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Phase I Study of Oxaliplatin in Combination With 5-Fluorouracil and Gemcitabine in Patients With Solid Tumors

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of Oxaliplatin in Combination With 5-Fluorouracil and Gemcitabine in Patients With Solid Tumors


I. Determine the maximum tolerated dose, recommended phase II dose, and associated toxic
effects of the triple combination of continuous infusion fluorouracil, weekly gemcitabine,
and oxaliplatin in patients with metastatic or unresectable solid tumors.

II. Define sequence dependent toxic effects, if any, and establish pharmacokinetic and
pharmacodynamic relationships in context of this triple combination chemotherapy in this
patient population.

OUTLINE: This is a dose-escalation study of oxaliplatin and gemcitabine.

For course 1, and then course 3 and beyond, patients receive oxaliplatin IV over 2 hours on
day 1, followed by gemcitabine IV over 30 minutes on days 1 and 8, and then fluorouracil IV
continuously on days 1-14. For course 2, patients receive treatment in the same manner as in
course 1, except gemcitabine is given initially, followed by oxaliplatin, and then
fluorouracil. Treatment continues every 21 days in the absence of unacceptable toxicity or
disease progression.

Cohorts of 1-6 patients receive escalating doses of oxaliplatin and gemcitabine until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 6 patients experience dose-limiting toxicity. The recommended phase II dose
(RPTD) is defined as the dose preceding MTD.

Once RPTD is defined, the cohort is expanded to an additional 13 patients. These patients
receive a fixed dose of oxaliplatin, gemcitabine, and fluorouracil as determined by the
phase I dose escalation portion of this study.

Patients are followed for disease progression.

Inclusion Criteria


- Histologically or clinically confirmed metastatic or unresectable solid tumor for
which no standard curative or palliative therapy exists or is no longer

- No known brain metastases



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm3

- Platelet count at least 100,000/mm3


- Bilirubin normal

- Proven Gilbert's syndrome (UGT1A1 promoter mutation or clinical

- documentation of stress bilirubin levels) allowed

- AST/ALT no greater than 3 times upper limit of normal


- Creatinine normal OR

- Creatinine clearance at least 60 mL/min


- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia


- No unexplained respiratory problems (e.g., nonproductive cough, dyspnea,

- rales, pulmonary infiltrates, hypoxia, or tachypnea)


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No clinical evidence of neuropathy

- No prior allergy to platinum compounds

- No prior allergy to antiemetics appropriate for administration in

- conjunction with protocol directed chemotherapy

- No other concurrent uncontrolled illness (e.g., active infection)



- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and

- platinum) and recovered

- No more than 1 prior chemotherapy regimen for cancer


- At least 4 weeks since prior radiotherapy


- No concurrent antiretroviral agents (HAART)

- No other concurrent investigational agents or commercial therapies

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Howard S. Hochster, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine


United States: Federal Government

Study ID:




Start Date:

October 1999

Completion Date:

Related Keywords:

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



Albert Einstein Comprehensive Cancer Center Bronx, New York  10461
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016