Irinotecan Combined With Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial

Irinotecan, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in western studies. Different with westerns, squamous carcinoma is the main pathological type in china patients. The investigators then initiated a prospective phase II clinical trial with irinotecan/cisplatin as the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of the combination.

Study Overview

• Status: Unknown
• Conditions: Advanced Esophageal Squamous Carcinoma
• Intervention / Treatment: Drug: irinotecan/cisplatin

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: zhang xiaodong, MD; Phone Number: 86-01-88196175; Email: zxd0829@yahoo.com.cn
• Study Contact Backup: Name: zhang xiaotian, MD; Phone Number: 86-01-88196561; Email: zhangxtxx@gmail.com

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, no prior palliative chemotherapy; recurrence from last adjuvant chemotherapy or adjuvant radiotherapy should be longer than 6 months; no prior treatment of irinotecan as adjuvant chemotherapy, total dose of cisplatin is less than 300mg/m2 if used in adjuvant chemotherapy
• 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:

• previous treatment of palliative chemotherapy or recurrence less than 6 months from time of last adjuvant chemo-/radiotherapy
• 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: irinotecan/cisplatin; irinotecan 130mg/m2 d1 cisplatin: 30mg/m2, d1,d2 every three weeks	Drug: irinotecan/cisplatin; irinotecan 130mg/m2 d1 cisplatin 30mg/m2, d1,d2 every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival	2 year

Secondary Outcome Measures

Outcome Measure	Time Frame
response rate	1.5 months
PFS	1year
adverse events	2 year
polymorphism of UGT1A	2 year

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: January 19, 2010
• First Submitted That Met QC Criteria: January 19, 2010
• First Posted (Estimate): January 20, 2010

Study Record Updates

• Last Update Posted (Estimate): January 20, 2010
• Last Update Submitted That Met QC Criteria: January 19, 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; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Neoplasms, Squamous Cell; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Irinotecan
• Other Study ID Numbers: IP-AEC1