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
Conditions
Advanced Esophageal Carcinoma
Conditions: official terms
Esophageal Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: mFOLFIRI
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Zhang Xiaodong
Beijing, Beijing, China
Status: Recruiting
Contact: zhang xiaodong, MD - 86-10-88196175 - zxd0829@yahoo.com.cn
Start Date
May 2009
Completion Date
June 2012
Sponsors
Peking University
Source
Peking University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page