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Irinotecan Combined With Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial

Primary Purpose

Advanced Esophageal Squamous Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
irinotecan/cisplatin
Sponsored by
Peking University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Esophageal Squamous Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having signed informed consent
  • Age 18 to 70 years old
  • Histologically confirmed esophageal squamous carcinoma, no prior palliative chemotherapy; recurrence from last adjuvant chemotherapy or adjuvant radiotherapy should be longer than 6 months; no prior treatment of irinotecan as adjuvant chemotherapy, total dose of cisplatin is less than 300mg/m2 if used in adjuvant chemotherapy
  • 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:

  • previous treatment of palliative chemotherapy or recurrence less than 6 months from time of last adjuvant chemo-/radiotherapy
  • 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

irinotecan/cisplatin

Arm Description

irinotecan 130mg/m2 d1 cisplatin: 30mg/m2, d1,d2 every three weeks

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

PFS
response rate
adverse events
polymorphism of UGT1A

Full Information

First Posted
January 19, 2010
Last Updated
January 19, 2010
Sponsor
Peking University
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1. Study Identification

Unique Protocol Identification Number
NCT01051765
Brief Title
Irinotecan Combined With Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial
Official Title
Irinotecan Combined With Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
August 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Peking University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Irinotecan, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in western studies. Different with westerns, squamous carcinoma is the main pathological type in china patients. The investigators then initiated a prospective phase II clinical trial with irinotecan/cisplatin as the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of the combination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Esophageal Squamous 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
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
irinotecan/cisplatin
Arm Type
Experimental
Arm Description
irinotecan 130mg/m2 d1 cisplatin: 30mg/m2, d1,d2 every three weeks
Intervention Type
Drug
Intervention Name(s)
irinotecan/cisplatin
Intervention Description
irinotecan 130mg/m2 d1 cisplatin 30mg/m2, d1,d2 every 3 weeks
Primary Outcome Measure Information:
Title
overall survival
Time Frame
2 year
Secondary Outcome Measure Information:
Title
PFS
Time Frame
1year
Title
response rate
Time Frame
1.5 months
Title
adverse events
Time Frame
2 year
Title
polymorphism of UGT1A
Time Frame
2 year

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, no prior palliative chemotherapy; recurrence from last adjuvant chemotherapy or adjuvant radiotherapy should be longer than 6 months; no prior treatment of irinotecan as adjuvant chemotherapy, total dose of cisplatin is less than 300mg/m2 if used in adjuvant chemotherapy 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: previous treatment of palliative chemotherapy or recurrence less than 6 months from time of last adjuvant chemo-/radiotherapy 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
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

Irinotecan Combined With Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial

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