Central Florida Cancer Institute http://cfcancerinst.com Just another Cancercenter.cc Blogs weblog Sat, 19 May 2012 16:07:42 +0000 en hourly 1 http://wordpress.org/?v=3.3.1 Impact of Genomics and Exposures on Disparities in Breast Cancer Radiosensitivity (WFU 97069) http://cfcancerinst.com/2012/05/14/impact-of-genomics-and-exposures-on-disparities-in-breast-cancer-radiosensitivity-wfu-97069/ http://cfcancerinst.com/2012/05/14/impact-of-genomics-and-exposures-on-disparities-in-breast-cancer-radiosensitivity-wfu-97069/#comments Mon, 14 May 2012 14:51:49 +0000 http://cfcancerinst.cancercenter.cc/2012/05/14/impact-of-genomics-and-exposures-on-disparities-in-breast-cancer-radiosensitivity-wfu-97069/ <h4>Objective</h4><br /><h4>Overview</h4><br /><h4>Eligibility Requirements</h4><h4>Contact Centers</h4><div id="clinic-47">University of New Mexico<br />1201 Camino de Salud NE, MSC07-4025<br />Albuquerque<br />New Mexico<br />87131<br />Valerie Parks, RN<br />ClinicalTrialInfo@salud.unm.edu<br />505-925-0390<br /><br /></div>

]]> http://cfcancerinst.com/2012/05/14/impact-of-genomics-and-exposures-on-disparities-in-breast-cancer-radiosensitivity-wfu-97069/feed/ 0 A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Liosarcoma http://cfcancerinst.com/2012/05/10/a-phase-ii-study-of-pazopanib-in-the-treatment-of-surgically-unresectable-or-metastatic-liosarcoma/ http://cfcancerinst.com/2012/05/10/a-phase-ii-study-of-pazopanib-in-the-treatment-of-surgically-unresectable-or-metastatic-liosarcoma/#comments Thu, 10 May 2012 16:38:35 +0000 http://cfcancerinst.cancercenter.cc/2012/05/10/a-phase-ii-study-of-pazopanib-in-the-treatment-of-surgically-unresectable-or-metastatic-liosarcoma/ <h4>Objective</h4><br /><h4>Overview</h4><br /><h4>Eligibility Requirements</h4>Inclusion:
1. Histologically or cytologically confirmed high-or intermediate grade liposarcoma (allowed subtypes include liposarcoma, de-differentiated, myxoid, round cell, pleomorphic, mixed-type, or not otherwise specified)
2. ECOG 0-1
3. Any number of prior treatment lines including naïve subjects is allowed
Exclusion:
1. Well differentiated liposarcoma, prior treatment with TKI’s or VEGF inhibitors
2. Prior malignancy within 3 years
3. History of clinical evidence of CNS metastasis or leptomeningeal disease unless treated and are asymptomatic and have had no requirements for steroids or anti-seizure meds for 6 months
4. Clinically significant GI abnormalities
5. Corrected QT interval > 480msec
6. History of any of the following within the last 6 months- MI, unstable angina, CABG, symptomatic PVD, Class III or IV CHF, poorly controlled hypertension > 140/90, CVA or TIA
<h4>Contact Centers</h4><div id="clinic-26">The West Clinic<br />100 N Humphreys<br />Memphis<br />Tennessee<br />38120<br />Tracy B. Stewart, RN, BSN, OCN, CCRC<br />research@westclinic.com<br />901-683-0055 ext.1236<br /><br /></div>

