Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Lipid Regulating Agents

Hematinics

Herbal and Botanical

Vitamins

Irinotecan

Leucovorin

Fluorouracil

Atorvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Anticholesteremic Agents

Hypolipidemic Agents

Cola

Folate

Vitamin B9

ARM A subjects will receive atorvastatin 20 mg orally once daily given for two weeks prior to FOLFIRI. The last dose of atorvastatin will be taken day 1 of FOLFIRI. ARM A will then receive no statin for the next 2 weeks. Patients will receive FOLFIRI infusion on day 1 and day 15. Blood samples will be collected at baseline and periodically through 24 hours on day 1 and 15 of FOLFIRI.

ARM B subjects will receive no atorvastatin prior to day 1 of FOLFIRI. ARM B subjects will receive atorvastatin 20 mg orally once daily for two weeks prior to day 15 of FOLFIRI. The last dose of atorvastatin will be taken day 15 of FOLFIRI. Patients will receive FOLFIRI infusion on day 1 and day 15. Blood samples will be collected at baseline and periodically through 24 hours on day 1 and 15 of FOLFIRI.

All patients will receive FOLFIRI infusion on day 1 and day 15.

FOLFIRI.

A subjects will receive atorvastatin 20 mg orally once daily given for two weeks starting on Day -14 during PERIOD ONE. ARM A will then receive no statin during PERIOD TWO. ARM B subjects will receive no atorvastatin during PERIOD ONE. ARM B subjects will receive atorvastatin 20 mg orally once daily for two weeks during PERIOD TWO (starting on Day 2). One cycle = 28 days.

Autumn McRee, MD

The purpose of this study is to evaluate the effect of atorvastatin on the pharmacokinetic profile of irinotecan and SN-38. To further evaluate the safety of atorvastatin in combination with FOLFIRI. To further evaluate the safety and of irinotecan in combination with atorvastatin.

This is a single-center, prospective, randomized, crossover study to address the pharmacokinetic effects of atorvastatin on irinotecan metabolism in patients receiving their first cycle of FOLFIRI (5-fluorouracil + leucovorin + irinotecan).

Each cycle of FOLFIRI is defined as 28 days, with a dose of FOLFIRI administered on day 1 and day 15. Patients will be recruited from the UNC Lineberger Cancer Center, referred by their primary oncologist for the treatment of metastatic colorectal cancer (mCRC). After obtaining informed consent, the patient will be randomized to either ARM A or ARM B.

Blood samples will be collected on day 1 and 15 of FOLFIRI prior to treatment with irinotecan (baseline), immediately following the end of the irinotecan infusion, and at 0.5, 1, 1.5, 2, 4, 6, and 24 hours following the end of the irinotecan infusion.

ARM A subjects will receive atorvastatin 20 mg orally once daily given for two weeks starting on Day -14 during PERIOD ONE. ARM A will then receive no statin during PERIOD TWO. Patients will receive FOLFIRI infusion on day 1 and day 15. Blood samples will be collected at baseline and periodically through 24 hours.

ARM B subjects will receive no atorvastatin during PERIOD ONE. ARM B subjects will receive atorvastatin 20 mg orally once daily for two weeks during PERIOD TWO (starting on Day 2). Patients will receive FOLFIRI infusion on day 1 and day 15. Blood samples will be collected at baseline and periodically through 24 hours.

DNA extraction and genetic analysis of UGT1A1 polymorphisms will be performed in collaboration with Dr. Federico Innocenti and those patients homozygous for the UGT1A1\*28 allele will be excluded due to their altered irinotecan metabolism.

Patients will be followed until Day 1 of Cycle 2 of FOLFIRI. Patients removed from study for unacceptable adverse events will be followed until resolution or stabilization of the event(s).

Crossover Evaluation of Effect of Atorvastatin on PK of Irinotecan in CRC Patients Receiving FOLFIRI

A Prospective, Randomized, Crossover Evaluation of the Effect of Atorvastatin on the Pharmacokinetics of Irinotecan in Colorectal Cancer Patients Receiving FOLFIRI

At the end of the screening period, eligible patients will be randomly assigned in a 1:1 ratio to receive atorvastatin prior to Day 1 of FOLFIRI (ARM A) or atorvastatin prior to Day 15 FOLFIRI (ARM B). Patients in ARM A must start atorvastatin within 28 days of randomization and patients in ARM B should receive FOLFIRI within 28 days of randomization; if not, the Investigator must be notified.

