Combination Chemotherapy in Treating Patients With Metastatic or Unresectable Solid Tumors - Full Text View

Sponsors and Collaborators:	Albert Einstein College of Medicine of Yeshiva University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004242

Purpose

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

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: fluorouracil Drug: gemcitabine hydrochloride Drug: oxaliplatin	Phase I

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil Oxaliplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I Study of Oxaliplatin in Combination With 5-Fluorouracil and Gemcitabine in Patients With Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

October 1999

Detailed Description:

OBJECTIVES:

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.
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.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for the phase I dose escalation portion of this study. An additional 13 patients will be accrued for the recommended phase II dose portion of this study. Accrual will be completed within 14 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3

Hepatic:

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

Renal:

Creatinine normal OR
Creatinine clearance at least 60 mL/min

Cardiovascular:

No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia

Pulmonary:

No unexplained respiratory problems (e.g., nonproductive cough, dyspnea,
rales, pulmonary infiltrates, hypoxia, or tachypnea)

Other:

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)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and
platinum) and recovered
No more than 1 prior chemotherapy regimen for cancer

Endocrine therapy:

Not specified

Radiotherapy:

At least 4 weeks since prior radiotherapy

Surgery:

Not specified

Other:

No concurrent antiretroviral agents (HAART)
No other concurrent investigational agents or commercial therapies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004242

Locations

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

Albert Einstein College of Medicine of Yeshiva University

National Cancer Institute (NCI)

Investigators

Study Chair:

Howard S. Hochster, MD

New York University School of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000067487, AECM-1199904138, NCI-T99-0023, NYU-9944
Study First Received:	January 28, 2000
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00004242 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Antimetabolites
Oxaliplatin
Radiation-Sensitizing Agents
Immunologic Factors

Fluorouracil
Gemcitabine
Antiviral Agents
Immunosuppressive Agents

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Oxaliplatin
Radiation-Sensitizing Agents
Fluorouracil
Therapeutic Uses
Gemcitabine

ClinicalTrials.gov processed this record on May 07, 2009