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A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2004 by Aronex Pharmaceuticals.
Recruitment status was:  Active, not recruiting
Information provided by:
Aronex Pharmaceuticals Identifier:
First received: August 6, 2002
Last updated: June 23, 2005
Last verified: April 2004
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.

Condition Intervention Phase
Colorectal Neoplasms Drug: Aroplatin (Liposomal NDDP, L-NDDP) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Aronex Pharmaceuticals:

Estimated Enrollment: 40
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00043199

United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
University Medical Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
Aronex Pharmaceuticals
  More Information Identifier: NCT00043199     History of Changes
Other Study ID Numbers: C-726-01
Study First Received: August 6, 2002
Last Updated: June 23, 2005

Keywords provided by Aronex Pharmaceuticals:
Colorectal Neoplasms
Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumor
Neoplasms, Colorectal

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents processed this record on September 19, 2017