]]> http://cfcancerinst.com/2012/05/10/a-phase-ii-study-of-pazopanib-in-the-treatment-of-surgically-unresectable-or-metastatic-liosarcoma/feed/ 0 Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination with Custirsen (OGX-011) in Men with Metastatic Castrate Resistant Prostate Cancer http://cfcancerinst.com/2012/05/10/randomized-phase-3-study-comparing-standard-first-line-docetaxelprednisone-to-docetaxelprednisone-in-combination-with-custirsen-ogx-011-in-men-with-metastatic-castrate-resistant-prostate-cancer/ http://cfcancerinst.com/2012/05/10/randomized-phase-3-study-comparing-standard-first-line-docetaxelprednisone-to-docetaxelprednisone-in-combination-with-custirsen-ogx-011-in-men-with-metastatic-castrate-resistant-prostate-cancer/#comments Thu, 10 May 2012 16:35:57 +0000 http://cfcancerinst.cancercenter.cc/2012/05/10/randomized-phase-3-study-comparing-standard-first-line-docetaxelprednisone-to-docetaxelprednisone-in-combination-with-custirsen-ogx-011-in-men-with-metastatic-castrate-resistant-prostate-cancer/ <h4>Objective</h4><br /><h4>Overview</h4><br /><h4>Eligibility Requirements</h4>Inclusion:
1. Adenocarcinoma of the prostate requiring chemotherapy with metastatic radiographic disease defined as (20% increase in radiographic disease or at least 2 new bone lesions on bone scan or increasing PSA levels with minimum being 5.0 and rising over two consecutive weeks from baseline
2. Willing to not add, delete or change bisphosphonate or denosumab usage during study therapy
3. Subjects receiving more than 10mg of Prednisone per day at screening must be willing to have dose reduced to 10 mg per day for at least 7 days prior to randomization
Exclusion:
1. Received any other cytotoxic chemotherapy at treatment for prostate cancer
2. Received any cycling, intermittent or continuous hormonal treatment 28 days prior to randomization with the exception of lupron
3. Brain metastasis or symptomatic chord compression requiring surgery or radiation therapy
4. Uncontrolled medical conditions such as heart failure, Mi, uncontrolled hypertension, stroke or treatment of a major active infection within 3 months of randomization
<h4>Contact Centers</h4><div id="clinic-26">The West Clinic<br />100 N Humphreys<br />Memphis<br />Tennessee<br />38120<br />Tracy B. Stewart, RN, BSN, OCN, CCRC<br />research@westclinic.com<br />901-683-0055 ext.1236<br /><br /></div>

]]> http://cfcancerinst.com/2012/05/10/randomized-phase-3-study-comparing-standard-first-line-docetaxelprednisone-to-docetaxelprednisone-in-combination-with-custirsen-ogx-011-in-men-with-metastatic-castrate-resistant-prostate-cancer/feed/ 0 The BEACON Study (Breast Cancer Outcomes with NKTR-102): A Phase 3 Open Label, Randomized Multicneter Study of NKTR-102 Versus Treatmetn of Physicians Choice (TPC) in patients with Locally Recurrent or Metastatic Breast Cancer Previously treated With An Anthracycline, a Taxane, and Capecitabine Opening Soon http://cfcancerinst.com/2012/05/10/the-beacon-study-breast-cancer-outcomes-with-nktr-102-a-phase-3-open-label-randomized-multicneter-study-of-nktr-102-versus-treatmetn-of-physicians-choice-tpc-in-patients-with-locally-recurrent-o/ http://cfcancerinst.com/2012/05/10/the-beacon-study-breast-cancer-outcomes-with-nktr-102-a-phase-3-open-label-randomized-multicneter-study-of-nktr-102-versus-treatmetn-of-physicians-choice-tpc-in-patients-with-locally-recurrent-o/#comments Thu, 10 May 2012 16:23:06 +0000 http://cfcancerinst.cancercenter.cc/2012/05/10/the-beacon-study-breast-cancer-outcomes-with-nktr-102-a-phase-3-open-label-randomized-multicneter-study-of-nktr-102-versus-treatmetn-of-physicians-choice-tpc-in-patients-with-locally-recurrent-o/ <h4>Objective</h4><br /><h4>Overview</h4><br /><h4>Eligibility Requirements</h4>Inclusion:
1. Female with metastatic breast cancer
2. Measurable or evaluable disease
3. Prior therapy MUST INLCUDE- anthracycline (unless medical reason not to give), taxane and xeloda- treatments could be at any line of therapy, must have received minimum of two and a maximum of five prior cytotoxic regimens with last dose administered within 6 months of date of consent for this trial
4. HER2+ pts must have received herceptin and ER+ pts should have been treated with hormonal therapy
5. ECOG 0-1
6. Brain metastasis is allowed as long as treatment has occurred and use of corticosterioids for this indication discontinued for at least 3 weeks prior to randomization with stable brain mets by imaging and symptoms

Exclusion:
1. Chemotherapy within 21 days of randomization or hormonal therapy within 7 days
2. Radiation therapy within 2 weeks of randomization
3. Major surgery within 28 days
4. Received treatment for cancer with a camptothecin derivative (topotecan, irinotecan and other IP of same class)
5. Chronic or acute GI abnormalities
6. Require O2 on a dialy basis
7. Significant known cardiovascular impairment<h4>Contact Centers</h4><div id="clinic-26">The West Clinic<br />100 N Humphreys<br />Memphis<br />Tennessee<br />38120<br />Tracy B. Stewart, RN, BSN, OCN, CCRC<br />research@westclinic.com<br />901-683-0055 ext.1236<br /><br /></div>

