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

NCT02071069 | Unknown Phase 2

• 1 other identifier: ZS-ON-05
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.

Conditions

Incurable Colorectal Cancer; RAS-wild-type

Keywords

Incurable colorectal cancer; maintenance therapy; Cetuximab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall survival

  18 Months after the last subject participate in

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

  3 Months after the last subject end the treatment

Study Arms (1)

maintenance therapy

EXPERIMENTAL

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; Drug: irinotecan; Drug: fluorouracil

Interventions

Cetuximab DRUG

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

maintenance therapy

irinotecan DRUG

180 mg/m2 IV every 2 weeks

maintenance therapy

fluorouracil DRUG

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

Also known as: 5FU

maintenance therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Tianshu Liu: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

Cetuximab; Irinotecan; Fluorouracil

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Tianshu Liu, Doctor

  Medicine-Oncology Derpartment of Zhongshan hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tianshu Liu, Doctor

CONTACT

+861368 1973 996; liu.tianshu@zs-hospital.sh.cn

yiyi yu, Master

CONTACT

+86 1381 6730 912; yu.yiyi@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Medicine-Oncology department

Study Record Dates

• First Submitted: February 19, 2014
• First Posted: February 25, 2014
• Study Start: July 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

CN (1)