Clinical trial NCT01044420: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Esophageal Carcinoma
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2010-01-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: overall survival
timeFrame: 2 year
measure: adverse events
timeFrame: after each cycle of chemotherapy
Secondary outcomes:
measure: progression-free survival
timeFrame: 1year
measure: response rate
timeFrame: every 6 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhang Xiaodong
state: Beijing
Study officials:
affiliation: peking university, school of oncology, department of GI oncology
name: shen lin, MD
role: STUDY_CHAIR
affiliation: Peking University, school of oncology, department of GI oncology
name: zhang xiaodong, MD
role: PRINCIPAL_INVESTIGATOR
References: