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

NCT ID: NCT01044420

Last Updated: 2010-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-06-30

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

Conditions

Advanced Esophageal Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

mFOLFIRI

Group Type: EXPERIMENTAL

mFOLFIRI

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Peking University, School of Oncology, Department of GI oncology

Principal Investigators

shen lin, MD

Role: STUDY_CHAIR

peking university, school of oncology, department of GI oncology

zhang xiaodong, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University, school of oncology, department of GI oncology

Locations

Zhang Xiaodong

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

zhang xiaodong, MD

Role: CONTACT

zxd0829@yahoo.com.cn

86-01-88196175

zhang xiaotian, MD

Role: CONTACT

zhangxtxx@gmail.com

86-01-88196561

Facility Contacts

zhang xiaodong, MD

Role: primary

zxd0829@yahoo.com.cn

86-10-88196175

Other Identifiers

FOLFIRI-AEC2

Identifier Type: -

Identifier Source: org_study_id