Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00004102
First received: December 10, 1999
Last updated: March 25, 2011
Last verified: March 2011
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Leucovorin may increase the effectiveness of fluorouracil by making tumor cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of oxaliplatin, fluorouracil, and leucovorin in treating patients who have colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: FOLFOX regimen
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of Eloxatin in Combination With 5-Fluorouracil and Leucovorin in Patients With Advanced Colorectal Carcinoma

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Study Start Date: January 1999
Primary Completion Date: November 2001 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Evaluate the quantitative and qualitative toxicities of oxaliplatin combined with fluorouracil and leucovorin calcium in patients with advanced adenocarcinoma of the colon or rectum.

OUTLINE: Patients receive leucovorin calcium IV over 10-20 minutes followed within 10 minutes by fluorouracil IV bolus on days 1, 8, 15, 29, 36, and 43. Patients receive oxaliplatin IV over 2 hours prior to leucovorin calcium and fluorouracil on days 1, 15, 29, and 43. Treatment repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses upon approval by the sponsor. Patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven advanced adenocarcinoma of the colon or rectum No prior systemic chemotherapy OR Adjuvant chemotherapy only, completed 6 months prior to study and with subsequent development of recurrent disease At least 1 bidimensionally measurable lesion No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL (no greater than 5.0 mg/dL if due to intrahepatic biliary obstruction not amenable to biliary decompression, if approved by the protocol investigator) SGOT no greater than 4 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No myocardial infarction within the past 6 months No congestive heart failure Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No neurologic disease No active or uncontrolled infection No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix No medical or psychiatric disorders that would prevent compliance

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for malignant disease Surgery: Recovered from any prior surgery Other: At least 30 days since other prior investigational agent No other concurrent investigational agents No concurrent anticancer agents

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004102

Locations
United States, New York
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Study Chair: Howard S. Hochster, MD New York University School of Medicine
  More Information

Additional Information:
Publications:
Hochster HS, Chachoua A, Speyer J, et al.: First-line activity of oxaliplatin with weekly bolus 5FU and low-dose leucovorin (LV) in advanced colorectal cancer (CRC). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-548, 2001.

ClinicalTrials.gov Identifier: NCT00004102     History of Changes
Other Study ID Numbers: CDR0000067321, P30CA016087, NYU-9863, SANOFI-EFC7132, NCI-G99-1593
Study First Received: December 10, 1999
Last Updated: March 25, 2011
Health Authority: United States: Federal Government

Keywords provided by New York University School of Medicine:
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum

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

ClinicalTrials.gov processed this record on April 21, 2014