Trinity Medical Center Cancer Treatment Protocols

BREAST

BREAST – ADJUVANT
Protocol / Description
NSABP B-43 / A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma in Situ Resected by Lumpectomy
S1007 / A Phase III Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less
S1207 / Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer
BREAST – ADVANCED
Protocol / Description
E2108 / A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

GASTROINTESTINAL (GI)

GI – ADJUVANT COLORECTAL
Protocol / Description
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
GI – ADVANCED COLORECTAL
Protocol / Description
E7208 / A Randomized Phase II Study of Irinotecan and Cetuximab with or without the Anti-Angiogenic Antibody, Ramucirumab, in Advanced, K-ras Wild-type Colorectal Cancer following Progression on Bevacizumab-Containing Chemotherapy
***TEMPORARILY SUSPENDED, 6/14/12***
N1048 / A Phase II/III Trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation vs Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision
OTHER GI
Protocol / Description
CALGB 80803 / Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer
***PENDING***
E2211 / A Randomized Phase II Study of Temozolomide or Temozolomide and Capecitabine in Patients with Advanced Neuroendocrine Tumors
RTOG 1010 / A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma
***PENDING***
S1201 / A Randomized Phase II Pilot Study Prospectively Evaluating Treatment for Patients Based on ERCC1 (Excision Repair Cross-Complementing 1) for Advanced / Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer

GENITO-URINARY (GU)

Protocol / Description
A031203 / Randomized Phase II Study Comparing Cabozantinib with Commercially-Supplied Sunitinib in Patients with Previously Untreated Locally Advanced or Metastatic Renal Cell Carcinoma
RTOG 0534 / A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients with a Rising PSA After Radical Prostatectomy
S1216 / A 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

GYNECOLOGIC

Protocol / Description
GOG 0238 / 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 AND NECK

Protocol / Description
E1305 / A Phase III Randomized Trial of Chemotherapy with or without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer
E1311 / A Randomized, Placebo-Controlled Phase II Trial of Afatinib as Adjuvant Therapy Following Chemoradiation in Patients with Head and Neck Squamous Cell Carcinoma at High Risk of Recurrence

HEMATOLOGIC

Protocol / Description
E1412 / Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly-Diagnosed Diffuse Large B Cell Lymphoma
***PENDING***
E1A11 / Randomized Phase II Trial of Bortezomib, Lenalidomide and Dexamethasone (VRd) vs Carfilzomib, Lenalidomide and Dexamethasone (CRd) followed by Limited or Indefinite Duration Lenalidomide Maintenance in Patients with Newly-Diagnosed Symptomatic Multiple Myeloma
***PENDING***
S1117 / A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide vs Azacitidine Alone vs Azacitidine in Combination with Vorinostat for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CLL)
***TEMPORARILY CLOSED, 4/15/14***
S1211 / A Randomized Phase I/II Study of Optimal Induction
***PENDING***

LUNG

SMALL CELL LUNG
Protocol / Description
CALGB 30610 / Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide
E2511 / Phase I and Randomized Phase II Double-Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib (ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer
***PHASE II PENDING***
NON-SMALL CELL LUNG
Protocol / Description
E6508 / A Phase II Study of L-BLP25 and Bevacizumab in Unresectable Stage IIIA and IIIB Non-Squamous Non-Small Cell Lung Cancer after Definitive Chemoradiation
S0819 / A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer
***TEMPORARILY CLOSED, 6/1/14***

MELANOMA

Protocol / Description
A091201 / Randomized Phase II Study Comparing the MET Inhibitor Cabozantinib to Temozolomide / Dacarbazine in Ocular Melanoma
E1609 / A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 Therapy vs High-Dose Interferon Alfa-2b for Resected High-risk Melanoma
E2607 / Phase II Trial of Dasatinib in Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Solar Melanomas
E3611 / A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Combination with High Dose Interferon-α in Advanced Melanoma
E3612 / A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma

SARCOMA

Protocol / Description
A091102 / Phase II Study of MLN8237 in Advanced / Metastatic Sarcoma

SYMPTOMS CONTROL

Protocol / Description
A221101 / The Use of Armodafinil (Nuvigil®) to Reduce Cancer-Related Fatigue in Patients with Glioblastoma Multiforme: A Randomized, Novel Adaptive Design Study
A221102 / Randomized Double-Blind Placebo-Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women with Aromatase Inhibitor-Induced Arthralgias