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Current Clinical Trials

The Cancer Center is currently offering the following trials:

BLADDER

CALGB 90601 (CTSU)

1st line Met/Adv

Ph III Randomized Double-blinded - Comparing Gemcitabine, Cisplatin & Bevacizumab to Gemcitabine, Cisplatin &Placebo in Pts w/Adv Transitional Cell Carcinoma 

BRAIN

0929 (RTOG)

Recurrent GBM

A Randomized Phase I/II Study of ABT-888 in Combination with Temozolomide in Recurrent (Temozolomide Resistant) Glioblastoma

N0574 (CTSU)

Stereotactic vs. WBRT; 1-3 Cerebral Metastatis

Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients with One to Three Cerebral Metastases

1122  (RTOG)

Recurrent Glioblastoma or Gliosarcoma

Ph II Double-Blinded Placebo - Controlled Study of Bevacizumab with or without AMG 386 in Patients with Recurrent Glioblastoma or Gliosarcoma

1119 (RTOG)

 Brain Metastasis for  HER2 Breast Positive Breast Cancer

Phase II Randomized Study Of Whole Brain Radiotherapy In Combination With Concurrent Lapatinib In Patients With Brain Metastasis From HER2-Positive Breast Cancer A Collaborative Study Of RTOG and KROG

A221101(Alliance)

Glioblastoma

The Use of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with Glioblastoma Multiform:  A Randomized, Novel Adaptive Design Study

 
BREAST 

Breast - Neoadjuvant

NBRST - (Free Testing) Gene Profiling
Tissue collected: core needle or incisional bx.Can submit block or unstained slides. or fresh tissue. Potential Patient for Neoadjuvant Treatment.

Prospective; NeoadjuvantBreast Registry Trial linking MammPrint, Subtyping & TX Response

Patient started or scheduled to start neo-adjuvant chemotherapy therapy or neo-adjuvant hormone therapy, after successful MammaPrint assay. NO distant mets.
                                          ______________________________________

PROMIS- (Free Testing) 
Invasive Breaset Cancer, Stage I-II with  Resulting Oncotype DX Intermediate Score (18-30)

Prospective Registry of MammaPrint Breast Cancer Patients with an Intermedicate Recurrence Score

BRE 197 (SCRI)

Baseline tumor samples collected from all patients (if available); HER2-Neg;  Locally Advanced

Randomized, Phase II Study of Eribulin / Cyclophosphamide or Docetaxel / Cyclophosphamide as Neoadjuvant Therapy in Locally Advanced HER2- Negative Breast Cancer
 

Breast- Adjuvant

BRE 186 (SCRI)

NO Pathologic Response Post Neoadjuvant Treatment

Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy

B-43 (NSABP-CTSU)

1st line DCIS HER2 Positive- Lumpectomy

Ph III, Comparing Trastuzumab Concurrent w/XRT & XRT Alone in Women w/ Her2-Positive DCIS Resected by Lumpectomy

S1007 (SWOG)

1-2 Positive Nodes, Hormone Receptor Positive / Her2 Negative, Recurrent Breast Score (RS) <  25

Ph III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and Her2-Negative Breast Cancer with Recurrence Score (Rs) of 25 or Less

B- 49 (NSABP-CTSU)

Node-Positive Or High-Risk Node-Negative, Her2-Negative

A Phase III Clinical Trial Comparing The Combination Of Docetaxel Plus Cyclophosphamide To Anthracycline-Based Chemotherapy Regimens For Women With Node-Positive Or High-Risk Node-Negative, Her2-Negative Breast Cancer

S1207(SWOG)

High-risk, hormone receptor+, HER2-

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of EVEROLIMUS in Patients with High-Risk, Hormone Receptor-Positive AND HER2/neu Negative Breast Cancer

Breast - Adv / Metastatic

1119 (RTOG)

Brain Metastasis for  HER2 Breast Positive Breast Cancer

Phase II Randomized Study Of Whole Brain Radiotherapy In Combination With Concurrent Lapatinib In Patients With Brain Metastasis From HER2-Positive Breast Cancer A Collaborative Study Of RTOG and KROG


Breast - Control Study


SCUSF 0806 (CTSU)

Prevention Trial: Reduction Of Cardiotoxicity

Phase II placebo-controlled trial of lisinopril and Coreg CR® to reduce cardiotoxicity in patients with breast cancer receiving (neo)adjuvant chemotherapy with trastuzumab (Herceptin®)

COLORECTAL

Colorectal - Adjuvant

No Studies

Colorectal    – Adv / Metastatic

GI 154 (SCRI)

1st Line, Adenocarcinoma, Requires Measurable Disease

Trial of Single Agent Axitimib as Maintenance Therapy for Patients with 1st Line Metastatic Colorectal Cancer (mCRC)

GI 134 (SCRI)

Colon / Rectum Stage IV Metastatic liver-only disease

Ph II Study of Folfoxiri Plus Paitumumab Followed by Evaluation for Resection, in Patients with Metastatic KRAS Wild-Type Colorectal Cancer with Liver Metastases Only
 

