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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining carboplatin and gemcitabine in treating patients who have advanced solid tumors.
OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and carboplatin in patients with advanced solid tumors. II. Determine the dose-limiting toxic effects of this regimen in these patients. III. Evaluate the pharmacokinetics and pharmacodynamics of this regimen in these patients. IV. Determine the observed responses in these patients receiving this regimen.
OUTLINE: This is a dose-escalation study of gemcitabine. Patients are stratified according to prior therapy (no prior chemotherapy and/or prior radiotherapy to less than 20% of bone marrow vs prior chemotherapy and/or prior radiotherapy to at least 20% of bone marrow). Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-3 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity. Patients are followed for survival.
PROJECTED ACCRUAL: A maximum of 18 patients (9 per stratum) will be accrued for this study.
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
carboplatin, gemcitabine hydrochloride
Fox Chase Cancer Center
Fox Chase Cancer Center
Published on BioPortfolio: 2014-08-27T03:56:42-0400
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and flavopiridol, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug ...
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Ph...
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A solid, unencapsulated tumor of the KIDNEY composed of spindle mesenchymal cells that resemble FIBROBLASTS or muscle cells. The homogeneous mass typically extends into the renal parenchyma and replaces most of the kidney. In most cases, mesoblastic nephroma is benign and occurs in the fetus or newborn, and rarely in the older child or the adult.
A transplantable, poorly differentiated malignant tumor which appeared originally as a spontaneous breast carcinoma in a mouse. It grows in both solid and ascitic forms.
An organoplatinum compound that possesses antineoplastic activity.
A malignant cystic or semisolid tumor most often occurring in the ovary. Rarely, one is solid. This tumor may develop from a mucinous cystadenoma, or it may be malignant at the onset. The cysts are lined with tall columnar epithelial cells; in others, the epithelium consists of many layers of cells that have lost normal structure entirely. In the more undifferentiated tumors, one may see sheets and nests of tumor cells that have very little resemblance to the parent structure. (Hughes, Obstetric-Gynecologic Terminology, 1972, p184)
A solid tumor consisting of a dense infiltration of MAST CELLS. It is generally benign.
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