Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004242
Recruitment Status : Completed
First Posted : December 11, 2003
Last Update Posted : February 11, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
Phase I trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or unresectable solid tumors. 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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: oxaliplatin Phase 1

Detailed Description:


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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Oxaliplatin in Combination With 5-Fluorouracil and Gemcitabine in Patients With Solid Tumors
Study Start Date : October 1999
Actual Primary Completion Date : December 2003

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm I
See detailed description.
Drug: fluorouracil
Drug: gemcitabine hydrochloride
Drug: oxaliplatin

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004242

United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Howard S. Hochster, MD New York University School of Medicine

Publications of Results:
Basu S, Goel S, Hochster H, et al.: Phase I and pharmacokinetic (PK) study of oxaliplatin (Ox) with gemcitabine (Gem) and continuous intravenous (CIV) infusion 5-fluorouracil (FU) in patients with advanced solid malignancies. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2132, 2002.

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00004242     History of Changes
Other Study ID Numbers: CDR0000067487
First Posted: December 11, 2003    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: July 2002

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs