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Clinical Trial Listing

001: FOR MORE INFORMATION ON ANY OF THESE TRIALS PLEASE CALL 504-842-4481 
Call 504-842-4481 to reach the main line for the Ochsner Cancer Institute Clinical Trials Department. Leave a message with a summary of your diagnosis and/or trial interests and we will call you back as soon as possible
 
2012.090.N - Endometrial Carcinoma and the Effects of Carboplatin and Paclitaxel 
This randomized phase III trial is studying carboplatin and paclitaxel to see how well they work when given with or without cisplatin and radiation therapy in treating patients with stage I, stage II, stage III, or stage IVA endometrial cancer.
 
2013.042.C - Endometrial and Cervical Cancer and the Effect of Standard Versus Intensity-Modulated Pelvic Radiation Therapy 
This randomized phase III trial is studying two different methods of radiation and their side effects and comparing how well they work in treating endometrial and cervical cancer after surgery.
 
2013.146.B - Carcinoid Tumors and the Effects of Pazopanib vs. Placebo 

This randomized phase II trial studies how well pazopanib hydrochloride works in treating patients with progressive carcinoid tumors. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.


 
2014.197.N - Recurrent Endometrial Cancer and the Effects of Paclitaxel/Carboplatin +/- Metformin 

PRIMARY OBJECTIVES:

I. To determine if the addition of metformin (metformin hydrochloride) to the standard regimen of carboplatin and paclitaxel prolongs progression-free survival (PFS) in women with advanced or recurrent endometrial cancer. (Phase II) II. To determine if the addition of metformin to the standard regimen of carboplatin and paclitaxel prolongs overall survival (OS) in the same population if a phase III study is conducted. Both clinical trials (Phase II and III) will utilize OS as a primary endpoint if a phase III trial is opened.

SECONDARY OBJECTIVES:

I. To estimate the proportion of patients with objective response (response rate [RR]) in the population of patients with measurable disease by treatment.

II. To estimate the duration of response in the population of patients with measurable disease who respond by treatment.

III. To estimate overall survival (OS) and relative hazards of death for each treatment arm if the study stops after the phase II trial is completed. If the study continues with a phase III clinical trial, then PFS will be a secondary endpoint.

IV. To determine the nature, frequency and degree of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) for each treatment arm.

V. To estimate possible differences in RR, PFS, OS, and toxicity rates for the treatment regimens by the patients' level of obesity.

TERTIARY OBJECTIVES:

I. To explore the association of metabolic factors (i.e. body mass index [BMI], hip-to-waist ratio, diabetes status, hemoglobin A1c [HgbA1C], fasting insulin and glucose levels, homeostatic model assessment [HOMA] scores) with treatment response to metformin/paclitaxel/carboplatin.

II. To correlate expression of the metformin transporter proteins (i.e., organic cation transporters [OCT] 1-3, multidrug and toxin extrusion [MATE] 1/2 and plasma membrane monoamine transporter [PMAT]) and key targets of the metformin/mammalian target of rapamycin (mTOR) signaling pathway with treatment response to metformin/paclitaxel/carboplatin.

III. To estimate differences in physical functioning, physical activity, and fatigue between treatment arms.

IV. To explore the association between metabolic factors (i.e., BMI, hip-to-waist ratio, diabetes status, HgbA1C, fasting insulin and glucose levels, HOMA scores) and physical functioning, physical activity, and fatigue.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive paclitaxel intravenously (IV) over 3 hours on day 1, carboplatin IV over 30 minutes on day 1, and metformin hydrochloride orally (PO) twice daily (BID) on days 1-21 (once daily [QD] in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising metformin hydrochloride PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel IV and carboplatin IV as in Arm I. Patients also receive placebo PO BID on days 1-21 (QD in course 1). Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising placebo PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

 
SIGNITURE Module 5: PTCH1 or SMO Mutated Tumors and the Effect of LDE225 

The purpose of this signal seeking study is to determine whether treatment with LDE225 demonstrates sufficient efficacy in hedgehog pathway-mutated solid tumors and/or hematologic malignancies to warrant further study

 

 

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