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A Phase I Study of Docetaxel Plus 5-FU, Cisplatin and Leucovorin in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study of Docetaxel Plus 5-FU, Cisplatin and Leucovorin in Patients With Advanced Solid Tumors


OBJECTIVES: I. Determine the maximum tolerated dose of docetaxel administered in combination
with cisplatin, fluorouracil, and leucovorin calcium in patients with advanced solid tumors.
II. Determine the toxicities associated with this combination regimen in this patient
population. III. Evaluate the clinical response to this combination regimen in these
patients.

OUTLINE: This is a dose escalation study of docetaxel and fluorouracil (5-FU). Patients
receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 2, and leucovorin
calcium IV immediately followed by 5-FU IV on days 1-5. Treatment repeats every 3 weeks in
the absence of disease progression. Cohorts of 3-5 patients receive escalating doses of
docetaxel and 5-FU until the maximum tolerated dose (MTD) is determined. The MTD is defined
as the dose preceding that at which more than 1 of 3 or 1 of 5 patients experience dose
limiting toxicity. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of advanced solid tumor No lymphomas Measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Neutrophil count at least 1,000/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AND SGOT no
greater than 2.5 times ULN AND Alkaline phosphatase no greater than ULN OR SGOT no greater
than ULN AND Alkaline phosphatase no greater than 5 times ULN Renal: Creatinine no greater
than 2.0 mg/dL Other: No pre-existing peripheral neuropathy greater than grade 2 Not
pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: No more than 2 prior treatments for metastatic disease Biologic
therapy: Not specified Chemotherapy: No prior high dose (pre transplant) chemotherapy
Prior paclitaxel allowed Endocrine therapy: Not specified Radiotherapy: No prior pelvic
radiotherapy Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Al B. Benson, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 98X2

NCT ID:

NCT00004913

Start Date:

January 2000

Completion Date:

May 2002

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611