Back to resultsmFOLFIRI 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
Primary Purpose
Advanced Esophageal Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
mFOLFIRI
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Esophageal Carcinoma
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
Sites / Locations
- Zhang XiaodongRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
mFOLFIRI
Arm Description
Outcomes
Primary Outcome Measures
overall survival
adverse events
Secondary Outcome Measures
progression-free survival
response rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01044420
Brief Title
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
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Peking University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Esophageal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mFOLFIRI
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
mFOLFIRI
Intervention Description
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
Primary Outcome Measure Information:
Title
overall survival
Time Frame
2 year
Title
adverse events
Time Frame
after each cycle of chemotherapy
Secondary Outcome Measure Information:
Title
progression-free survival
Time Frame
1year
Title
response rate
Time Frame
every 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhang xiaodong, MD
Phone
86-01-88196175
Email
zxd0829@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
zhang xiaotian, MD
Phone
86-01-88196561
Email
zhangxtxx@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shen lin, MD
Organizational Affiliation
peking university, school of oncology, department of GI oncology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
zhang xiaodong, MD
Organizational Affiliation
Peking University, school of oncology, department of GI oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhang Xiaodong
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhang xiaodong, MD
Phone
86-10-88196175
Email
zxd0829@yahoo.com.cn
12. IPD Sharing Statement
Learn more about this trial
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
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