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Sponsored by: |
Aronex Pharmaceuticals |
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Information provided by: | Aronex Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00081536 |
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 | Intervention | Phase |
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Colorectal Neoplasms |
Drug: Aroplatin (Liposomal NDDP) in combination with capecitabine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 105 |
Phase I Primary Objective:
Phase II Primary Objective:
Phase II Secondary Objective:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Study ID Numbers: | C-726-03 |
Study First Received: | April 15, 2004 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00081536 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Colorectal Neoplasms Colorectal Cancer Colorectal Carcinoma Colorectal Tumor |
Neoplasms, Colorectal Unresectable Metastatic Refractory |
Antimetabolites Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Irinotecan Colonic Diseases Leucovorin Folinic Acid Intestinal Diseases |
Rectal Diseases Recurrence Intestinal Neoplasms Carcinoma Digestive System Diseases Fluorouracil Neoplasm Metastasis Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Capecitabine Digestive System Neoplasms Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Pharmacologic Actions Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms |