mFOLFIRI Combine With Nimotuzumab Second Line Chemotherapy for Squamous-cell Carcinoma of the Esophagus

NCT01486992 | Unknown Phase 2

• 1 other identifier: N+FOLFIRI-AEC-4
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

There are few studies about 2nd line treatment in advanced esophageal carcinoma (AEC), some showed that irinotecan may be effective. The investigators previous study has shown the efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase II study, the investigators would like to observe the efficacy and safety of Nimotuzumab plus Irinotecan/5FU/leucovorin as 2nd line treatment if AEC after failure to 1st treatment of PTX/DDP.

Conditions

Advanced Esophageal Carcinoma

Outcome Measures

Primary Outcomes (2)

• overall survival

  2 years

• adverse events

  2 weeks

Secondary Outcomes (3)

• progression-free survival

  1year

• response rate

  6 weeks

• disease control rate

  6 weeks

Study Arms (1)

Nimotuzumab

EXPERIMENTAL

irinotecan 180mg/m2，iv ，d1，LV 200 mg/m2 ，2h，d1，5-FU 400 mg/m2， iv，d1 5-FU 2400mg/m2，CIV，46h，q2w Nimotuzumab 200mg，iv，qw

Drug: mFOLFIRI+Nimotuzumab

Interventions

mFOLFIRI+Nimotuzumab DRUG

irinotecan 180mg/m2，iv ，d1，LV 200 mg/m2 ，2h，d1，5-FU 400 mg/m2， iv，d1 5-FU 2400mg/m2，CIV，46h，q2w Nimotuzumab 200mg，iv，qw

Nimotuzumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed esophageal squamous carcinoma,failed to 1st line treatment of paclitaxel/cisplatin
• Age 18 to 75 years old
• Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
• Life expectancy of ≥3 month
• Karnofsky performance status ≥80
• WBC\>3,500/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl，Bilirubin level \< 1.0 times ULN，Serum creatinine \<1.0 times ULN，ALT and AST\<2.5 times ULN ，AKP \< 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
• No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever\>38℃；
• Normal ECG/cardiac function
• Good compliance
• Having signed informed consent

You may not qualify if:

• More than 1 Previous systemic therapy for metastatic esophageal squamous carcinoma
• Known hypersensitivity to study drugs
• Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
• No measurable lesions, eg. pleural fluid and ascites
• Only with Other previous malignancy within 5 year, except non-melanoma skin cancer
• Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months only Brain or bone metastasis
• Chronic diarrhea
• Mentally abnormal or disable cognition,including CNS metastasis
• Pregnancy or lactation period

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Zhang Xiaodong

Beijing, Beijing Municipality, 100142, China

RECRUITING

Central Study Contacts

xiaodong zhang, MD

CONTACT

861088196175; zxd0829@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HEAD OF GI ONCOLOGY

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: December 7, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 12, 2012

Record last verified: 2011-11

Locations

CN (1)