Title & Degree

yiyi yu, Master

Phone

+86 1381 6730 912

yu.yiyi@zs-hospital.sh.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tianshu Liu, Doctor

Organizational Affiliation

Medicine-Oncology Derpartment of Zhongshan hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongshan Hospital Affiliated to Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tianshu Liu, Doctor

liu.tianshu@zs-hospital.sh.cn

First Name & Middle Initial & Last Name & Degree

Yiyi yu, Master

12. IPD Sharing Statement

Learn more about this trial

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

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