Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003446
• Other study ID #: GOCS-12-CR-97
• Secondary ID: CDR0000066475NCI
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 25, 2013
• Start date: December 1997
• Est. completion date: August 2005

Study information

• Verified date: September 2001
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• fluorouracil

• leucovorin calcium

• trimetrexate glucuronate

Locations

Country	Name	City	State
Argentina	Grupo Oncologico Cooperativo del Sur	Bahia Blanca	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Oncologico Cooperativo del Sur

Country where clinical trial is conducted

Argentina,