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

NCT01196260 | Unknown Phase 2 DMC

• 2 other identifiers: Dake Chu-200401StateKeyLab
• Study Type: interventional
• Target: 8,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

efficiency; capecitabine; oxaliplatin; colorectal cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• To evaluate the time to progression of metastatic colorectal cancer after treatment

  7 years

Study Arms (1)

5-fluorouracil plus oxaliplatin

EXPERIMENTAL

patients will be randomized assigned to receive 5-fluorouracil plus oxaliplatin

Drug: Capecitabine and Oxaliplatin

Interventions

Capecitabine and Oxaliplatin DRUG

Capecitabine and Oxaliplatin will be under the NSCLC guideline

Also known as: 1220099, CDK

5-fluorouracil plus oxaliplatin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

State Key Laboratory of Cancer Biology

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Dake Chu, M.D.

  Air Force Military Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dake Chu, M.D.

CONTACT

86-29-84774516; chudake@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 8, 2010
• Study Start: January 1, 2004
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 20, 2018

Record last verified: 2018-02

Locations

CN (1)