]]> http://cfcancerinst.com/2012/05/10/the-beacon-study-breast-cancer-outcomes-with-nktr-102-a-phase-3-open-label-randomized-multicneter-study-of-nktr-102-versus-treatmetn-of-physicians-choice-tpc-in-patients-with-locally-recurrent-o/feed/ 0 A Randomized Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer Opening Soon http://cfcancerinst.com/2012/05/10/a-randomized-phase-2-study-of-the-efficacy-and-tolerability-of-veliparib-in-combination-with-temozolomide-or-veliparib-in-combination-with-carboplatin-and-paclitaxel-versus-placebo-plus-carboplatin-an/ http://cfcancerinst.com/2012/05/10/a-randomized-phase-2-study-of-the-efficacy-and-tolerability-of-veliparib-in-combination-with-temozolomide-or-veliparib-in-combination-with-carboplatin-and-paclitaxel-versus-placebo-plus-carboplatin-an/#comments Thu, 10 May 2012 16:21:43 +0000 http://cfcancerinst.cancercenter.cc/2012/05/10/a-randomized-phase-2-study-of-the-efficacy-and-tolerability-of-veliparib-in-combination-with-temozolomide-or-veliparib-in-combination-with-carboplatin-and-paclitaxel-versus-placebo-plus-carboplatin-an/ <h4>Objective</h4><br /><h4>Overview</h4><br /><h4>Eligibility Requirements</h4>1. Metastatic breast cancer with documented BRCA1 or BRCA2 mutaiton per Myriad labs- central testing can be done upon consent
2. HER2+ pts must have progressed on at least one prior standard HER2+ directed therapy or have a contraindication for this type of therapy
3. Measurable disease
4. ECOG 0-2

Exclusion:
1. Received therapy within 28 days
2. Palliative radiation therapy can occur at 14 days
3. More than one prior line of therapy for metastatic disease and if neo or adjuvant therapy within 6 months- that counts as one line of therapy
4. Prior therapy with Temozolomide, a platinum agent, a PARP inhibitor, a taxane in metastatic setting
5. History of or evidence of brain metastasis or leptomeningeal disease
6. History uncontrolled seizure disorder
7. Pre-existing neuropathy from any cause in excess of grade 1
8. Known history of allergic reactions to cremophor-paclitaxel
9. Clinically significant uncontrolled conditions per protocol
<h4>Contact Centers</h4><div id="clinic-26">The West Clinic<br />100 N Humphreys<br />Memphis<br />Tennessee<br />38120<br />Tracy B. Stewart, RN, BSN, OCN, CCRC<br />research@westclinic.com<br />901-683-0055 ext.1236<br /><br /></div>

]]> http://cfcancerinst.com/2012/05/10/a-randomized-phase-2-study-of-the-efficacy-and-tolerability-of-veliparib-in-combination-with-temozolomide-or-veliparib-in-combination-with-carboplatin-and-paclitaxel-versus-placebo-plus-carboplatin-an/feed/ 0 A Phase 2 Indication Identification Study of LY2523355 in Patients with Ovarian, Prostate, Gastroesophageal Cancers, and Squamous Cell Carcinoma of the Head and Neck http://cfcancerinst.com/2012/05/08/a-phase-2-indication-identification-study-of-ly2523355-in-patients-with-ovarian-prostate-gastroesophageal-cancers-and-squamous-cell-carcinoma-of-the-head-and-neck/ http://cfcancerinst.com/2012/05/08/a-phase-2-indication-identification-study-of-ly2523355-in-patients-with-ovarian-prostate-gastroesophageal-cancers-and-squamous-cell-carcinoma-of-the-head-and-neck/#comments Tue, 08 May 2012 17:03:54 +0000 http://cfcancerinst.cancercenter.cc/2012/05/08/a-phase-2-indication-identification-study-of-ly2523355-in-patients-with-ovarian-prostate-gastroesophageal-cancers-and-squamous-cell-carcinoma-of-the-head-and-neck/ <h4>Objective</h4><br /><h4>Overview</h4><br /><h4>Eligibility Requirements</h4>Inclusion:
1. Ovarian patients must be- platinum refractory or resistant which is failed therapy within 6 months after response
a. Received one but no more than 2 prior platinum-based regimens and at least one regimen must have included a Taxane
2. Non Small Cell Lung Cancer patients must-at leat one but no more than 2 regimens including one platinum based regimen
3. Prostate patients must- received no more than 2 prior systemic regimens and one must have contained Docetaxel
a. Testosterone level < 50
4. Squamous cell Head and Neck patient must- received at least one but no more than 2 prior chemotherapy regimens
5. ALL above cancer types must ALL-
a. Measureable disease
b. ECOG 0-1
c. Adequate organ function
Exclusion:
1. Serious pre-existing conditions that would preclude participation in this study
2. Symptomatic, untreated or uncontrolled CNS mets- if treated may be eligible if stable, asymptomatic and off steroids for at least 2 weeks
3. QTc interval > 470
4. Previous treatment with LY2523355
<h4>Contact Centers</h4><div id="clinic-26">The West Clinic<br />100 N Humphreys<br />Memphis<br />Tennessee<br />38120<br />Tracy B. Stewart, RN, BSN, OCN, CCRC<br />research@westclinic.com<br />901-683-0055 ext.1236<br /><br /></div>

