mFOLFIRI as the Second Line Chemotherapy for Advanced Esophageal Carcinoma After Failure of 1st Line Treatment of Paclitaxel/DDP : a Phase II Single Center Prospective Clinical Trial

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 Irinotecan/5FU/leucovorin as 2nd line treatment if AEC after failure to 1st treatment of PTX/DDP.

Study Overview

• Status: Unknown
• Conditions: Advanced Esophageal Carcinoma
• Intervention / Treatment: Drug: mFOLFIRI

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Zhang Xiaodong
      • Contact: zhang xiaodong, MD; Phone Number: 86-10-88196175; Email: zxd0829@yahoo.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Having signed informed consent
• Age 18 to 70 years old
• Histologically confirmed esophageal squamous carcinoma,failed to 1st line treatment of paclitaxel/cisplatin
• Unresectable recurrent or metastatic disease
• 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)
• Karnofsky performance status ≥70
• Life expectancy of ≥3 month
• No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
• ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
• Serum AKP < 2.5 times ULN (within 7 days before enrollment)
• Serum creatinine <1.0 times ULN (within 7 days before enrollment)
• Bilirubin level < 1.0 times ULN (within 7 days before enrollment)
• WBC>4,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl(within 7 days before enrollment)
• No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃；
• Good compliance

Exclusion Criteria:

• More than 1 Previous systemic therapy for metastatic esophageal squamous carcinoma
• Known hypersensitivity to irinotecan
• Only with Brain or bone metastasis
• 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
• Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
• Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months or
• Pregnancy or lactation period
• Other previous malignancy within 5 year, except non-melanoma skin cancer
• Chronic diarrhea
• Mentally abnormal or disable cognition,including CNS metastasis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mFOLFIRI	Drug: mFOLFIRI; mFOLFIRI irinotecan 130-150mg/m2 iv d1 LV 200 mg/m2 iv 2h d1 5-FU 400 mg/m2 IV d1 5-FU 2.4-3 g/m2 CI 46-h repeat every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival	2 year
adverse events	after each cycle of chemotherapy

Secondary Outcome Measures

Outcome Measure	Time Frame
progression-free survival	1year
response rate	every 6 weeks

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Study Chair: shen lin, MD, Peking University, School of Oncology, Department of GI oncology; Principal Investigator: zhang xiaodong, MD, Peking University, School of Oncology, Department of GI oncology

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: January 6, 2010
• First Submitted That Met QC Criteria: January 6, 2010
• First Posted (Estimate): January 7, 2010

Study Record Updates

• Last Update Posted (Estimate): January 7, 2010
• Last Update Submitted That Met QC Criteria: January 6, 2010
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Carcinoma; Esophageal Neoplasms
• Other Study ID Numbers: FOLFIRI-AEC2