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Home > "G" Clinical Trials Conditions > GW786034 in Treating Patients With Advanced Solid Tumors  GW786034 in Treating Patients With Advanced Solid Tumors
GW786034 in Treating Patients With Advanced Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: GW786034 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of GW786034 in treating patients who have advanced solid tumors.
Details: OBJECTIVES: - Determine the safety and tolerability of GW786034 in patients with advanced solid tumors. - Determine the maximum tolerated dose of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine the clinical response in patients treated with this drug. - Evaluate the effect of this drug on biomarkers of angiogenesis activity in order to estimate activity and to determine the minimum biologically active dose in these patients. OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study. Patients receive oral GW786034 twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 2-6 patients receive escalating doses of GW786034 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 21 days. PROJECTED ACCRUAL: Approximately 30-50 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 21 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed advanced solid tumor - Refractory to standard therapy or for which no standard therapy exists - No untreated leptomeningeal or brain metastases - Previously treated brain metastases are allowed if currently asymptomatic and patient is off steroids and antiseizure medications for more than 3 months before study entry PATIENT CHARACTERISTICS: Age - 21 and over Performance status - Karnofsky 70-100% Life expectancy - At least 12 weeks Hematopoietic - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic - Bilirubin no greater than 1.5 mg/dL - AST and ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if tumor involvement) Renal - Creatinine clearance at least 60 mL/min Cardiovascular - No uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg on 2 consecutive measurements separated by 1 week) - No arterial or venous thrombosis (including cerebrovascular accident) within the past 3 months - No myocardial infarction within the past 3 months - No unstable angina within the past 3 months - No cardiac angiopathy or stenting within the past 3 months - No cardiac pacemaker Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 21 days after study treatment - Able to swallow and retain oral medication - Good venous access - No prior or concurrent gastrointestinal disease - No prior or concurrent condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs - No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug - No other unstable, pre-existing major medical condition - No orthopedic pins or rods or other embedded metal that would preclude undergoing an MRI - No psychological, familial, sociological, or geographical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior immunotherapy - Concurrent epoetin alfa allowed - No concurrent anticancer biologic therapy Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No concurrent anticancer cytotoxic chemotherapy Endocrine therapy - See Disease Characteristics - More than 4 weeks since prior hormonal or steroid therapy (other than replacement) - No concurrent anticancer hormonal therapy (except for replacement) - No concurrent dexamethasone or prednisone Radiotherapy - More than 4 weeks since prior radiotherapy - No concurrent anticancer radiotherapy Surgery - More than 4 weeks since prior major surgery - No concurrent surgery for cancer Other - Recovered from prior therapy - More than 4 weeks since prior investigational agents - More then 28 days since prior alteration of antihypertensive medications - Concurrent bisphosphonates allowed - No other concurrent anticancer therapy - No concurrent antidepressants (e.g., amitriptyline, fluoxetine, or fluvoxamine) - No concurrent oral hypoglycemics (e.g., glipizide, glyburide, rosiglitazone, or tolbutamide) - No concurrent therapeutic anticoagulation (e.g., warfarin at therapeutic doses) - Low-dose anticoagulation for prophylaxis allowed - No concurrent cyclosporine - No concurrent grapefruit juice - No concurrent amiodarone, mibefradil, phenobarbital, or pioglitazone - No concurrent Hypericum perforatum (St. John's Wort) - No concurrent rifabutin or diethyldithiocarbamate - No concurrent gestodene, mifepristone, or modafinil - No concurrent herbal supplements, vitamins, or non-traditional compounds
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AfshinDowlati, Study Chair, Ireland Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5065
United States
Recruiting Afshin Dowlati 216-844-1228
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Herbert Hurwitz 919-684-6342
Additional Information:
Study ID Numbers: CDR0000299531; CWRU-GLAX-1Y02,CWRU-1Y02,CWRU-100231,GSK-RM2002/00345/02,GSK-VEG10003
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060151
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Oxandrolone Compared With Megestrol in Preventing Weight Loss in Patients Receiving Chemotherapy for Cancer
2. Combination Chemotherapy in Treating Patients With Advanced Solid Tumors
3. Combination Chemotherapy With Suramin Plus Doxorubicin in Treating Patients With Advanced Solid Tumors
4. UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors
5. CCI-779 in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
GW786034 in Treating Patients With Advanced Solid Tumors
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