Sharon Bell, RN
Clinical Trials Nurse
252-975-4308 ext. 104
Email: sbell@brhealthsystem.org
BREAST
SWOG S107
A Phase 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.
Principle Investigator: Jennie R. Crews, MD
NSABP B47
A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of TC or Four Cycles of AC Followed by Four Cycles of Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node-Negative HER2-Normal Invasive Breast Principle Investigator: Jennie R. Crews, MD
CALGB 40502:
A Randomized Phase Iii Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound Nab-Paclitaxel or Ixabepilone Combined with Bevacizumab as First -Line Therapy for Locally Recurrent or Metastatic Breast Cancer.
Principal Investigator: Jennie R. Crews, MD
Eli Lilly/IMCL CP20-0903
An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Ramucirumab (IMC-1121B) Drug Product or IMC-18F1 in Combination with Capecitabine or Capecitabine Monotherapy, in Locally-Advanced Unresectable, or Metastatic Breast Cancer Patients Previously Treated with Anthracycline and Taxane Therapy.
Principle Investigator: Jennie R. Crews, MD
Genentech TDM4370g
A Randomized, Multicenter, Phase III Open-Label Study of the Efficacy and Safety of Trastuzumab-MCC-DMI versus Capecitabine + Lapatinib in Patients with Her2 Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy
Principal Investigator – Jennie Crews, MD
GlaxoSmithKline LPT112515:
A Randomized, Open-label Study of Lapatinib plus Trastuzumab versus Trastuzumab as Continued HER2 Suppression Therapy after Completion of First- or Second-line Trastuzumab plus Chemotherapy in Subjects with HER2 positive Metastatic Breast Cancer.
Principal Investigator – Jennie Crews, MD
CALGB 40601:
A randomized phase III trial of paclitaxel combined with trastuzumab, lapatinib, or both as neoadjuvant treatment of HER2 positive primary breast cancer.
Principal Investigator – Jennie Crews, MD
Novartis ZACT-1:
A multicenter and phase IV, open-label, randomized trial to evaluate the anti-cancer effects of zoledronic acid using circulating tumor cell measurements in patients with newly diagnosed HER2-negative metastatic breast cancer
Principal Investigator: Jennie R. Crews, MD
Roche/Gne B022589:
A randomized, 3-arm, multicenter, phase III study to evaluate the efficacy and the safety of T-DM1 combined with Pertuzamab or T-DM1 combined with Pertuzumab-Placebo, versus the combination of Herceptin plus taxane, as 1st-line treatment in HER2+ progressive or recurrent locally advanced or metastatic breast cancer.
Principal Investigator: Jennie R. Crews, MD
LYMPHOMA
LCCC 1011 (UNC/Lineberger Cancer Center)
Phase II Trial of Bendamustine in Combination with Rituximab in Older Patients with Previously Untreated Diffuse Large B-cell Lymphoma.
LUNG
Amgen 20070782 Aranesp
A Randomized, Double-blind, placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500mcg Once-Every-3-Weeks in anemic subjects with advanced stage (wet IIIB) NSCLC receiving multi-cycle chemotherapy
Principal Investigator – John Inzerillo, MD
CALGB 30704:
A Randomized Phase II Study to Assess the Efficacy of Pemetrexed or Sunitinib (NSC #736511, IND #74019) or Pemetrexed Plus Sunitinib in the Second-Line Treatment of Advanced Non-Small Cell Lung Cancer
Principal Investigator – John Inzerillo, MD
GASTROINTESTIONAL
LCCC 0918-COLON (UNC/LINEBERGER CANCER CENTER)
A Multicenter Study Investigating Utilization of Pharmacokinetic-Guided 5-Flourouracil in Patients Receiving FOLFOX6 With or Without Bevacizumab.
Principal Investigator – John Inzerillo, MD
CALGB 80405:
A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5FU/ Leucovorin with Bevacizumab or Cetuximab (C225) for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum.
Principal Investigator: Jennie R. Crews, MD
AGICC-09CRC02:
A dose finding and phase II study of AZD6244 (Hyd-Sulfate) in combination with irinotecan in 2nd line patients with K-Ras or B-Raf mutation positive advanced or metastatic colorectal cancer.
Principal Investigator: John J. Inzeriollo, MD
CALGB 80702
A phase II trial of 6 versus 12 treatmetns of adjuvant FOLFOX plus Celecoxib or placebo for patients with resected stage III colon cancer.
Principal Investigator: John J. Inzerillo, MD
LCCC 1029
An open label, multi-center, randomized phase II study of regorafenib in combination with FOLFIRI versus FOLFIRI alone as second line therapy in patients with metastatic colorectal cancer Principal Investigator: John J. Inzerillo, MD
REGISTRY/OBSERVATIONAL
Caris Diagnostics TCREG-001-00-V2-1209
A Registry of the Target Now® Test Results (Biomarker Expression Patterns) For Evaluation of Correlation with Clinical Outcomes for Cancer Patients.
Principal Investigator—Jennie R. Crews, MD
LCCC 0916 (UNC/Lineberger Cancer Center):
Carolina Senior: UNC Registry for Older Cancer Patients.
Principal Investigator: John J. Inzerillo, MD
GENITOURINARY
Sanofi-Aventis EFC11784
A randomized, open label, multi-center study comparing cabazitaxel at 25 mg/m2 and at 20 mg/m2 in combination with Prednisone every 3 weeks to docetaxel in combination with Prednisone in patients with hormone refractory metastatic prostate cancer not pretreated with chemotherapy.
Principal Investigator: John J. Inzerillo, MD
RTOG 0232
A phase III study comparing combined external beam radiation and tansperineal interstitial permanent brachytherapy with brachytherapy alone for selected patients with intermediate risk prostate carcinoma.
Principal Investigator: John J. Inzerillo, MD
CALGB 90802
Randomized Phase III Trial Comparing Everolimus Plus Placebo versus Everolimus Plus Bevacizumab for Advanced Renal Cell Carcinoma Progressing After Treatment with Tyrosine Kinase Inhibitors
Principal Investigator: John J. Inzerillo, MD
For general information about clinical trials visit www.cancer.gov/clinicaltrials/
