Ixabepilone and Sunitinib Malate in Treating Patients With Progressive Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of ixabepilone when given together with sunitinib malate in treating patients with progressive advanced solid tumors.

Key facts

Study ID

NCT00884676

Run by

Jaime Merchan

People needed

36

Starts

2008-11-01

Expected to finish

2015-07-01

Last updated by the study team

2015-10-09

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Non-hematological malignancy that has progressed on standard therapy.
• Age > 18.
• ECOG Performance Status (PS) 0, 1, or 2.
• Life expectancy of > 3 months.
• More than three prior systemic therapy regimens (a period of 4 weeks from chemotherapy or immunotherapy ("washout period"), must have elapsed; and 2 weeks for prior tyrosine kinase inhibitors).
• Prior treatment with sunitinib in a 4 weeks on/2weeks off schedule is acceptable.
• Women of Child Bearing Potential (WOCBP) must use adequate method of contraception throughout and up to 4 weeks after the study.
• Patients must have either measurable disease (defined in Section 9.0) or evaluable disease (bony lesions, pleural effusion, ascites)
• Required laboratory values obtained <= 7 days prior to registration:
• Granulocytes (ANC) >= 1500/mm3
• PLT >= 100,000/mm3
• Hgb >= 9.0 g/dL
• Direct bilirubin <= 1.0 x ULN
• Alkaline phosphatase <= 2.5 x ULN (<= 5 x if liver metastasis is present)
• AST/ALT <= 2.5 x ULN (<= 5 x if liver metastasis is present)
• Creatinine < 1.5 x ULN
• Pregnancy Test Negative (For WOCBP*)
• Urinalysis - Urine protein/creatinine ratio < 1, or < 1+ protein**
• TSH = WNL
• INR <= 1.5, unless the patient is on full dose warfarin or stable dose of LMW heparin with a therapeutic INR of > 1.5, <= 3.
• Urine protein should be screened by random urine protein:creatinine ratio. For urine protein: creatinine ratio >1.0, 24-hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment.
• Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent.
• Willingness to donate blood for correlative marker studies.
• If a patient is on full-dose anticoagulants, the following criteria should be met for enrollment:
• The subject must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on stable dose of LMW heparin.

You may not qualify if…

• Patients with symptomatic/untreated CNS metastases. Patients with known CNS metastases can be enrolled if:
• CNS metastases have been appropriately treated. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or resection as deemed appropriate by the treating physician. Patients who had surgical resection of CNS metastases or brain biopsy within 3 months prior to Day 1 will be excluded.
• No ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.
• No evidence of progression or hemorrhage after treatment (brain imaging study within 4 weeks of treatment start).
• CTC Grade 2 or greater neuropathy (motor or sensory) at study entry.
• Inability to swallow capsules.
• History of gastrointestinal disease, malabsorption, or requiring use of a feeding tube.
• Patients who have received any investigational compound within the past 28 days (within 2 weeks for prior RTKI treated patients).
• Patients who have received radiotherapy for any cause less than 4 weeks prior to study entry.
• Patients taking cytochrome P450 (CYP) 3A4 enzyme-inducing or enzyme-inhibitor medications like: antiepileptic drugs (phenytoin, carbamazepine or phenobarbital), St John's Wort, ketoconazole, dexamethasone, dysrhythmic drugs (terfenadine, quinidine, procainamide, sotalol, probucolol, bepridil, indapamide, or flecainide), haloperidol, risperidone, rifampin, grapefruit (or juice) within two weeks of registration and during the course of therapy. Topical and inhaled steroids are permitted. Please refer to Appendix VI for a complete list of CYP34A inducers and inhibitors.
• Patients with known HIV infection are excluded due to the possibility of unknown side effects on the immune system by these agents. The potential impact of pharmacokinetic interactions of anti-retroviral therapy with ixabepilone or sunitinib is unknown. Appropriate studies may be undertaken in patients with HIV and those receiving combination anti-retroviral therapy in the future.
• Invasive procedures defined as follows:
• Major surgical procedure, open biopsy or significant traumatic injury <= 28 days prior to registration.
• Anticipation of need for major surgical procedures during the course of the study.
• Core biopsy <= 7 days prior to registration.
• Port placement <= 7 days prior to registration.
• Serious or non-healing wound, ulcer or bone fracture.
• History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess <= 28 days.
• Evidence of bleeding diathesis or coagulopathy.
• Ongoing hemoptysis, or cerebrovascular accident <= previous 6 months, or peripheral vascular disease with claudication on < 1 block, or history of clinically significant bleeding.
• Significant cardiovascular disease defined as congestive heart failure (New York Heart Association Class II, III or IV), angina pectoris requiring nitrate therapy, or recent myocardial infarction (<= the last 6 months). Patients must have an absolute baseline left ventricular ejection fraction (LVEF) >= 50% by MUGA scan within 4 weeks prior to registration
• Uncontrolled hypertension (defined as a blood pressure of > 150 mmHg systolic and/or > 90 mmHg diastolic on medication).
• A currently active second malignancy other than non-melanoma skin cancer. Patients are not considered to have a currently active malignancy if they have completed anti-cancer therapy and are considered by their physician to be at less than 30% risk of relapse.
• Any of the following, as this regimen may be harmful to a developing fetus or nursing child:
• Pregnant women

Where it is running

• University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States

Full record on ClinicalTrials.gov

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