Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III

Clinical Trial on Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III Among Chinese Population

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Capecitabine and Oxaliplatin

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

• Study Type: Interventional
• Enrollment (Anticipated): 8000
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • State Key Laboratory of Cancer Biology
      • Contact: Dake Chu, M.D.; Phone Number: 86-29-84774516; Email: chudake@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 5-fluorouracil plus oxaliplatin; patients will be randomized assigned to receive 5-fluorouracil plus oxaliplatin	Drug: Capecitabine and Oxaliplatin; Capecitabine and Oxaliplatin will be under the NSCLC guideline; Other Names: 1220099; CDK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the objective response rate of patients with metastatic colorectal cancer received the combination of drugs	7 years
To determine the relapse of patients with metastatic colorectal cancer received the combination of drugs	7 years
To determine prognosis of patients with metastatic colorectal cancer received the combination of drugs	7 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the time to progression of metastatic colorectal cancer after treatment	7 years

Collaborators and Investigators

• Sponsor: State Key Laboratory of Cancer Biology
• Collaborators: Shanghai Jiao Tong University School of Medicine; Tianjin Union Medical Center; Beihua University; Chengdu Medical College

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: September 3, 2010
• First Submitted That Met QC Criteria: September 7, 2010
• First Posted (ESTIMATE): September 8, 2010

Study Record Updates

• Last Update Posted (ACTUAL): February 20, 2018
• Last Update Submitted That Met QC Criteria: February 18, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: colorectal cancer; capecitabine; oxaliplatin; efficiency
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Capecitabine; Oxaliplatin
• Other Study ID Numbers: Dake Chu-200401; StateKeyLab (REGISTRY: StateKeyLab)