Trial record 27 of 159 for: colon cancer AND Capecitabine AND Fluorouracil
Aroplatin and Capecitabine in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00081536|
Recruitment Status : Unknown
Verified April 2004 by Aronex Pharmaceuticals.
Recruitment status was: Active, not recruiting
First Posted : April 20, 2004
Last Update Posted : June 24, 2005
Information provided by:
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Drug: Aroplatin (Liposomal NDDP) in combination with capecitabine||Phase 1 Phase 2|
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 (Clinical Trial)|
|Enrollment :||105 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
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