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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.
OBJECTIVES: I. Establish the safety of VX-710 in combination with doxorubicin and vincristine in patients with recurrent small cell lung cancer. II. Characterize the plasma pharmacokinetics of this regimen in these patients. III. Establish the ability of this regimen to improve the response rate to chemotherapy in these patients who have relapsed on front line therapy. IV. Evaluate the multidrug resistance profile of these patients in response to this regimen.
OUTLINE: This is a multicenter study. Stage I: Patients receive VX-710 IV over 72 hours, followed by doxorubicin IV and vincristine IV four hours after initial VX-710. Vincristine is administered at half dose in the first 3-6 patients. If no more than 1 of 6 patients experiences dose limiting toxicity in the half dose cohort, 3 additional patients receive full dose vincristine. The maximum tolerated dose is defined as the dose preceeding that at which 2 of 6 patients experience dose limiting toxicity. Stage II: Patients receive VX-710 IV over 72 hours, followed by doxorubicin IV and full dose vincristine IV four hours after initial VX-710. Treatment continues for up to 6 courses every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for up to 1 year.
PROJECTED ACCRUAL: A minimum of 35 and a maximum of 92 patients will be accrued for this study.
Primary Purpose: Treatment
biricodar dicitrate, doxorubicin hydrochloride, vincristine sulfate
University of Arkansas for Medical Sciences
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-24T14:35:54-0400
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of inhaled doxoru...
Ofatumumab in Combination With Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate, and Dexamethasone Alternating With Ofatumumab in Combination With Cytarabine and Methotrexate in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
This phase II trial studies how well ofatumumab in combination with cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and dexamethasone alternating with ofatumumab in combi...
This phase II trial studies how well etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride with asparaginase work in treating patients with acute lymp...
To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established therapy A...
RATIONALE: Drugs used in chemotherapy, such as topotecan and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from div...
To compare the pharmacokinetic bioequivalence and safety of a generic pegylated liposomal doxorubicin formulation (SPIL DXR hydrochloride liposome injection) with that of the reference products, Caely...
Doxorubicin is one of the most active agents in the first-line therapy for metastatic breast cancer, but its utility is partially limited by the frequent emergence of doxorubicin resistance. In this s...
Clinical use of doxorubicin, an effective chemotherapeutic agent, has limited uses due to dose-dependent cardiac toxicity. It has been supposed that the production of free radicals and calcium ions ov...
Lung cancer is the leading cause of cancer death in Germany. Although several randomized trials in Europe have evaluated the effectiveness of lung cancer screening programs, evidence on the cost-effec...
A quinazoline derivative and ANTINEOPLASTIC AGENT that functions as a PROTEIN KINASE INHIBITOR for EGFR associated tyrosine kinase. It is used in the treatment of NON-SMALL CELL LUNG CANCER.
Derivatives of chondroitin which have a sulfate moiety esterified to the galactosamine moiety of chondroitin. Chondroitin sulfate A, or chondroitin 4-sulfate, and chondroitin sulfate C, or chondroitin 6-sulfate, have the sulfate esterified in the 4- and 6-positions, respectively. Chondroitin sulfate B (beta heparin; DERMATAN SULFATE) is a misnomer and this compound is not a true chondroitin sulfate.
An enzyme that catalyzes the activation of sulfate ions by ATP to form adenosine-5'-phosphosulfate and pyrophosphate. This reaction constitutes the first enzymatic step in sulfate utilization following the uptake of sulfate. EC 22.214.171.124.
Tumors or cancer of the LUNG.
A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Methadone is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
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...