Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

NCT00039611 | Completed

• 2 other identifiers: CDR0000069434CTEP-TRC-0201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 19

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.

Conditions

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

Interventions

FOLFOX regimen DRUG

fluorouracil DRUG

leucovorin calcium DRUG

oxaliplatin DRUG

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (19)

Anchorage Oncology Centre

Anchorage, Alaska, 99508, United States

Location

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259, United States

Location

University of California San Diego Cancer Center

La Jolla, California, 92093-0658, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Atlanta Cancer Care

Atlanta, Georgia, 30342, United States

Location

Cancer Center of Kansas - Wichita

Wichita, Kansas, 67214, United States

Location

Louisiana State University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Cancer Therapy Evaluation Program

Bethesda, Maryland, 20852, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

St. Vincent Hospital and Health Center

Billings, Montana, 59107-5200, United States

Location

Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Folfox protocol; Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• S. Percy Ivy, MD

  NCI - Investigational Drug Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2002
• Study Completion: October 1, 2007
• Last Updated: June 20, 2013

Record last verified: 2002-07

Locations

US (19)