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| Sponsored by: |
Wellstat Therapeutics |
|---|---|
| Information provided by: | Wellstat Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00044785 |
Purpose
CPT-11 and 5Fluorouracil (5FU) combined with leucovorin has become the standard of care for colorectal cancer. PN401 permits treatment with higher than normal doses of 5FU, which could increase its therapeutic potential. It is hypothesized that adding PN401 to the CPT-11, 5FU, leucovorin regimen will reduce toxicity and will allow higher doses of 5FU to be well tolerated and therefore potentially increase effectiveness.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: triacetyluridine Drug: fluorouracil Drug: leucovorin Drug: camptosar |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I Study of Escalating Doses of CPT-11 and 5fluorouracil (5FU) Plus PN401 With a Fixed Dose of Leucovorin in Patients With Solid Tumor Malignancies. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Hematopoietic: ANC = 1500/ul or more, Platelets = 100,000/ul or more, Hemoglobin = 9.5 g/dL or more, transfusion prior to evaluation is allowed; Hepatic: Bilirubin = 2.0 mg/dL or less and SGPT(ALT) and SGOT(AST) < 3 x upper limit of normal (< 5 x upper limit of normal if liver metastases present) Renal: Serum Creatinine < 2.0 mg/dL;
Exclusion Criteria
Contacts and Locations
More Information
| Study ID Numbers: | 401.02.001, GCC0121 |
| Study First Received: | September 4, 2002 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00044785 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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colorectal cancer gastric cancer breast cancer |
|
Antimetabolites Vitamin B Complex Immunologic Factors Irinotecan Breast Neoplasms Leucovorin Trace Elements Folinic Acid |
Immunosuppressive Agents Stomach Neoplasms Fluorouracil Vitamins Micronutrients Stomach Cancer Colorectal Neoplasms |
|
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Leucovorin Immunosuppressive Agents Pharmacologic Actions Fluorouracil Therapeutic Uses Vitamins Micronutrients |