Colorectal - Prevention

S8028(SWOG)

Stage O-III Colon Cancer

A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon Cancer, Phase III - Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)

API-CP001 (Applied Proteomics)

Scheduled for both screening and diagnostic colonoscopies

Colorectal Cancer Biomarker Specimen Collection Study

GI

1010 (RTOG)

HER-2 Over-expressing Esophageal

A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma
 
GI 166

HER-2 positive  Esophagogastic Adenocarcinoma

A Phase II Study with Lead-in Safety Cohortof 5-Fluorouracil, Oxaliplatin and Lapatinib in Combination with Radiation Therapy as Neoadjuvant Treatment for Patients with Localized HER2 Positive Esophagogastric Adenocarcinomas
 

GYN (GOG Studies)

CERVICAL /ENDOMETRIAL


1203 (RTOG)

Pathologically proven diagnosis; post operative radiation or chemoradiation

A Randomized Phase III Study of Standard VS. IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer (TIME-C)

0236 (GOG)

Stage I/IIA

Randomized Phase III Clinical Trial of Adjuvant  Radiation Versus Chemoradiation in Intermdiate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and  Pelvic Lymphadenectomy

0274 (GOG) OUTBACK

Locally Advanced

A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone

Ovarian / Fallopian Tube / Peritoneal

0186I (GOG)

Recurrent or Persistent

Randomized,  Ph II, Evaluation of Single-Agent Bevacizumab and Combination Bevacizumab With Fosbretabulin Tromethamine (Ca4p) in The Treatment Of Recurrent Or Persistent Epithelial Ovarian,Fallopian Tube Or Primary Peritoneal Carcinoma

0186J (GOG)

Recurrent or Persistent


A Randomized Phase IIB Evaluation Of Weekly Paclitaxel (NSC #673089) Plus Pazopanib (NSC #737754) Versus Weekly Paclitaxel Plus Placebo In The Treatment Of Persistent Or Recurrent Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Carcinoma

0186k(GOG)

Recurrent or Persistent

A Randomized phase II study of NCI SUPPLIED cabozantinib (NSC #761968 IND #116059) versus weekly paclitaxel (NSC #673089) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer

3003(GOG)

Recurrent or Persistent

A Randomized, Double-Blind, Placebo-Controlled Phase Ii Study Of Vtx 2337 In Combination With Pegylated Liposomal Doxorubicin (Pld) In Patients With Recurrent Or Persistent Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Cancer


0212 (GOG)

Maintenance Chemotherapy

Ph. III, Maintenance Chemo Comparing 12 Monthly Cycles of Single Agent Paclitaxel Or CT-2103 Vs. No Tx Until Documented Relapse in Women W/ Adv. Ovarian Or Primary Peritoneal Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy on & TX of Cancer

0213 (GOG)

2nd line

Ph III, Randomized, Controlled; Carboplatin & Paclitaxel Alone or in Combo W/ Bevacizumab Followed by Bevacizumab & Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary & Fallopian Tube Cancer

0241 (GOG)

Newly Diagnosed Stage II,III,IV or Recurrent Stage I Epithelial Ovarian Or Fallopian Cancer

GCIG Intergroup Multicenter Ph III Trial Of Open Label Carboplatin And Paclitaxel +/- NCI-Supplied Agent: Bevacizumab Compared With Oxaliplatin And Capecitabine +/- Bevacizumab As First Line Chemotherapy In Patients With Mucinous Epithelial Ovarian Or Fallopian Tube Cancer (Meoc)

0225 ( GOG)

Lifestyle and Counseling

Can Diet and Physicial Activity Modulate Ovarian, Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival

EC-FV-06 PROCEED (Endocyte)

Plantinum Resistent Ovarian Cancer

A Randomized Double-Blind Phase III Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (Pld/Doxil/Caelyx) in Combination versus Pld in Participants with Platinum-Resistant Ovarian Cancer

0273 (GOG)

Lifestyle

Chemotherapy Toxicity in Elderly Women with Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Uterus

0131H (GOG)

Recurrent or Persistent Leiomysarcoma of the Uterus

Phase II, Evaluation of Ixabepilone (IND # 59699) nin the Treatment of Recurrent or Persistent Leiomyoscarcoma of the Uterus

0275 (GOG)

Low-Risk Gestational Trohoblastic Neoplasia

Ph III, Randomized Trial of Pulse Actinomycin-D vs Multi-Day Methotrexate for the Treatment of Low Risk Gestational Trophoblastic Neoplasia

0238(GOG)

Recurrence of Carcinoma of the Uterine Corpus

A Randomized Trial Of Pelvic Irradiation With Or Without Concurrent Weekly Cisplatin In Patients With Pelvic-Only Recurrence Of Carcinoma Of The Uterine Corpus


HEAD & NECK

E1305 (ECOG- CTSU)

