NCT00004242

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2000

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2003

Completed
Last Updated

February 11, 2013

Status Verified

July 1, 2002

Enrollment Period

4.2 years

First QC Date

January 28, 2000

Last Update Submit

February 8, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Arms (1)

Arm I

EXPERIMENTAL

See detailed description.

Drug: fluorouracilDrug: gemcitabine hydrochlorideDrug: oxaliplatin

Interventions

fluorouracilDRUG
Arm I
gemcitabine hydrochlorideDRUG
Arm I
oxaliplatinDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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: 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 Radiotherapy: * At least 4 weeks since prior radiotherapy Other: * No concurrent antiretroviral agents (HAART) * No other concurrent investigational agents or commercial therapies

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Interventions

FluorouracilGemcitabineOxaliplatin

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesCoordination ComplexesOrganic Chemicals

Study Officials

  • Howard S. Hochster, MD

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2000

First Posted

December 11, 2003

Study Start

October 1, 1999

Primary Completion

December 1, 2003

Last Updated

February 11, 2013

Record last verified: 2002-07

Locations

US(2)