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Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00039611
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Clinical trial to study the effectiveness of combination chemotherapy in treating patients who have advanced colorectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Not Applicable

Detailed Description:


  • Provide oxaliplatin in combination with fluorouracil and leucovorin calcium using the FOLFOX4 regimen for front-line treatment in patients with no prior chemotherapy for advanced colorectal cancer who are not eligible for entry into ongoing clinical trials of higher priority. (The regimen in this Treatment Referral Center protocol is one that was found to be superior in a recent national intergroup study.)
  • Further determine the safety of this regimen in these patients.
  • Further determine the anti-tumor activity of this regimen, defined as the rate of time-to-treatment failure, time to progression, and survival, in these patients.
  • Capture data on subsequent salvage therapy administered to patients treated with this protocol.

OUTLINE: This is an open-label, multicenter study.

Patients receive oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on days 1 and 2, and fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients with clinical evidence of benefit from this treatment, defined as stable disease, partial response, or complete response as well as no increase in size of any measurable or evaluable lesion and no new sites of disease, may be eligible for additional courses.

Patients are followed until death.

PROJECTED ACCRUAL: A maximum of 300 patients per month will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oxaliplatin (NSC 266046) in Combination With 5-Fluorouracil and Leucovorin (FOLFOX4) for Patients Who Have Not Received Prior Chemotherapy for Advanced Colorectal Cancer
Study Start Date : May 2002
Actual Study Completion Date : October 2007

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Must not be eligible for Inter-group, Cooperative Group, or local clinical trials of higher priority
  • Histologically or cytologically confirmed colorectal adenocarcinoma

    • Locally advanced or metastatic
    • Not curable by surgery or amenable to radiation therapy with curative intent
  • Site of primary lesion must be or have been in the large bowel, as confirmed endoscopically, radiologically, or surgically
  • No separate histological or cytological confirmation of metastatic disease is required for patients with a history of colorectal cancer treated by surgical resection who develop radiological or clinical evidence of metastatic cancer unless:

    • More than 5 years has elapsed since prior primary surgery and the development of metastatic disease OR
    • Primary cancer was a Duke's A or B1 lesion
  • Measurable or evaluable disease
  • No prior chemotherapy for advanced colorectal cancer

    • Prior adjuvant therapy allowed for resected stage II, III, or IV disease with any regimen containing fluorouracil with or without irinotecan or with immunotherapy, provided recurrent disease has been documented



  • 15 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • Not specified


  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL (transfusion allowed)


  • Bilirubin no greater than 1.5 mg/dL (regardless of liver involvement secondary to tumor)
  • AST less than 5 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 5 times ULN


  • Creatinine no greater than 1.5 times ULN


  • No uncontrolled high blood pressure
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class III-IV cardiac disease


  • No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • No pleural effusion or ascites that causes respiratory compromise (i.e., dyspnea grade 2 or greater)


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions to compounds of similar chemical or biologic composition to platinum agents or oxaliplatin as well as other study agents
  • No neuropathy grade 2 or greater, regardless of causality
  • No HIV-positive patients receiving combination anti-retroviral therapy
  • No ongoing or active infection
  • No uncontrolled concurrent illness
  • No psychiatric or social situations that would preclude study compliance


Biologic therapy:

  • See Disease Characteristics
  • No concurrent sargramostim


  • See Disease Characteristics

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy)


  • See Disease Characteristics
  • At least 4 weeks since prior major surgery (e.g., laparotomy)
  • At least 2 weeks since prior minor surgery
  • Insertion of a vascular access device is not considered major or minor surgery


  • Recovered from effects of prior treatment
  • No other concurrent investigational agents
  • No oral cryotherapy on day 1 of each course

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00039611

Show Show 19 study locations
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: S. Percy Ivy, MD NCI - Investigational Drug Branch
Layout table for additonal information Identifier: NCT00039611    
Other Study ID Numbers: CDR0000069434
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: July 2002
Keywords provided by National Cancer Institute (NCI):
stage III colon cancer
stage IV colon cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Protective Agents
Vitamin B Complex