SOX Sequential S-1 in Advanced Biliary Tract Carcinoma(BTC)and Pancreatic Cancer
Primary Purpose
Biliary Tract Cancer, Periampullary Adenocarcinoma, Pancreatic Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SOX sequential S-1
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Cancer focused on measuring palliative chemotherapy, ORR, PFS, OS, safety, advanced Biliary Tract Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Written Informed consent
- Male or female patients >=18 years old
- Histologically or cytologically confirmed diagnosis of adenocarcinoma
- No previous treatment is allowed including chemotherapy, radiotherapy,immunotherapy or others.
- In case the patient received adjuvant therapy before, enrollment is allowed if the adjuvant therapy does not contain L-OHP or S-1 and at the same time, the last day of chemotherapy is ≥180 days before screening.
- Target lesion more than 1cm in diameter by enhanced CT or MRI 21 days before enrollment
The laboratory parameter meets the following criteria 7 days before enrollment
- Hemoglobin ≥90g/L
- Absolute neutrophil count≥1.5×10^9/L, platelets 100×10^9/L;
- ALT and AST≤2.5 ULN(in case of the patients with liver metastasis,ALT and AST≤5.0 ULN)
- ALP ≤2.5 ULN (in case of the patients with liver metastasis,≤5.0 ULN)
- Total Serum bilirubin ≤1.5 ULN
- Serum creatinine ≤1.0 ULN
- serum albumin(ALB)≥30g/L;
- can tolerate oral drug administration;
- KPS ≥70
- Estimated survival ≥90 days
- Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of enrollment and must be willing to use adequate methods of contraception during the study and for 30 days after last study durg administration.
Exclusion Criteria:
- Known sensitivity to 5-HT3 antagonist and hypersensitivity to the other treatment agents including irinotecan, cisplatin and octreotide lar
- Any participation in trials simultaneously or 4 weeks before screening.
- 15 days prior to enrollment, received a blood transfusion, blood products and hematopoietic growth factors such as G-CSF.
- Undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such surgery.
- Uncontrolled severe diarrhea
- Uncontrolled active infection (fever ≥38 degrees due to infection)
- S-1 oral drug administration difficulty due to difficulty swallowing, complete or incomplete digestive tract obstruction, gastrointestinal active bleeding, perforation;
- severe hepatopathy including active hepatitis and hepatic cirrhosis, renal dysfunction, severe pulmonary diseases including interstitial pneumonia, pulmonary fibrosis and severe pulmonary emphysema, uncontrolled diabetes, hypertension and other chronic systematic diseases.
- Chronic treatment with steroids.(In case of the patients with short-term use of steroids, the enrollment is permitted if the administration is stopped 2 weeks before screening.)
- confirmed or suspected CNS metastasis
- the history of peripheral nervous system impairment, obvious mental disorder or CNS impairment
- clinically significant heart disease, including congestive heart failure, symptomatic coronal heart disease, arrythmia uncontrolled by medication and acute myocardial infarction or cardiac insufficiency within 6 months before screening
- Drainage of pleural effusion, peritoneal effusion and pericardial effusion
- pregnant women or women in lactation period
- Fertile male or women of child-bearing potential refuse to take highly effective methods of birth control
- Incidence of other second primary malignant tumors within 5 years, except for cured basal cell carcinoma and cervical carcinoma in situ.
- patients of legal incapacity or who have the potential of influence the whole trial due to medical or ethic reasons.
- Other patients who are not eligible to the trial under investigators' discretion
Sites / Locations
- Beijing Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SOX sequential S-1
Arm Description
4-6 cycles of SOX followed by S-1 monotherapy until disease progression
Outcomes
Primary Outcome Measures
Objective response rate for SOX sequential S-1
The primary endpoint is objective response rate,which equals CR+PR.
Secondary Outcome Measures
Overall Survival
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost
progression free survival
PFS means that from the first dose of treatment drug to disease progression or death or lost, the follow-up visit will be performed every 6 weeks till progression or death or lost
1 year survival rate
the follow-up visit of survival will be performed every 3 months till 1 year
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Full Information
NCT ID
NCT01811277
First Posted
March 11, 2013
Last Updated
March 13, 2013
Sponsor
Peking University
Collaborators
Taiho Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01811277
Brief Title
SOX Sequential S-1 in Advanced Biliary Tract Carcinoma(BTC)and Pancreatic Cancer
Official Title
Phase II Exploratory Study of S-1 Combined With Oxaliplatin Sequential S-1 Single-agent First-line Treatment of Unresectable Metastatic or Locally Advanced Biliary System, Periampullary Cancer and Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
Collaborators
Taiho Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an exploratory, single-armed, open label study on the efficacy and safety of sequential S-1 therapy after SOX in unresectable metastatic or locally advanced biliary system or periampullary cancer or pancreatic cancer patients. The primary endpoint is Objective response rate and secondary endpoint is progression free survival , overall survival ,1 year survival rate and safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Cancer, Periampullary Adenocarcinoma, Pancreatic Cancer
Keywords
palliative chemotherapy, ORR, PFS, OS, safety, advanced Biliary Tract Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SOX sequential S-1
Arm Type
Experimental
Arm Description
4-6 cycles of SOX followed by S-1 monotherapy until disease progression
Intervention Type
Drug
Intervention Name(s)
SOX sequential S-1
Other Intervention Name(s)
S-1/oxaliplatin
Intervention Description
4-6 cycles SOX followed by S-1 monotherapy until disease progression
S-1: 40~60mg bid,po, d1~14 (S-1:BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) oxaliplatin:130mg/m2,iv drip for 2h,d1
Primary Outcome Measure Information:
Title
Objective response rate for SOX sequential S-1
Description
The primary endpoint is objective response rate,which equals CR+PR.
