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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

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

B-52 (NSABP-CTSU)

Hormone receptor+, HER2+

A Randomized Phase III Trial Evaluating Pathologic Complete Response Rates in Patients with Hormone Receptor-Positive, HER2-Positive, Large Operable and Locally Advanced Breast Cancer Treated with Neoadjuvant Therapy of Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab (TCHP) With or Without Estrogen Deprivation

A011202 (Alliance)

Positive SLN(s) after completion of neoadjuvant chemo

A Randomized Phase III Trial Evaluating  the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (CT1-3 N1) Who Have Positive Sentienl Lymph Node Disease After Neoadjuvant Chemotherapy

Breast- Adjuvant

BRE 186 (SCRI)

No complete Response (pCR) post neo-adj tx

Phase II 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

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
 

B-51 (NSABP-CTSU)

Neg. Axillary Nodes after Neoadjuvant chemo
 

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest Wall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

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
 

BRE 203 (SCRI)

Metastatic, AR+

A Phase II Study with Orteronel as Monotherapy in Patients with Metastatic Breast Cancer (MBC) that Expresses the Androgen Receptor (AR)

 E2108 (ECOG-CTSU)

Intact Primary tumor and metastic

A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

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

CALGB 80702

A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer

Colorectal    – Adv / Metastatic
 

Colorectal - Prevention

S0820(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 (SCRI) 

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)

0724 (RTOG)

Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With or Without Adjuvant Chemotherapy in High-Risk Patients With  Early-Stage Cervical Carcinoma Following Radical Hysterectomy

0263 (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

0258 (GOG)

Debulked, Advanced

A Randomized Phase III TrialL of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel Vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma

0286B (GOG)

Stage III or IV

A Randomized Phase II/III Study of Paclitaxel//Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer

 

Ovarian / Fallopian Tube / Peritoneal


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

3004 (GOG)

Germline BRCA Mutation; Stage III-IV; CR or PR post 1st line platinum tx

Ph III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Pts with a germline BRCA mutation & Stage III-IV Ovarian Cancer who are in Complete or Partial Response Following 1st Line Platinum Based Chemotherapy

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

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

 

0225 ( GOG)

Lifestyle and Counseling


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

0273 (GOG)

Lifestyle

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

0283 (GOG)

Clear Cell Carcinoma Characterized for the Retention or Loss of BAF250a Expression

A Phase II Trial of DCTD-Sponsored Dasatinib (NSC #732517 IND #120636) In Recurrent/Persistent Ovary, Fallopian Tube, Primary Peritoneal, and Endometrial  Clear Cell Carcinoma Characterized for the Retention or Loss of BAF250a Expression

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
 

0277 (GOG)
 

High-Grade Uterine Leiomyosarcoma

A Phase III Randomized Trial of Gemcitabine (NSC # 613327) plus Docetaxel (NSC # 628503) followed by Doxorubicin (NSC # 123127) versus Observation for Uterus-Limited, High-Grade Uterine Leiomyosarcoma

HEAD & NECK

E1305 (ECOG)

1st line Metastatic / 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


LUNG

Lung- Neoadjuvant

Lung- Adjuvant

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
 

1306 (RTOG)

Unresectable IIIA/B N2/N3 non-squamous NSCLC

A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-small Cell Lung Cancer (NSCLC)

Control Study for Lung


  No studies

 

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

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

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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