]]> http://cfcancerinst.com/2012/05/08/a-phase-2-indication-identification-study-of-ly2523355-in-patients-with-ovarian-prostate-gastroesophageal-cancers-and-squamous-cell-carcinoma-of-the-head-and-neck/feed/ 0 A Phase I, Open-Label, Mulit-Center Dose Escalation Study of Oral BGJ398, a Pan FGF-R Kinase Inhibitor, In Adult Patients with Advanced Solid Tumors http://cfcancerinst.com/2012/05/08/a-phase-i-open-label-mulit-center-dose-escalation-study-of-oral-bgj398-a-pan-fgf-r-kinase-inhibitor-in-adult-patients-with-advanced-solid-tumors/ http://cfcancerinst.com/2012/05/08/a-phase-i-open-label-mulit-center-dose-escalation-study-of-oral-bgj398-a-pan-fgf-r-kinase-inhibitor-in-adult-patients-with-advanced-solid-tumors/#comments Tue, 08 May 2012 17:02:33 +0000 http://cfcancerinst.cancercenter.cc/2012/05/08/a-phase-i-open-label-mulit-center-dose-escalation-study-of-oral-bgj398-a-pan-fgf-r-kinase-inhibitor-in-adult-patients-with-advanced-solid-tumors/ <h4>Objective</h4><br /><h4>Overview</h4><br /><h4>Eligibility Requirements</h4>Inclusion:
1. Refractory to all standard of care therapies
2. FGFR mutation only- central testing required
3. Advanced solid tumor (squamous lung, breast, gastric)
4. ECOG 0-2
5. Adequate organ function
6. Normal serum inorganic phosphorus and normalserum total and ionized calcium
7. Adequate cardiac function
Exclusion:
1. Prior treatment with FGFR inhibitor or MEK inhibitor with the exception of TKI 258
2. Primary CNS metastasis or CNS metastasis secondary to other cancers- UNLESS clinically stable > one month
3. History and/or current evidence of endocrine alteration-parathyroid disorders
4. History of parathyroidectomy
5. Tumor lysis
6. Tumorial calcinosis
7. Current evidence of corneal disorder/keratopathy, corneal abrasion, inflammation/ulceration, kertoconjunctivitis
8. Active or unstable cardio/cerebrovascular disease
9. History of MI/ACS, CABG, symptomatic CHF, CVA
10. Symptomatic PAD/PVD
11. CXR or CT scan of chest with evidence of lung calcifications <h4>Contact Centers</h4><div id="clinic-26">The West Clinic<br />100 N Humphreys<br />Memphis<br />Tennessee<br />38120<br />Tracy B. Stewart, RN, BSN, OCN, CCRC<br />research@westclinic.com<br />901-683-0055 ext.1236<br /><br /></div>

]]> http://cfcancerinst.com/2012/05/08/a-phase-i-open-label-mulit-center-dose-escalation-study-of-oral-bgj398-a-pan-fgf-r-kinase-inhibitor-in-adult-patients-with-advanced-solid-tumors/feed/ 0 Vaginal DHEA for Vaginal Symptoms: A Phase III Randomized, Double Blind, Placebo-Controlled Trial http://cfcancerinst.com/2012/05/04/vaginal-dhea-for-vaginal-symptoms-a-phase-iii-randomized-double-blind-placebo-controlled-trial/ http://cfcancerinst.com/2012/05/04/vaginal-dhea-for-vaginal-symptoms-a-phase-iii-randomized-double-blind-placebo-controlled-trial/#comments Fri, 04 May 2012 09:22:27 +0000 http://cfcancerinst.cancercenter.cc/2012/05/04/vaginal-dhea-for-vaginal-symptoms-a-phase-iii-randomized-double-blind-placebo-controlled-trial/ <h4>Objective</h4><br /><h4>Overview</h4><br /><h4>Eligibility Requirements</h4><h4>Contact Centers</h4><div id="clinic-47">University of New Mexico<br />1201 Camino de Salud NE, MSC07-4025<br />Albuquerque<br />New Mexico<br />87131<br />Valerie Parks, RN<br />ClinicalTrialInfo@salud.unm.edu<br />505-925-0390<br /><br /></div>