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost
Time Frame
2 years
Title
progression free survival
Description
PFS means that from the first dose of treatment drug to disease progression or death or lost, the follow-up visit will be performed every 6 weeks till progression or death or lost
Time Frame
1 year
Title
1 year survival rate
Description
the follow-up visit of survival will be performed every 3 months till 1 year
Time Frame
1 year
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written Informed consent
Male or female patients >=18 years old
Histologically or cytologically confirmed diagnosis of adenocarcinoma
No previous treatment is allowed including chemotherapy, radiotherapy,immunotherapy or others.
In case the patient received adjuvant therapy before, enrollment is allowed if the adjuvant therapy does not contain L-OHP or S-1 and at the same time, the last day of chemotherapy is ≥180 days before screening.
Target lesion more than 1cm in diameter by enhanced CT or MRI 21 days before enrollment
The laboratory parameter meets the following criteria 7 days before enrollment
Hemoglobin ≥90g/L
Absolute neutrophil count≥1.5×10^9/L, platelets 100×10^9/L;
ALT and AST≤2.5 ULN(in case of the patients with liver metastasis,ALT and AST≤5.0 ULN)
ALP ≤2.5 ULN (in case of the patients with liver metastasis,≤5.0 ULN)
Total Serum bilirubin ≤1.5 ULN
Serum creatinine ≤1.0 ULN
serum albumin(ALB)≥30g/L;
can tolerate oral drug administration;
KPS ≥70
Estimated survival ≥90 days
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of enrollment and must be willing to use adequate methods of contraception during the study and for 30 days after last study durg administration.
Exclusion Criteria:
Known sensitivity to 5-HT3 antagonist and hypersensitivity to the other treatment agents including irinotecan, cisplatin and octreotide lar
Any participation in trials simultaneously or 4 weeks before screening.
15 days prior to enrollment, received a blood transfusion, blood products and hematopoietic growth factors such as G-CSF.
Undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such surgery.
Uncontrolled severe diarrhea
Uncontrolled active infection (fever ≥38 degrees due to infection)
S-1 oral drug administration difficulty due to difficulty swallowing, complete or incomplete digestive tract obstruction, gastrointestinal active bleeding, perforation;
severe hepatopathy including active hepatitis and hepatic cirrhosis, renal dysfunction, severe pulmonary diseases including interstitial pneumonia, pulmonary fibrosis and severe pulmonary emphysema, uncontrolled diabetes, hypertension and other chronic systematic diseases.
Chronic treatment with steroids.(In case of the patients with short-term use of steroids, the enrollment is permitted if the administration is stopped 2 weeks before screening.)
confirmed or suspected CNS metastasis
the history of peripheral nervous system impairment, obvious mental disorder or CNS impairment
clinically significant heart disease, including congestive heart failure, symptomatic coronal heart disease, arrythmia uncontrolled by medication and acute myocardial infarction or cardiac insufficiency within 6 months before screening
Drainage of pleural effusion, peritoneal effusion and pericardial effusion
pregnant women or women in lactation period
Fertile male or women of child-bearing potential refuse to take highly effective methods of birth control
Incidence of other second primary malignant tumors within 5 years, except for cured basal cell carcinoma and cervical carcinoma in situ.
patients of legal incapacity or who have the potential of influence the whole trial due to medical or ethic reasons.
Other patients who are not eligible to the trial under investigators' discretion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Shen, Prof.
Phone
+86 10 88196175
Email
lin100@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Li, Prof.
Phone
+86 10 88196561
Email
xiaotong10241@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Shen, Prof.
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Shen, Prof.
Phone
+86 10 88196175
Email
lin100@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Jie Li, Prof.
Phone
+86 10 88196561
Email
xiaotong10241@sina.com
12. IPD Sharing Statement
Learn more about this trial
SOX Sequential S-1 in Advanced Biliary Tract Carcinoma(BTC)and Pancreatic Cancer
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