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Oxaliplatin (NSC 266046) in Combination With 5-Fluorouracil and Leucovorin (FOLFOX4) for Patients Who Have Not Received Prior Chemotherapy for Advanced Colorectal Cancer

15 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

Oxaliplatin (NSC 266046) in Combination With 5-Fluorouracil and Leucovorin (FOLFOX4) for Patients Who Have Not Received Prior Chemotherapy for Advanced Colorectal Cancer


- 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

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.

Inclusion Criteria


- 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

- 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

- 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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

S. Percy Ivy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Investigational Drug Branch


United States: Federal Government

Study ID:




Start Date:

May 2002

Completion Date:

October 2007

Related Keywords:

  • Colorectal Cancer
  • stage III colon cancer
  • stage IV colon cancer
  • stage III rectal cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms



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