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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by State Key Laboratory of Cancer Biology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
State Key Laboratory of Cancer Biology
ClinicalTrials.gov Identifier:
NCT01196260
First received: September 3, 2010
Last updated: September 7, 2010
Last verified: September 2010
  Purpose

This study will examine a new combination of drugs: 5-fluorouracil and capecitabine for the treatment of Stage II and III colorectal cancer. 5-fluorouracil and capecitabine 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: 5-fluorouracil and Capecitabine
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: 1000
Study Start Date: January 2004
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 5-fluorouracil plus oxaliplatin
patients will be randomized assigned to receive 5-fluorouracil plus oxaliplatin
Drug: 5-fluorouracil and Capecitabine
5-fluorouracil and Capecitabine will be under the NSCLC guideline
Other Names:
  • 1220099
  • CDK

Detailed Description:

This study will examine a new combination of drugs: 5-fluorouracil and capecitabine for the treatment of Stage II and III colorectal cancer. 5-fluorouracil and capecitabine 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:   Yes
Criteria

Inclusion Criteria:

  • Patient must have a histologically proven adenocarcinoma of colon or rectum with metastases or local recurrence.
  • Patients must have at least one measurable lesion according to the RECIST criteria. Bone metastases, ascites and pleural effusion are not measurable.
  • Minimum indicator lesion size as follows:

    • Greater than or equal to 20 mm measured by conventional CT Greater than or equal to 10 mm measured by spiral techniques
  • Prior use of celecoxib for the treatment of nonmalignant disorders is allowed.
  • Patients must have a performance status of 0,1, or 2 by the Southwest Oncology Group criteria.
  • Patients must have a calculated creatinine clearance of greater than 50 ml/min.
  • 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 recovered from any effects of surgery.
  • Evaluable disease must be present outside radiation field. At least 3 weeks must have elapsed after discontinuation of radiation therapy.
  • Patients must provide a signed consent to participate in the study.

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 (including capecitabine or irinotecan) 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 or sulfa 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
Investigators
Principal Investigator: Qingchuan Zhao, M.D. Fourth Military Medical University
  More Information

Additional Information:
No publications provided

Responsible Party: Dake Chu Dr., Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01196260     History of Changes
Other Study ID Numbers: CDK-122099, StateKeyLab
Study First Received: September 3, 2010
Last Updated: September 7, 2010
Health Authority: China: Ministry of Health

Keywords provided by State Key Laboratory of Cancer Biology:
efficiency
5-fluorouracil
Capecitabine
colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Capecitabine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014