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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 because the information has not been verified recently.
Verified April 2004 by Aronex Pharmaceuticals.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Aronex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00043199
First received: August 6, 2002
Last updated: June 23, 2005
Last verified: April 2004

August 6, 2002
June 23, 2005
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Complete list of historical versions of study NCT00043199 on ClinicalTrials.gov Archive Site
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A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Neoplasms
Drug: Aroplatin (Liposomal NDDP, L-NDDP)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00043199
C-726-01
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Aronex Pharmaceuticals
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Aronex Pharmaceuticals
April 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP