NCT00005077

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating patients who have advanced cancer plus liver dysfunction.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

11 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

February 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2000

Completed
4 years until next milestone

First Posted

Study publicly available on registry

April 12, 2004

Completed
Last Updated

January 6, 2010

Status Verified

January 1, 2010

First QC Date

April 6, 2000

Last Update Submit

January 4, 2010

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

oxaliplatinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed metastatic or unresectable malignancy for which no curative or palliative treatment exists No brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: Platelet count at least 100,000/mm3 WBC at least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3 Hepatic: Abnormal liver function allowed Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No clinically significant neuropathy Not pregnant or nursing Fertile patients must use effective contraception No history of allergy to platinum compounds or antiemetics which may be used with study No uncontrolled concurrent illness (e.g., ongoing or active infection) PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors during first course of study Chemotherapy: No more than 3 prior regimens of chemotherapy At least 6 weeks since prior platinum chemotherapy At least 4 weeks since other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to more than 30% of bone marrow Surgery: At least 10 days since placement of biliary shunt Other: No other concurrent investigational agents No concurrent antiretroviral therapy (HAART) in HIV positive patients

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

Sponsors & Collaborators

Study Sites (11)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033-0800, United States

Location

Beckman Research Institute, City of Hope

Los Angeles, California, 91010, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

Oxaliplatin

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • James H. Doroshow, MD

    City of Hope Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 6, 2000

First Posted

April 12, 2004

Study Start

February 1, 2000

Last Updated

January 6, 2010

Record last verified: 2010-01

Locations

US(11)