GW786034 in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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: This phase I trial is studying the side effects and best dose of GW786034 in treating patients with advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)

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