1st line Metastatic / Recurrent; Adv Dz

Ph III, Randomized Trial of Chemotherapy w/wo Bevacizumab in Pts w/ Recurrent or Metastatic HN Cancer

0920 (RTOG)

Locally Advanced Resected H/N Cancer

A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally Advanced Resected Head and Neck Cancer

1016 (RTOG)

Oralpharyngeal Cancer

Radiation Therapy with Cisplatin or Cetuximab in Treating Patients with Oralpharyngeal Cancer


LUNG

Lung- Neoadjuvant

LUN186(SCRI)

1st Line

Ph II, Preop Pemetrexed and Carboplatin in Pts W/Select Stage IB, II, and III Non-Squamous NSCLC
 

Lung- Adjuvant

E1505 (ECOG-CTSU)

1st Line- Completely Resected; includes Squamous

Ph III, Randomized Adjuvant Chemo W/WO Bevacizumab For Pts W/ Completely Resected Stage 1B (> 4 Cm) – IIIA (> 6 wks- < 12 wks post op) (Temporary Suspension- pre-Menopausal Women 12-19-2011)

Lung- Adv / Metastatic

CALGB 30610 (RTOG 0538-CTSU)

1st line; Limited SCLC

Ph III, Comparison of Thoracic Radiotherapy Regimens in Pts W/Limited SCLC Also Receiving Cisplatin and Etoposide

E 5508 (ECOG-CTSU)

Advanced Non-Squamous

Randomized Ph III Study of Maintenance Therapy with Bevacizumab,    Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC


S0905 (SWOG)

1st Line Malignant Pleural Mesothelioma

Ph II, Randomized Study of Cediranib vs. Placebo in Combination with Cisplatin and Pemetrexed in Chemonaive Patients with Malignant Pleural Mesothelioma

LUN 196 (SCRI) –TOPPS

1st line; Poor PS (2);  Unresectable

Randomized Ph III, Pemetrexed / Bevacizumab vs. Pemetrexed / Carboplatin / Bevacizumab Pts w/ Stage IIIB / IV NSCLC & PS 2

30801 (CALGB CTSU)  

Selective COX-2 Inhibition in COX-2 Expressing NSCLC

A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition In COX-2 Expressing Advanced Non-Small Cell Lung Cancer

Control Study for Lung

 1012 (RTOG)

Pain Induced Esophagitis - SC or NSCLC: Minimum 5 cm tumor within 60 Gy Isodose Volume

PhII, Randomized Trial of Prophylactic Manuka Honey for Reduction of Chemoradiation Therapy Induced Esophagitis -Related Pain During the Treatment of Lung Cancer -


LYMPHOMA
 
No Studies

MELANOMA

No Studies

PANCREAS

0848 (RTOG)

1st line; Post Curative Surgery

A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma
 
S1115 (SWOG)

Metastatic Pancreatic Cancer After Prior Chemotherapy

Randomized Phase II Clinical Trial of AZD6244 Hydrogen Sulfate (NSC-748727) and MK-2206 (NSC-749607) VS mFOLFOX in Patients with Metastatic Pancreatic Cancer After Prior Chemotherapy

 

PROSTATE- NeoAdjuvant

Procede-1000

Newly Diagnosed Prostate Cance - Tissue collection   

An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients 

PROSTATE- Adjuvant

0924 (RTOG)

Androgen TX ; Plus Hi-Dose XRT; HI-Risk

Androgen Deprivation Therapy And High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy In Unfavorable Intermediate Or Favorable High Risk Prostate Cancer:  Ph III Randomized Trial

0815 (RTOG)

Node (-); < 6 mos of Dx

Ph III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer

0534 (RTOG)

Adjuvant; Node (-); Rising PSA After Surgery

Ph III, Short Term Androgen Deprivation W/Pelvic LN or Prostate Bed Only Radiotherapy (Sport) in Prostate Cancer Pts W/ a Rising PSA After Radical Prostatectomy
 

Prostate-Adv / Metastatic

S1216(SWOG)

Androgen Deprivation Therapy

Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 with Androgen Deprivation Therapy + Bicalutamide in Patients with Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer


RENAL CELL

Renal Cell - Adv / Metastatic

GU 75 (CHORUS)(SCRI- Lilly)

Metastatic Renal Cell

Randomized, Multicenter, Open-Label, Active Controlled, Ph 2 Study of LY2510924 &  Sunitinib vs Sunitinib in Pts w/ MRCC

E2810 (ECOG- CTSU)

Post Matastatectomy - NO Evidence of Disease

Randomized, Double-Blinded, Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Hane No Evidence of Disease Oloopwing a Mastatectomy

MISCELLANEOUS

S0702 (SWOG) 

Assessment of Osteonecrosis of the Jaw Receiving Zoledronic Acid Treatment

A Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zolendronic Acid Treatment

E1609 (ECOG)

High Risk Melanoma

A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon a-2b for Resected High-Risk Melanoma


 

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