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Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) for Colorectal Cancer in China (SCI-101)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
S-1, leucovorin, oxaliplatin
Sponsored by
Shen Lin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring S-1, leucovorin, oxaliplatin, colorectal cancer, SOL, unresectable or recurrent colorectal cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Advanced unresectable or recurrent colorectal cancer patients which meet the following criteria:

    • Willing to sign ICF
    • Could orally take investigational product
    • Pathology diagnosis is adenocarcinoma
    • Above 20 years
    • No previous treatment(including: radiotherapy,chemotherapy and immunotherapy)
    • For recurrent cases, if the patient had received adjuvant chemotherapy that didn't include S-1 and L-OHP in 180 days ago, he/she could be enrolled in
    • With target lesions with diameter which is longer than 1cm in spiral CT or MRI examination within 30 days

  • Lab test within 15 days meet following criteria

    • Hemoglobin higher than 9.0g/dL
    • Leukocyte higher than 12,000/mm3
    • Neutrophil higher than 2,000/mm3
    • PLT higher than 10.0 104/mm3
    • Bilirubin lower than 1.5 times of upper limit of normal range
    • AST,ALT,ALP lower than 2.5 times of upper limit of normal range
    • Creatinine lower than upper limit of normal range

When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range

  • ECOG 0 or 1
  • Expected survival time more than 90 days

Exclusion Criteria:

  • The patient who meet the following criteria should be excluded from this trial
  • Patients who have severe drug allergic history(including: platinum related drugs,5-FU,FT,LV,5-HT3 receptor antagonist)
  • Attended other clinical trial within 4 weeks
  • Received transfusion of blood,related products or G-CSF within 15 days
  • Received surgery within 4 weeks and the effect hadn't vanished
  • Have diarrhea
  • Have complication of active infection(infection caused fever higher than 38℃)
  • Have complication of poor controlled hypercalcemia,hypertension,diabetes
  • Have complication of severe ECG abnormal or other heart disease which will affect clinical treatment(including: cardiac dysfunction,myocardial infarction,angina)
  • Have complication of severe pulmonary disease(including:interstitial pneumonia,pulmonary fibrosis,severe emphysema)
  • Have complication of psychiatric disorder which will affect clinical treatment or have history of CNS disease
  • Have complication of active gastrointestinal bleeding
  • Have pleural effusion,ascites or pericardial effusion that need drainage
  • Have complication of multiple bone metastasis
  • Have severe complication(including:ileus,renal insufficiency,hepatic insufficiency,cerebrovascular disturbance)
  • Have brain metastasis or suspicious brain metastasis
  • Have active multiple primary cancer
  • Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures
  • Investigator judge not eligible to this trial

Sites / Locations

  • Beijing Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOL

Arm Description

single arm

Outcomes

Primary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Secondary Outcome Measures

Tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, and follow up till disease progression or withdrawal from study due to intolerable adverse events (AE)

Full Information

First Posted
April 21, 2010
Last Updated
May 17, 2015
Sponsor
Shen Lin
Collaborators
307 Hospital of PLA, Beijing Union Hosptial, Tianjin Medical University Cancer Institute and Hospital, Hebei Provincial Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01110941
Brief Title
Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) for Colorectal Cancer in China
Acronym
SCI-101
Official Title
A Multicenter Feasibility Study With S-1, Oxaliplatin and Oral Leucovorin (SOL) for the Patients With Untreated Metastatic Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shen Lin
Collaborators
307 Hospital of PLA, Beijing Union Hosptial, Tianjin Medical University Cancer Institute and Hospital, Hebei Provincial Cancer Hospital

4. Oversight

5. Study Description

Brief Summary
S-1 is an oral fluoropyrimidine with demonstrated efficacy on gastric cancer and colorectal cancer. The new regimen with Oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on colorectal cancer. This study is to explore the feasibility of the SOL regimen on efficacy and tolerability on Chinese colorectal cancer patients.
Detailed Description
Endpoints: Primary endpoints: adverse drug reaction Secondary endpoints: Overall Response Rate：ORR Progress Free Survival: PFS Time to Treatment Failure：TTF

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
S-1, leucovorin, oxaliplatin, colorectal cancer, SOL, unresectable or recurrent colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOL
Arm Type
Experimental
Arm Description
single arm
Intervention Type
Drug
Intervention Name(s)
S-1, leucovorin, oxaliplatin
Other Intervention Name(s)
S-1(20mg、25mg)--Taiho Pharmaceutical Co., Ltd.；, LV (25 mg)；, L-OHP (50 mg)--Sanofi Aventis Co., Ltd.
Intervention Description
S-1(20mg、25mg), capsule, 40~60mg, Bid,p.o., day1~7； LV (25 mg), tablet, 25mg,Bid,p.o., day1~7； L-OHP (50 mg),injection 85mg/m2, day1. repeated at every 2 weeks cycle till disease progression.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
from first administration till 28 days after last dosage
Secondary Outcome Measure Information:
Title
Tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, and follow up till disease progression or withdrawal from study due to intolerable adverse events (AE)
Time Frame
every 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Advanced unresectable or recurrent colorectal cancer patients which meet the following criteria: Willing to sign ICF Could orally take investigational product Pathology diagnosis is adenocarcinoma Above 20 years No previous treatment(including: radiotherapy,chemotherapy and immunotherapy) For recurrent cases, if the patient had received adjuvant chemotherapy that didn't include S-1 and L-OHP in 180 days ago, he/she could be enrolled in With target lesions with diameter which is longer than 1cm in spiral CT or MRI examination within 30 days Lab test within 15 days meet following criteria Hemoglobin higher than 9.0g/dL Leukocyte higher than 12,000/mm3 Neutrophil higher than 2,000/mm3 PLT higher than 10.0 104/mm3 Bilirubin lower than 1.5 times of upper limit of normal range AST,ALT,ALP lower than 2.5 times of upper limit of normal range Creatinine lower than upper limit of normal range When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range ECOG 0 or 1 Expected survival time more than 90 days Exclusion Criteria: The patient who meet the following criteria should be excluded from this trial Patients who have severe drug allergic history(including: platinum related drugs,5-FU,FT,LV,5-HT3 receptor antagonist) Attended other clinical trial within 4 weeks Received transfusion of blood,related products or G-CSF within 15 days Received surgery within 4 weeks and the effect hadn't vanished Have diarrhea Have complication of active infection(infection caused fever higher than 38℃) Have complication of poor controlled hypercalcemia,hypertension,diabetes Have complication of severe ECG abnormal or other heart disease which will affect clinical treatment(including: cardiac dysfunction,myocardial infarction,angina) Have complication of severe pulmonary disease(including:interstitial pneumonia,pulmonary fibrosis,severe emphysema) Have complication of psychiatric disorder which will affect clinical treatment or have history of CNS disease Have complication of active gastrointestinal bleeding Have pleural effusion,ascites or pericardial effusion that need drainage Have complication of multiple bone metastasis Have severe complication(including:ileus,renal insufficiency,hepatic insufficiency,cerebrovascular disturbance) Have brain metastasis or suspicious brain metastasis Have active multiple primary cancer Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures Investigator judge not eligible to this trial
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100036
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26158159
Citation
Lu M, Wang Y, Liu W, Bai C, Xu J, Shen L. A Multicenter Feasibility Study with S-1, Oxaliplatin and Oral Leucovorin (SOL) for the Patients with Untreated Metastatic Colorectal Cancer: The Result of Final Analysis. Hepatogastroenterology. 2014 Jun;61(132):1018-23.
Results Reference
derived

Learn more about this trial

Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) for Colorectal Cancer in China

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