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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by State Key Laboratory of Cancer Biology
Sponsor:
Collaborators:
Tianjin Union Medical Center
Beihua University
Chengdu Medical University
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Dake Chu, State Key Laboratory of Cancer Biology
ClinicalTrials.gov Identifier:
NCT01196260
First received: September 3, 2010
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: Capecitabine and Oxaliplatin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial on Combination Chemotherapy Treatments in Patients With Colorectal Cancer Stage II and III Among Chinese Population

Resource links provided by NLM:


Further study details as provided by State Key Laboratory of Cancer Biology:

Primary Outcome Measures:
  • To determine the objective response rate of patients with metastatic colorectal cancer received the combination of drugs [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
  • To determine the relapse of patients with metastatic colorectal cancer received the combination of drugs [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
  • To determine prognosis of patients with metastatic colorectal cancer received the combination of drugs [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the time to progression of metastatic colorectal cancer after treatment [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8000
Study Start Date: January 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196260

Contacts
Contact: Dake Chu, M.D. 86-29-84774516 chudake@hotmail.com

Locations
China, Shaanxi
State Key Laboratory of Cancer Biology Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Dake Chu, M.D.    86-29-84774516    chudake@hotmail.com   
Sponsors and Collaborators
State Key Laboratory of Cancer Biology
Tianjin Union Medical Center
Beihua University
Chengdu Medical University
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Dake Chu, M.D. Fourth Military Medical University
  More Information

Additional Information:
No publications provided

Responsible Party: Dake Chu, Dr., State Key Laboratory of Cancer Biology
ClinicalTrials.gov Identifier: NCT01196260     History of Changes
Other Study ID Numbers: Dake Chu-200401, StateKeyLab
Study First Received: September 3, 2010
Last Updated: October 10, 2014
Health Authority: China: Ministry of Health

Keywords provided by State Key Laboratory of Cancer Biology:
efficiency
capecitabine
oxaliplatin
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014