]]> http://cfcancerinst.com/2012/05/04/vaginal-dhea-for-vaginal-symptoms-a-phase-iii-randomized-double-blind-placebo-controlled-trial/feed/ 0 A Randomized Placebo-Controlled Trial of Omega-3-Fatty Acid for the Control of Aromatase Inhibitor-Induced Musculoskeletal Pain and Stiffness in Women with Early Stage Breast Cancer, Phase III http://cfcancerinst.com/2012/05/04/a-randomized-placebo-controlled-trial-of-omega-3-fatty-acid-for-the-control-of-aromatase-inhibitor-induced-musculoskeletal-pain-and-stiffness-in-women-with-early-stage-breast-cancer-phase-iii/ http://cfcancerinst.com/2012/05/04/a-randomized-placebo-controlled-trial-of-omega-3-fatty-acid-for-the-control-of-aromatase-inhibitor-induced-musculoskeletal-pain-and-stiffness-in-women-with-early-stage-breast-cancer-phase-iii/#comments Fri, 04 May 2012 09:21:52 +0000 http://cfcancerinst.cancercenter.cc/2012/05/04/a-randomized-placebo-controlled-trial-of-omega-3-fatty-acid-for-the-control-of-aromatase-inhibitor-induced-musculoskeletal-pain-and-stiffness-in-women-with-early-stage-breast-cancer-phase-iii/ <h4>Objective</h4><br /><h4>Overview</h4><br /><h4>Eligibility Requirements</h4><h4>Contact Centers</h4><div id="clinic-47">University of New Mexico<br />1201 Camino de Salud NE, MSC07-4025<br />Albuquerque<br />New Mexico<br />87131<br />Valerie Parks, RN<br />ClinicalTrialInfo@salud.unm.edu<br />505-925-0390<br /><br /></div>

]]> http://cfcancerinst.com/2012/05/04/a-randomized-placebo-controlled-trial-of-omega-3-fatty-acid-for-the-control-of-aromatase-inhibitor-induced-musculoskeletal-pain-and-stiffness-in-women-with-early-stage-breast-cancer-phase-iii/feed/ 0 NewLink Genetics NLG-0405: A Phase III Study of Chemotherapy and Chemoradiotherapy with or without HyperAcute-Pancreas (algenpantucel-L) Immunotherapy in Subjects with Surgically Resected Pancreatic Cancer http://cfcancerinst.com/2012/04/20/newlink-genetics-nlg-0405-a-phase-iii-study-of-chemotherapy-and-chemoradiotherapy-with-or-without-hyperacute-pancreas-algenpantucel-l-immunotherapy-in-subjects-with-surgically-resected-pancreatic-c/ http://cfcancerinst.com/2012/04/20/newlink-genetics-nlg-0405-a-phase-iii-study-of-chemotherapy-and-chemoradiotherapy-with-or-without-hyperacute-pancreas-algenpantucel-l-immunotherapy-in-subjects-with-surgically-resected-pancreatic-c/#comments Fri, 20 Apr 2012 09:48:29 +0000 http://cfcancerinst.cancercenter.cc/2012/04/20/newlink-genetics-nlg-0405-a-phase-iii-study-of-chemotherapy-and-chemoradiotherapy-with-or-without-hyperacute-pancreas-algenpantucel-l-immunotherapy-in-subjects-with-surgically-resected-pancreatic-c/ <h4>Objective</h4><br /><h4>Overview</h4><br /><h4>Eligibility Requirements</h4><h4>Contact Centers</h4><div id="clinic-47">University of New Mexico<br />1201 Camino de Salud NE, MSC07-4025<br />Albuquerque<br />New Mexico<br />87131<br />Valerie Parks, RN<br />ClinicalTrialInfo@salud.unm.edu<br />505-925-0390<br /><br /></div>

]]> http://cfcancerinst.com/2012/04/20/newlink-genetics-nlg-0405-a-phase-iii-study-of-chemotherapy-and-chemoradiotherapy-with-or-without-hyperacute-pancreas-algenpantucel-l-immunotherapy-in-subjects-with-surgically-resected-pancreatic-c/feed/ 0