Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Capecitabine and Oxaliplatin
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring efficiency, capecitabine, oxaliplatin, colorectal cancer
Eligibility Criteria
Inclusion Criteria:
- Patient must have a histologically proven TNM stage II or III adenocarcinoma of colon or rectum.
- Patient must received curative surgical with cancer free margin.
- Patients must have a performance status of 0,1, or 2.
- Patients must have an absolute neutrophil count of greater than or equal to 1500/ml, platelet count greater than or equal to 100,000/ml, and total serum bilirubin equal or less than the institution's upper limit or normal range.
- Patients must have fully recovered from any effects of surgery.
- Patients must provide a signed consent to participate in the study.
Age:
•18 and over
Performance status:
•WHO 0-2
Life expectancy:
•Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST/ALT no greater than 1.5 times ULN
Renal:
•Creatinine clearance greater than 30 mL/min
Cardiovascular:
More than 12 months since prior and no active clinically significant cardiovascular disease, including any of the following:
- Cerebrovascular accident
- Myocardial infarction
- Unstable angina
- New York Heart Association class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg)
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No active peptic ulcer or gastrointestinal bleeding within the past year
- No inflammatory bowel disease
- No other malignancy within the past 10 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
Exclusion Criteria:
- Patients with a proven history of peptic ulcer disease or gastroesophageal reflux.
- Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs.
- Patients who have received prior chemotherapy for colorectal cancer except for patients relapsing more than 6 months after completion of adjuvant chemotherapy.
- History of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease.
- Unresolved bacterial infection requiring treatment with antibiotics.
- Pregnant or lactating women may not participate in the study. Women/men of reproductive age group may not participate unless they have agreed to use an effective method of contraception.
- Patients who have allergy to any of the study drugs.
- Patients known to have HIV-1 virus infection because of the undetermined effect of this chemotherapy regimen in patients with HIV-1 and the potential for serious interaction with anti-HIV medications.
- Gilbert's disease.
- Lack of physical integrity of the upper gastrointestinal tract. Inability to swallow tablets or those who have malabsorption syndrome.
- Other serious concurrent infection
- Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.
Sites / Locations
- State Key Laboratory of Cancer BiologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
5-fluorouracil plus oxaliplatin
Arm Description
patients will be randomized assigned to receive 5-fluorouracil plus oxaliplatin
Outcomes
Primary Outcome Measures
To determine the objective response rate of patients with metastatic colorectal cancer received the combination of drugs
To determine the relapse of patients with metastatic colorectal cancer received the combination of drugs
To determine prognosis of patients with metastatic colorectal cancer received the combination of drugs
Secondary Outcome Measures
To evaluate the time to progression of metastatic colorectal cancer after treatment
Full Information
NCT ID
NCT01196260
First Posted
September 3, 2010
Last Updated
February 18, 2018
Sponsor
State Key Laboratory of Cancer Biology
Collaborators
Tianjin Union Medical Center, Beihua University, Chengdu Medical College, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01196260
Brief Title
Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III
Official Title
Clinical Trial on Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III Among Chinese Population
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State Key Laboratory of Cancer Biology
Collaborators
Tianjin Union Medical Center, Beihua University, Chengdu Medical College, Shanghai Jiao Tong University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will examine a new combination of drugs: Capecitabine and Oxaliplatin for the treatment of Stage II and III colorectal cancer. Capecitabine and Oxaliplatin are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination has a positive effect on metastatic colorectal cancer.
Detailed Description
This study will examine a new combination of drugs: Capecitabine and Oxaliplatinfor for the treatment of Stage II and III colorectal cancer. Capecitabine and Oxaliplatin are approved by the Food and Drug Administration (FDA) for use in colorectal cancer. The combination of drugs is experimental (not approved by the FDA as standard treatment), but is a widely used treatment option and preliminary studies have shown that treatment with the combination has a positive effect on metastatic colorectal cancer. In the present trial, we will study the combination of these two drugs in patients with colorectal cancer among Chinese population
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
efficiency, capecitabine, oxaliplatin, colorectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
5-fluorouracil plus oxaliplatin
Arm Type
Experimental
Arm Description
patients will be randomized assigned to receive 5-fluorouracil plus oxaliplatin
Intervention Type
Drug
Intervention Name(s)
Capecitabine and Oxaliplatin
Other Intervention Name(s)
1220099, CDK
Intervention Description
Capecitabine and Oxaliplatin will be under the NSCLC guideline
Primary Outcome Measure Information:
Title
To determine the objective response rate of patients with metastatic colorectal cancer received the combination of drugs
Time Frame
7 years
Title
To determine the relapse of patients with metastatic colorectal cancer received the combination of drugs
Time Frame
7 years
Title
To determine prognosis of patients with metastatic colorectal cancer received the combination of drugs
Time Frame
7 years
Secondary Outcome Measure Information:
Title
To evaluate the time to progression of metastatic colorectal cancer after treatment
Time Frame
7 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient must have a histologically proven TNM stage II or III adenocarcinoma of colon or rectum.
Patient must received curative surgical with cancer free margin.
Patients must have a performance status of 0,1, or 2.
Patients must have an absolute neutrophil count of greater than or equal to 1500/ml, platelet count greater than or equal to 100,000/ml, and total serum bilirubin equal or less than the institution's upper limit or normal range.
Patients must have fully recovered from any effects of surgery.
Patients must provide a signed consent to participate in the study.
Age:
•18 and over
Performance status:
•WHO 0-2
Life expectancy:
•Not specified
Hematopoietic:
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST/ALT no greater than 1.5 times ULN
Renal:
•Creatinine clearance greater than 30 mL/min
Cardiovascular:
More than 12 months since prior and no active clinically significant cardiovascular disease, including any of the following:
Cerebrovascular accident
Myocardial infarction
Unstable angina
New York Heart Association class II-IV congestive heart failure
Serious cardiac arrhythmia requiring medication
Uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg)
Other:
Not pregnant or nursing
Fertile patients must use effective contraception
No active peptic ulcer or gastrointestinal bleeding within the past year
No inflammatory bowel disease
No other malignancy within the past 10 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
Exclusion Criteria:
Patients with a proven history of peptic ulcer disease or gastroesophageal reflux.
Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs.
Patients who have received prior chemotherapy for colorectal cancer except for patients relapsing more than 6 months after completion of adjuvant chemotherapy.
History of other malignancy, except for cancers that have been treated with a curative intent and patient is without evidence of active disease.
Unresolved bacterial infection requiring treatment with antibiotics.
Pregnant or lactating women may not participate in the study. Women/men of reproductive age group may not participate unless they have agreed to use an effective method of contraception.
Patients who have allergy to any of the study drugs.
Patients known to have HIV-1 virus infection because of the undetermined effect of this chemotherapy regimen in patients with HIV-1 and the potential for serious interaction with anti-HIV medications.
Gilbert's disease.
Lack of physical integrity of the upper gastrointestinal tract. Inability to swallow tablets or those who have malabsorption syndrome.
Other serious concurrent infection
Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dake Chu, M.D.
Phone
86-29-84774516
Email
chudake@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dake Chu, M.D.
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Key Laboratory of Cancer Biology
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dake Chu, M.D.
Phone
86-29-84774516
Email
chudake@hotmail.com
12. IPD Sharing Statement
Links:
URL
http://www.fmmu.edu.cn
Description
Related Info
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Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III
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