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RATIONALE: Drugs used in chemotherapy, such as alvocidib, oxaliplatin, fluorouracil, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving alvocidib together with oxaliplatin with or without fluorouracil and leucovorin calcium may kill more tumor cells.
PURPOSE: This phase II trial is studying alvocidib and oxaliplatin to see how well they work when given with or without fluorouracil and leucovorin calcium in treating patients with relapsed or refractory germ cell tumors.
- To evaluate the antitumor efficacy of alvocidib and oxaliplatin with or without fluorouracil and leucovorin calcium in patients with relapsed or refractory germ cell tumors.
- To further evaluate the safety of these regimens in these patients.
- To evaluate the time to tumor response and progression-free survival of patients treated with these regimens.
- To explore the association between treatment response and p21, p53, and apoptotic markers.
OUTLINE: Patients are initially enrolled in part A. Depending on response to treatment, additional patients may be enrolled in part B.
- Part A (alvocidib and oxaliplatin): Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
- Part B (alvocidib and FOLFOX): Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples may be collected periodically for further laboratory analysis.
After completion of study treatment, patients are followed up every 4-8 weeks.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Extragonadal Germ Cell Tumor
FOLFOX regimen, alvocidib, fluorouracil, leucovorin calcium, oxaliplatin
University of Chicago Cancer Research Center
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:20:04-0400
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, capecitabine, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Co...
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. It is not ye...
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...
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 and giving the drugs in different combi...
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The active metabolite of FOLIC ACID. Leucovorin is used principally as its calcium salt as an antidote to folic acid antagonists which block the conversion of folic acid to folinic acid.
A folate analog consisting of the pharmacologically active isomer of LEUCOVORIN.
Signal transduction mechanisms whereby calcium mobilization (from outside the cell or from intracellular storage pools) to the cytoplasm is triggered by external stimuli. Calcium signals are often seen to propagate as waves, oscillations, spikes, sparks, or puffs. The calcium acts as an intracellular messenger by activating calcium-responsive proteins.
Intracellular signaling peptides and proteins that bind to CALCIUM. They undergo allosteric changes when bound to CALCIUM that affects their interaction with other signal-transducing molecules. They differ from CALCIUM-SENSING RECEPTORS which sense extracellular calcium levels.
A class of G-protein-coupled receptors that react to varying extracellular CALCIUM levels. Calcium-sensing receptors in the PARATHYROID GLANDS play an important role in the maintenance of calcium HOMEOSTASIS by regulating the release of PARATHYROID HORMONE. They differ from INTRACELLULAR CALCIUM-SENSING PROTEINS which sense intracellular calcium levels.
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...