UNC Lineberger Comprehensive Cancer Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Bone Density Conservation Agents

Zoledronic Acid

Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily

Zoledronate

Shi-Ming Tu, MD

Objectives:

Primary:

Evaluate clinical outcome based on the time to skeletal events after bone-targeted therapy

Secondary:

1. Evaluate clinical outcome based on the presence of calcification at the site of osteolytic metastases
2. Measure bone-formation and resorption markers at baseline and during bone-targeted therapy.
3. Assess effect of the bone-targeted regimen on serum cholesterol levels

Kidney cancer often spreads (metastases) to the bones. Zoledronate is designed to protect the bones from pain and from breaking as a result of cancer. Atorvastatin is a drug that lowers cholesterol levels in the blood. Combining these medications may make zoledronate more effective.

If you are found to be eligible to take part in this study, you will be given zoledronate intravenously (IV--through a needle in your vein) over fifteen minutes,1 time every 4 weeks. You will take a pill, atorvastatin, by mouth once time a day every day that you are on the study. Every 4 weeks is considered 1 study "cycle".

You will need to return to M. D. Anderson for check-ups every 8 -12 weeks. Urine will be collected for routine tests. You will have x-rays, bone scans, and/or CT scans to check on the status of the disease.

You will receive at least 2 cycles of treatment unless intolerable side effects occur or your disease gets worse. You may receive more than 2 cycles if you are benefitting from the study drugs.

You will be followed every 8 weeks for up to 1 year for skeletal events (symptoms related to disease moving to or getting worse in your bones). You will be taken off study if you experience a skeletal event or at the end of the 1-year monitoring period. Monitoring may be done with a local doctor or at M. D. Anderson. No extra testing or procedures are needed during this period.

This is an investigational study. The combination of the 2 drugs given in this study is investigational for the treatment of bone metastases. Zoledronate is approved for the treatment of bone metastases. Atorvastatin has been approved by the FDA for lowering cholesterol. About 38 patients will take part in this study. All will be enrolled at M. D. Anderson.

Zoledronate With Atorvastatin in Renal Cell Carcinoma

Bone-Targeted Therapy Combining Zoledronate With Atorvastatin in Renal Cell Carcinoma: A Phase II Study

Time to skeletal events, defined as a metastatic site requiring radiotherapy or any surgical intervention (eg, embolization, radiofrequency ablation, intrathecal catheter placement) or complications from skeletal metastatic lesions (eg, pathologic fracture, spinal cord compression). Time to skeletal events monitored every 8 weeks for at least 1 year.

Novartis Pharmaceuticals

M.D. Anderson Cancer Center

"Definitely" and "Probably" related World Health Organization (WHO)classification grade 1 and 2 adverse events were reported.

Zoledronate + Atorvastatin

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Shi-Ming Tu, MD / Professor

Four participants did not experience skeletal events.

Median Time to First Skeletal-related Event

Overall Study

Symptoms and General Pathology

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Gonadal Disorders

Endocrine System Diseases

Lipitor

Placebo

Richard S Legro, MD

The purpose of this study is to determine the efficacy of Lipitor (Atorvastatin) for the treatment of PCOS with elevated LDL cholesterol.

The investigators hypothesize that improving the lipid profile with atorvastatin will improve vascular function, increase the frequency of ovulation, decrease androgen levels, improve insulin sensitivity, and improve the lipid profile more efficiently than placebo.

A Trial of Lipitor (Atorvastatin) for the Treatment of Polycystic Ovary Syndrome (PCOS) in Women With Elevated Low-density Lipoprotein (LDL) Cholesterol

A Six-week Double Blinded, Randomized Trial of Atorvastatin for the Treatment of PCOS Women With Elevated LDL Cholesterol

high sensitive C-reactive protein as a measure of inflammation

Brachial artery FMD, the percent change in brachial artery diameter following release of transient occlusion, was selected as the primary outcome because it is the most widely used research tool for evaluating the effects of interventions on endothelial function. FMD has been shown to predict longterm cardiovascular events, even in patients with no apparent heart disease.

