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

Advanced Esophageal Squamous Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01051765
• Other study ID #: IP-AEC1
• Status: Recruiting
• Phase: Phase 2
• First received: January 19, 2010
• Last updated: January 19, 2010
• Start date: August 2009
• Est. completion date: August 2012

Study information

• Verified date: May 2009
• Source: Peking University
• Contact: zhang xiaodong, MD
• Phone: 86-01-88196175
• Email: zxd0829[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Esophageal Squamous Carcinoma
• Carcinoma, Squamous Cell

Intervention

Drug:
• irinotecan/cisplatin
irinotecan 130mg/m2 d1 cisplatin 30mg/m2, d1,d2 every 3 weeks

Locations

Country	Name	City	State
China	Zhang Xiaodong	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		2 year	No
Secondary	PFS		1year	No
Secondary	response rate		1.5 months	No
Secondary	adverse events		2 year	Yes
Secondary	polymorphism of UGT1A		2 year	Yes