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PHASE I TRIAL OF SEQUENTIAL TOMUDEX AND 5-FLUOROURACIL IN SUBJECTS WITH ADVANCED COLORECTAL CARCINOMA


Phase 1
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

PHASE I TRIAL OF SEQUENTIAL TOMUDEX AND 5-FLUOROURACIL IN SUBJECTS WITH ADVANCED COLORECTAL CARCINOMA


OBJECTIVES: I. Determine the maximum tolerated dose of raltitrexed when administered with
fluorouracil in patients with advanced colorectal carcinoma. II. Determine the toxicity and
safety of this regimen in these patients. III. Assess, in a preliminary manner, the
antitumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of raltitrexed. Patients receive raltitrexed IV
over 15 minutes followed 24 hours later by fluorouracil IV. Treatment continues every 3
weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
patients receive escalating doses of raltitrexed until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose immediately preceding that at which 2 of 6
patients experience dose-limiting toxicity. An additional 6-10 patients are treated at the
MTD. Patients are followed for 6 weeks.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-20
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven metastatic, locally recurrent, or
surgically unresectable colorectal carcinoma Measurable disease No CNS metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5
times normal (5 times normal if known liver metastases) Renal: Creatinine no greater than
1.5 mg/dL Other: No severe concurrent infection Not pregnant or nursing Negative pregnancy
test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1
prior chemotherapy regimen Prior fluorouracil-based regimen for advanced colorectal cancer
allowed Prior fluorouracil with radiotherapy not considered therapy for advanced disease
At least 4 weeks since prior chemotherapy (8 weeks for mitomycin or nitrosoureas) and
recovered Endocrine therapy: No concurrent steroids except for antiemesis or as
replacement therapy Radiotherapy: See Chemotherapy No prior radiotherapy to more than 30%
of bone marrow Surgery: See Disease Characteristics At least 4 weeks since prior surgery
unless fully recovered Other: No concurrent vitamin supplements containing folic acid No
other concurrent anticancer therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Gary K. Schwartz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

95-021

NCT ID:

NCT00002828

Start Date:

April 1995

Completion Date:

November 2001

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021