Aroplatin and Capecitabine in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies
Recruitment status was Active, not recruiting
Tracking Information | |
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First Received Date ICMJE | April 15, 2004 |
Last Updated Date | June 23, 2005 |
Start Date ICMJE | |
Primary Completion Date | |
Current Primary Outcome Measures ICMJE | |
Original Primary Outcome Measures ICMJE | |
Change History | Complete list of historical versions of study NCT00081536 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE | |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Aroplatin and Capecitabine in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies |
Official Title ICMJE | 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 |
Brief Summary | 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. |
Detailed Description | Phase I Primary Objective:
Phase II Primary Objective:
Phase II Secondary Objective:
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Study Type ICMJE | Interventional |
Study Phase | Phase 1 Phase 2 |
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
Condition ICMJE | Colorectal Neoplasms |
Intervention ICMJE | Drug: Aroplatin (Liposomal NDDP) in combination with capecitabine |
Study Arm (s) | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Active, not recruiting |
Enrollment ICMJE | 105 |
Completion Date | |
Primary Completion Date | |
Eligibility Criteria ICMJE | Inclusion criteria:
Refractory metastatic colorectal cancer The following subjects are regarded refractory to treatment:
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:
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Gender | Both |
Ages | 18 Years and older |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | |
Administrative Information | |
NCT Number ICMJE | NCT00081536 |
Other Study ID Numbers ICMJE | C-726-03 |
Has Data Monitoring Committee | |
Responsible Party | |
Study Sponsor ICMJE | Aronex Pharmaceuticals |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Aronex Pharmaceuticals |
Verification Date | April 2004 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |