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

Advanced Esophageal Carcinoma Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01044420
• Other study ID #: FOLFIRI-AEC2
• Status: Recruiting
• Phase: Phase 2
• First received: January 6, 2010
• Last updated: January 6, 2010
• Start date: May 2009
• Est. completion date: June 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2012
• Est. primary completion date: June 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,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 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 Carcinoma
• Esophageal Neoplasms

Intervention

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

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
Primary	adverse events		after each cycle of chemotherapy	Yes
Secondary	progression-free survival		1year	Yes
Secondary	response rate		every 6 weeks	No