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Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FOLFOX regimen
fluorouracil
leucovorin calcium
oxaliplatin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anchorage Oncology Centre
  • Mayo Clinic Scottsdale
  • University of California San Diego Cancer Center
  • Yale Comprehensive Cancer Center
  • Mayo Clinic
  • Atlanta Cancer Care
  • Cancer Center of Kansas - Wichita
  • Louisiana State University School of Medicine
  • Cancer Therapy Evaluation Program
  • Mayo Clinic Cancer Center
  • St. Vincent Hospital and Health Center
  • Southern Nevada Cancer Research Foundation
  • Cancer Institute of New Jersey
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
  • Lineberger Comprehensive Cancer Center, UNC
  • Ireland Cancer Center
  • Fox Chase Cancer Center
  • Huntsman Cancer Institute
  • Virginia Mason Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2002
Last Updated
June 18, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00039611
Brief Title
Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
July 2002
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
FOLFOX regimen
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Drug
Intervention Name(s)
oxaliplatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S. Percy Ivy, MD
Organizational Affiliation
NCI - Investigational Drug Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Anchorage Oncology Centre
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of California San Diego Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
Yale Comprehensive Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Atlanta Cancer Care
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Cancer Center of Kansas - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Louisiana State University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Cancer Therapy Evaluation Program
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Vincent Hospital and Health Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-5200
Country
United States
Facility Name
Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

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Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

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