Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00039611
• Other study ID #: CDR0000069434
• Secondary ID: CTEP-TRC-0201
• Status: Completed
• Phase: N/A
• First received: June 6, 2002
• Last updated: June 18, 2013
• Start date: May 2002
• Est. completion date: October 2007

Study information

• Verified date: July 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• FOLFOX regimen

• fluorouracil

• leucovorin calcium

• oxaliplatin

Locations

Country	Name	City	State
United States	Anchorage Oncology Centre	Anchorage	Alaska
United States	Atlanta Cancer Care	Atlanta	Georgia
United States	Cancer Therapy Evaluation Program	Bethesda	Maryland
United States	St. Vincent Hospital and Health Center	Billings	Montana
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Ireland Cancer Center	Cleveland	Ohio
United States	Mayo Clinic	Jacksonville	Florida
United States	University of California San Diego Cancer Center	La Jolla	California
United States	Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut
United States	Louisiana State University School of Medicine	New Orleans	Louisiana
United States	NYU School of Medicine's Kaplan Comprehensive Cancer Center	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Cancer Center of Kansas - Wichita	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,