GW786034 in Treating Patients With Advanced Solid Tumors

NCT00060151 | Completed Phase 1

• 7 other identifiers: CDR0000299531CASE-CWRU-100231GSK-VEG10003GSK-RM2002/00345/02CWRU-GLAX-1Y02CWRU-1Y02CASE-100231
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Safety and toxicity assessed weekly during treatment

Secondary Outcomes (1)

• Disease response every 9 weeks

Interventions

pazopanib hydrochloride DRUG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Related Publications (1)

• Hurwitz HI, Dowlati A, Saini S, Savage S, Suttle AB, Gibson DM, Hodge JP, Merkle EM, Pandite L. Phase I trial of pazopanib in patients with advanced cancer. Clin Cancer Res. 2009 Jun 15;15(12):4220-7. doi: 10.1158/1078-0432.CCR-08-2740. Epub 2009 Jun 9.

  PMID: 19509175 RESULT

Study Officials

• Afshin Dowlati, MD

  Case Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2003
• First Posted: May 7, 2003
• Study Start: December 1, 2002
• Study Completion: June 1, 2009
• Last Updated: September 20, 2013

Record last verified: 2006-04

Locations

US (2)