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Sponsored by: |
Aronex Pharmaceuticals |
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Information provided by: | Aronex Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00043199 |
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.
Condition | Intervention | Phase |
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Colorectal Neoplasms |
Drug: Aroplatin (Liposomal NDDP, L-NDDP) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 40 |
Primary Objective:
Secondary Objective:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | C-726-01 |
Study First Received: | August 6, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00043199 |
Health Authority: | United States: Food and Drug Administration |
Colorectal Neoplasms Colorectal Cancer Colorectal Carcinoma Colorectal Tumor |
Neoplasms, Colorectal Unresectable Metastatic Refractory |
Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Leucovorin Intestinal Diseases Rectal Diseases |
Recurrence Intestinal Neoplasms Carcinoma Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site |