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Related Studies
Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
This study has been completed.
First Received: June 6, 2002   Last Updated: January 10, 2009   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00039611
  Purpose

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 Intervention
Colorectal Cancer
Drug: FOLFOX regimen
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Fluorouracil Leucovorin Citrovorum factor Oxaliplatin Leucovorin Calcium Folinic acid calcium salt pentahydrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2002
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 15 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • 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)

Hepatic:

  • 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

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • 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

Pulmonary:

  • 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)

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No concurrent sargramostim

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

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

Surgery:

  • 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

Other:

  • Recovered from effects of prior treatment
  • No other concurrent investigational agents
  • No oral cryotherapy on day 1 of each course
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00039611

  Show 19 Study Locations
Sponsors and Collaborators
Investigators
Study Chair: S. Percy Ivy, MD NCI - Investigational Drug Branch
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069434, CTEP-TRC-0201
Study First Received: June 6, 2002
Last Updated: January 10, 2009
ClinicalTrials.gov Identifier: NCT00039611     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Antimetabolites
Vitamin B Complex
Digestive System Neoplasms
Immunologic Factors
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Rectal Neoplasm
Leucovorin
Trace Elements
Intestinal Diseases
Immunosuppressive Agents
Rectal Diseases
Recurrence
Intestinal Neoplasms
Calcium, Dietary
Oxaliplatin
Digestive System Diseases
Rectal Cancer
Vitamins
Fluorouracil
Gastrointestinal Neoplasms
Micronutrients
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Physiological Effects of Drugs
Leucovorin
Rectal Diseases
Oxaliplatin
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients
Digestive System Neoplasms
Vitamin B Complex
Growth Substances
Intestinal Diseases
Immunosuppressive Agents
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009