Aroplatin and Capecitabine in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies

June 23, 2005 updated by: Aronex Pharmaceuticals

A Phase I/II Study of Aroplatin and Capecitabine in Subjects With Unresectable Local Recurrence or Distant Metastases of Colorectal Cancer Refractory to 5-FU/Leucovorin and Irinotecan

This study is a Phase I/II study. In Phase I of this study, the objective is to determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and capecitabine in subjects with unresectable, local recurrence or distant metastases of colorectal cancer refractory to 5-FU/leucovorin and irinotecan. In Phase II, the primary objective is to evaluate the response proportion and duration with Aroplatin/capecitabine therapy. Secondary objectives are to evaluate frequency and severity of adverse events.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Phase I Primary Objective:

  • Determine the MTD of Aroplatin/capecitabine subjects with unresectable local recurrence or distant metastases of colorectal cancer refractory to 5-FU/LV and irinotecan.

Phase II Primary Objective:

  • Evaluate the response proportion and duration with Aroplatin/capecitabine therapy.

Phase II Secondary Objective:

  • Evaluate the frequency of adverse events.

Study Type

Interventional

Enrollment

105

Phase

  • Phase 2
  • Phase 1

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:

  • Histologically confirmed colorectal cancer: unresectable local recurrence or distant metastases;
  • Measurable disease (RECIST criteria);
  • Refractory to 5-FU / leucovorin and irinotecan as described below;
  • No prior therapy with oxaliplatin, any other platinum or capecitabine;
  • ECOG score 0-2 (Karnofsky 100-70%);
  • Life expectancy of greater then or equal to 5 months;
  • Adequate hematopoietic, liver and renal function;
  • Women of child-bearing potential have to practice adequate contraception;
  • Signed written informed consent;
  • Subjects must be willing to be followed during the course of treatment/observation and follow-up.

Refractory metastatic colorectal cancer

The following subjects are regarded refractory to treatment:

  • Those with progression while receiving 5-FU/LV/irinotecan;
  • Those with progression on irinotecan after prior 5-FU/LV treatment;
  • Progression within six months of adjuvant 5-FU/LV/irinotecan;
  • Progression within six months of adjuvant 5-FU/LV followed by progression on irinotecan

Subjects must have received at least one or more commonly used 5-FU/leucovorin and irinotecan regimens. Prior adjuvant therapy is allowed including 5-FU/leucovorin or other fluoropyrimidines except capecitabine and irinotecan.

Exclusion criteria:

  • Previously diagnosed brain metastases if symptomatic and requiring active therapy;
  • Other cancers within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin;
  • Concurrent chemotherapy or immunotherapy;
  • Prior therapy for colorectal cancer within one month of admission to the present study;
  • Primary or secondary immunodeficiency or use of corticosteroids or other immunosuppressive medication;
  • Any serious concomitant medical or mental illness requiring intense therapy and interfering with participation in this study;
  • Women must not be pregnant or breast-feeding;
  • No participation in any clinical trial involving investigational drugs within 1 month from enrollment into the present study.

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: Crossover Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aronex Pharmaceuticals

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

April 15, 2004

First Submitted That Met QC Criteria

April 19, 2004

First Posted (Estimate)

April 20, 2004

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

Other Study ID Numbers

  • C-726-03

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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