- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00043199
A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies
June 23, 2005 updated by: Aronex Pharmaceuticals
A Phase II Study of Aroplatin in Subjects With Recurrent, Unresectable and Metastatic Colorectal Cancer Refractory to 5-Fluorouracil (5-FU)/Leucovorin or Capecitabine, and Irinotecan
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Primary Objective:
- To determine response rate (RR; complete and partial response[CR,PR] and duration after therapy with Aroplatin (Liposomal NDDP, L-NDDP) in subjects with locally recurrent, unresectable or metastatic colorectal cancer refractory to 5-FU/leucovorin or capecitabine, and irinotecan.
Secondary Objective:
- To determine safety and tolerability of the Aroplatin therapy.
This is a single-arm, open-label phase II study. Subjects refractory to 5-FU/leucovorin or capecitabine, and irinotecan therapies will be enrolled. Dosing will be every four weeks with individual dose escalations and adjustments for toxicity.
Study Type
Interventional
Enrollment
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724
- Arizona Cancer Center
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Tucson, Arizona, United States, 85724
- University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
August 6, 2002
First Submitted That Met QC Criteria
August 7, 2002
First Posted (Estimate)
August 8, 2002
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
April 1, 2004
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplasms
- Colorectal Neoplasms
- Antineoplastic Agents
- bis-neodecanoato-1,2-diaminocyclohexaneplatinum(II)
Other Study ID Numbers
- C-726-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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