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

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）

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

Study Overview

• Status: Unknown
• Conditions: Incurable Colorectal Cancer; RAS-wild-type
• Intervention / Treatment: Drug: Cetuximab; Drug: irinotecan; Drug: fluorouracil

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital Affiliated to Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: maintenance therapy; 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

Drug: Cetuximab; 400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks; Drug: irinotecan; 180 mg/m2 IV every 2 weeks; Drug: fluorouracil; 400mg/m2 on day 1 and 2400mg/m2 civ46h every 2 weeks; Other Names: 5FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 Months after the last subject participate in

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	defined as the time from enrollment to death	18 Months after the last subject participate in
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).	3 Months after the last subject end the treatment

Collaborators and Investigators

• Sponsor: Tianshu Liu

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ANTICIPATED): May 1, 2016
• Study Completion (ANTICIPATED): July 1, 2016

Study Registration Dates

• First Submitted: February 19, 2014
• First Submitted That Met QC Criteria: February 23, 2014
• First Posted (ESTIMATE): February 25, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): November 18, 2015
• Last Update Submitted That Met QC Criteria: November 17, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Cetuximab; maintenance therapy; Incurable colorectal cancer
• 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; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Topoisomerase I Inhibitors; Fluorouracil; Irinotecan; Cetuximab
• Other Study ID Numbers: ZS-ON-05