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Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
This study has been completed.
Sponsored by: Grupo Oncologico Cooperativo del Sur
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003446
  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.

PURPOSE: Phase II trial to study the effectiveness of trimetrexate glucuronate, fluorouracil, and leucovorin in treating patients with recurrent or metastatic colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: fluorouracil
Drug: leucovorin calcium
Drug: trimetrexate glucuronate
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Fluorouracil Calcium gluconate Trimetrexate Trimetrexate glucuronate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Trial of Trimetrexate (Neutrexin), 5-Fluorouracil and Leucovorin in Metastatic Colorectal Cancer

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

Study Start Date: December 1997
Detailed Description:

OBJECTIVES: I. Evaluate tumor response and duration, one-year progression-free survival, and one-year overall survival in patients with recurrent or metastatic colorectal carcinoma when treated with trimetrexate glucuronate, fluorouracil, and leucovorin calcium.

OUTLINE: Patients receive trimetrexate glucuronate (TMTX) IV over 1 hour on day 1. Beginning 18 hours after the TMTX dosage, patients receive leucovorin calcium (CF) IV over 2 hours. Immediately after the completion of the CF infusion, patients receive an IV bolus injection of fluorouracil (5-FU). Beginning 4 hours after the 5-FU infusion, patients receive oral CF every 6 hours for 6 doses. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity or as long as the disease remains inoperable. Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 18-45 patients will be accrued for this study within 15 months.

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed colorectal carcinoma Inoperable advanced recurrent or metastatic disease Measurable disease outside previously irradiated area No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 to 74 Performance status: WHO 0-1 Life expectancy: More than 12 weeks Hematopoietic: WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.25 times upper limit of normal (ULN) SGOT less than 1.25 times ULN Albumin greater than 3.5 g/dL Renal: Creatinine clearance greater than 70 mL/min Cardiovascular: No history of congestive heart failure, myocardial infarction within the past 6 months, active ischemic heart disease, or uncontrolled hypertension Other: No weight loss more than 10% in the last 2 months No other prior malignancy except curatively treated carcinoma in situ of the cervix or non-melanoma skin cancer No history of alcohol abuse No uncontrolled medical or psychiatric disease Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent filgrastim (G-CSF) Chemotherapy: No prior chemotherapy for advanced disease Recovered from prior adjuvant therapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy for advanced disease Surgery: See Disease Characteristics Other: No other concurrent therapy

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003446

Locations
Argentina, Buenos Aires
Grupo Oncologico Cooperativo del Sur
Bahia Blanca, Buenos Aires, Argentina, 8000
Sponsors and Collaborators
Grupo Oncologico Cooperativo del Sur
Investigators
Study Chair: Juan Eduardo Perez, MD Grupo Oncologico Cooperativo del Sur
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000066475, GOCS-12-CR-97, NCI-V98-1457
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003446  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Clotrimazole
Rectal Neoplasms
Gastrointestinal Diseases
Miconazole
Colonic Diseases
Tioconazole
Leucovorin
Intestinal Diseases
Rectal Diseases
Recurrence
Intestinal Neoplasms
Rectal neoplasm
Folic Acid
Calcium, Dietary
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Rectal cancer
Trimetrexate
Colorectal Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Antifungal Agents
Therapeutic Uses
Vitamins
Micronutrients

ClinicalTrials.gov processed this record on January 14, 2009