NCT00057395

Brief Summary

To determine the rate of response and the duration of the response following therapy with Aroplatinin patients with advanced solid malignancies.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2003

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 2004

First QC Date

April 1, 2003

Last Update Submit

June 23, 2005

Conditions

Esophageal NeoplasmsHepatocellular CarcinomaColorectal NeoplasmsOvarian NeoplasmsPancreatic NeoplasmsNeoplasms

Keywords

Esophageal NeoplasmsEsophagus NeoplasmEsophagus CancerEsophageal CancerEsophageal TumorsEsophagus TumorsNeoplasms, EsophagealHepatocellular CarcinomaCarcinoma, HepatocellularHepatomaColorectal NeoplasmsColorectal CancerColorectal CarcinomaColorectal TumorNeoplasms, ColorectalOvarian NeoplasmsOvary NeoplasmsOvary CancerOvary CarcinomaOvarian CancerOvarian CarcinomaNeoplasms, OvarianPancreatic NeoplasmsPancreatic CancerPancreas NeoplasmsPancreas CancerNeoplasms, PancreaticNeoplasms, Pancreasand other solid tumors

Interventions

Aroplatin (Liposomal NDDP, L-NDDP)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced solid malignancies;
  • Amenable to therapy with DACH platinum agents;
  • Measurable disease (RECIST criteria);
  • ECOG performance score of 0-2;
  • Adequate hematopoietic, liver and renal function;
  • Adequate cardiac function (maximum of class II, NYHA);
  • Women of childbearing potential must have a negative urine or serum pregnancy test;
  • Signed written informed consent;
  • Subjects must be willing to be followed during the course of treatment/observation and follow-up.

You may not qualify if:

  • No other active malignancies;
  • No prior therapy with oxaliplatin;
  • No known brain metastases;
  • Active, uncontrolled infection or other serious medical illnesses;
  • Not using or have used any investigational therapy during four weeks before start of protocol treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Esophageal NeoplasmsCarcinoma, HepatocellularColorectal NeoplasmsOvarian NeoplasmsPancreatic NeoplasmsNeoplasms

Interventions

bis-neodecanoato-1,2-diaminocyclohexaneplatinum(II)

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsLiver DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersPancreatic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 1, 2003

First Posted

April 2, 2003

Last Updated

June 24, 2005

Record last verified: 2004-04

Locations

US(1)