NCT00043199

Brief Summary

To determine the rate of response and duration of reponse following therapy with Aroplatin in subjects with advanced colorectal cancer resistant to standard therapies. Secondary objectives are to determine safety and tolerability of the Aroplatin therapy.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

2 active sites

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

August 6, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2002

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 2004

First QC Date

August 6, 2002

Last Update Submit

June 23, 2005

Conditions

Colorectal Neoplasms

Keywords

Colorectal NeoplasmsColorectal CancerColorectal CarcinomaColorectal TumorNeoplasms, ColorectalUnresectableMetastaticRefractory

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:

  • Colorectal cancer, locally recurrent, unresectable or metastatic disease (AJCC);
  • Measurable disease (RECIST criteria);
  • Cancer refractory to 5-FU/leucovorin or capecitabine, and irinotecan;
  • ECOG performance score of 0-2;
  • Adequate hematopoietic, liver and renal function;
  • Adequate cardiac function (maximum of class II, NYHA);
  • Women of child-bearing potential must have a negative urine or serum pregnancy test;
  • Signed written informed consent;
  • Subjects must be willing to to be followed during the course of treatment/observation and follow-up.

You may not qualify if:

  • Other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer;
  • Pregnant or breast feeding subjects, or male or female subjects of child producing potential who will not agree to use adequate contraception during the treatment phase of the study;
  • Prior therapy with oxaliplatin;
  • Known brain metastases;
  • Active, uncontrolled infection or other serious medical illnesses;
  • Subjects may not be using or have used any investigational therapy during four weeks before start of the protocol treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

University Medical Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm Metastasis

Interventions

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

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 6, 2002

First Posted

August 8, 2002

Last Updated

June 24, 2005

Record last verified: 2004-04

Locations

US(2)