Phase II Trial of Trimetrexate (Neutrexin), 5-Fluorouracil and Leucovorin in Metastatic Colorectal Cancer


Phase 2
18 Years
74 Years
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

Phase II Trial of Trimetrexate (Neutrexin), 5-Fluorouracil and Leucovorin in Metastatic Colorectal Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Juan Eduardo Perez, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Grupo Oncologico Cooperativo del Sur

Authority:

United States: Federal Government

Study ID:

GOCS-12-CR-97

NCT ID:

NCT00003446

Start Date:

December 1997

Completion Date:

August 2005

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms

Name

Location