Pneumatic cuffs were positioned on the upper arm and wrist of the experimental arm. The brachial artery was imaged using an ATL Doppler ultrasound probe (5-12MHz linear array scanhead, HDI 5000, Advanced Technology Laboratories, Bothell, WA). Mean blood flow velocity (MBV) and brachial artery diameter (BAD) were recorded at baseline. Then the wrist cuff was inflated to 200-250 mmHg. After a minute, with the wrist cuff still inflated, the arm cuff was inflated to 200-250 mmHg. After 10 minutes the arm cuff was released to induce reactive hyperemia in the brachial artery. Upon release of the arm cuff, we continuously measured blood pressure (BP), heart rate (HR), and MBV, and intermittently measured BAD in the experimental arm. Brachial artery conductance (BAC)was calculated as MBV/MAP and FMD was calculated as percent change in BAD from baseline.

A 75 gram oral glucose tolerance test (OGTT) was performed with blood draws at 0, 30, 60, 90 and 120 minutes.

Area under the curve for insulin during OGTT: A 75 gram oral glucose tolerance test was performed with blood draws at 0, 30, 60, 90 and 120 minutes.

Milton S. Hershey Medical Center

Professor, Obstetrics and Gynecology and Public Health Sciences

Total

Age, Categorical

Richard S. Legro

This study was initiated as a pilot study with the goal of enrolling 19 women in each group, which we hypothesized would provide 80% power to detect an absolute difference in the change in FMD from baseline between the two groups (Atorvastatin vs. Placebo) of 3.75%, assuming a common standard deviation (SD) of 4%, using a two-sided, two-sample t-test with α=0.05. Recruitment was slow due to strict inclusion/ exclusion criteria so we analyzed our data after the first 20 women completed the study.

Before treatment

After treatment

All analyses were performed by intention-to-treat.

Brachial Artery Flow-mediated Dilation (FMD)

What is being compared for this analysis is the change from baseline for "Atorvastatin" to the change from baseline for "Placebo."

Peak Brachial Artery Conductance (BAC)

Total Cholesterol

LDL Cholesterol

HDL Cholesterol

Triglycerides

Fasting Glucose

Fasting Insulin

Area Under the Curve (AUC) for Glucose During OGTT

AUC for Insulin

Total Testosterone

Androstenedione

DHEAS

High-sensitivity C-reactive Protein (hsCRP)

Systolic Blood Pressure

Diastolic Blood Pressure

Pelvic ultrasound was performed using the 6.5 megahertz (MHz) probe of an ATL 400 machine to characterize ovarian size and morphology. Since in vitro studies demonstrate that statins inhibit ovarian theca-interstitial cell proliferation, we hypothesized that statins might reduce ovarian volume in PCOS.

Mean Ovarian Volume

Body Mass Index

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Crossover Evaluation of Effect of Atorvastatin on PK of Irinotecan in CRC Patients Receiving FOLFIRI	NCT01605344	Advanced Adenoc...	FOLFIRI. Atorvastatin	18 Years -	UNC Lineberger Comprehensive Cancer Center
Crossover Evaluation of Effect of Atorvastatin on PK of Irinotecan in CRC Patients Receiving FOLFIRI	NCT01605344	Advanced Adenoc...	FOLFIRI. Atorvastatin	18 Years -	UNC Lineberger Comprehensive Cancer Center
Zoledronate With Atorvastatin in Renal Cell Carcinoma	NCT00490698	Kidney Cancer Renal Cell Carc...	Zoledronate Atorvastatin	-	M.D. Anderson Cancer Center
Zoledronate With Atorvastatin in Renal Cell Carcinoma	NCT00490698	Kidney Cancer Renal Cell Carc...	Zoledronate Atorvastatin	-	M.D. Anderson Cancer Center
A Trial of Lipitor (Atorvastatin) for the Treatment of Polycystic Ovary Syndrome (PCOS) in Women With Elevated Low-density Lipoprotein (LDL) Cholesterol	NCT00529542	Polycystic Ovar...	Lipitor Placebo	18 Years - 40 Years	Milton S. Hershey Medical Center

Spots Global Cancer Trial Database for lipitor

Every month we try and update this database with for lipitor cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lipitor

Every month we try and update this database with for lipitor cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lipitor cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.