The NCCN ORP has received millions of dollars in research grants from major pharmaceutical companies to support investigator-initiated trials, which explore new venues of clinical investigation that answer important scientific questions. Studies evaluate innovative combinations and sequencing regimens of drugs, mechanisms of action of specific agents, or drug resistance or are directed toward exploring extended uses for specific agents. NCCN has received the following grants to support investigator-initiated trials:
Clinical Studies for Irinotecan
Clinical Studies for Celecoxib
Clinical Studies for Capecitabine
Preclinical Studies for Sunitinib
Specialized Imaging Studies for Sunitinib
Clinical Studies for Abraxane®
Clinical Studies for Cetuximab
Clinical Studies for Bendamustine
Clinical Studies for Vorinostat
Clinical Studies for Temsirolimus
Clinical Studies for Irinotecan
INVESTIGATOR |
MEMBER INSTITUTION |
STUDY |
Patrick J. Creaven, MD, PhD |
Roswell Park Cancer Institute |
Phase I Study of Irinotecan followed by Capecitabine in Patients with Advanced Breast Carcinoma |
Stacy Moulder, MD |
H. Lee Moffitt Cancer Center & Research Institute |
A Single Arm Phase II Study of Gemcitabine and Irinotecan in Patients with Metastatic Breast Cancer |
Pedro Ramirez, MD |
The University of Texas M.D. Anderson Cancer Center |
Phase I Trial of Concurrent Weekly CPT-11, Cisplatinum, and Radiotherapy for Patients with Newly Diagnosed Stage IIIb-IVa Cancer of the Uterine Cervix |
M. Wasif Saif, MD, MBBS |
University of Alabama at Birmingham Comprehensive Cancer Center |
A Phase I and Pharmacologic Trial of Sequential Administration of Bi-weekly Gemcitabine as a 24-hour IV Infusion followed by Irinotecan as a 24-hour IV Infusion in Adult Cancer Patients |
Charles Shapiro, MD |
The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute |
Phase II Study of Sequentially Administered Mitomycin and Irinotecan in Patients with Refractory Metastatic and Inflammatory Breast Cancers |
Clinical Studies for Celecoxib
INVESTIGATOR |
MEMBER INSTITUTION |
STUDY |
Manuel Hidalgo, MD, PhD |
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Biological Evaluation of Celecoxib in Pancreatic Cancer |
Milind Javle, MD |
Roswell Park Cancer Institute |
Celecoxib in Combination with Irinotecan (CPT-11), 5-Fluorouracil and Leucovorin in Patients with Advanced Cancer. A Phase I Study |
Ritsuko Komaki, MD, FACR |
The University of Texas M.D. Anderson Cancer Center |
A Phase I Study of Concurrent CPT-11/Cisplatin and Celecoxib with Radiation Therapy for Patients with Unresectable Non-Small Cell Lung Cancer (NSCLC) |
Nancy Lewis, MD |
Fox Chase Cancer Center |
A Randomized Trial of Celecoxib +/- Rosiglitazone vs. Placebo in Patients with Early Stage Non-Invasive Bladder Carcinoma |
Brian Rini, MD |
UCSF Helen Diller Family Comprehensive Cancer Center |
A Phase II Trial of Celecoxib Plus Interferon-Alpha in Advanced Renal Cell Carcinoma |
Manisha Shah, MD |
The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute |
Phase II Study of Celecoxib in Metastatic Differentiated Thyroid Carcinoma |
Charles Shapiro, MD |
The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute |
A Phase II Trial of Exemestane (Aromasin) in Combination with Celecoxib (Celebrex) as Neoadjuvant Treatment in Postmenopausal Women with Stage II, III, and IV Breast Cancer |
Przemyslaw Twardowski, MD |
City of Hope Comprehensive Cancer Center |
Biologic Markers of Angiogenesis: A Companion Study to Phase I Trial of Oral Etoposide in Combination with Celecoxib in Patients with Advanced Malignancies and Phase I Trial of Oral Cyclophosphamide in Combination with Celecoxib in Patients with Advanced Malignancies |
Clinical Studies for Capecitabine
INVESTIGATOR |
MEMBER INSTITUTION |
STUDY |
Tanios Bekaii-Saab, MD |
The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute |
A Dose Escalating (Phase I) Study Looking at the Biomodulation of Capecitabine by Docetaxel and Gemcitabine in Patients with Advanced Pancreatic Cancer |
Renuka Iyer, MD |
Roswell Park Cancer Institute |
Multicenter, Open Label, Phase II Clinical Study of Gemcitabine, Capecitabine and Avastin in Pancreatic Cancer |
Milind Javle, MD |
Roswell Park Cancer Institute |
Phase II Study of Capecitabine in Combination with Oxaliplatin and Radiotherapy for Esophageal and Gastroesophageal Junction Cancer |
| Kimberly Jones, MD | Huntsman Cancer Institute at the University of Utah | A Phase I Study, with expanded cohort, of Biweekly Fixed-Dose Rate Gemcitabine plus Capecitabine in Patients with Advanced Pancreatic and Biliary Carcinomas | Andrew Ko, MD |
UCSF Helen Diller Family Comprehensive Cancer Center |
A Phase I Study, with expanded cohort, of Biweekly Fixed-Dose Rate Gemcitabine plus Capecitabine in Patients with Advanced Pancreatic and Biliary Carcinomas |
Wells Messersmith, MD |
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Thymidylate Synthase (TS) Genotype-Directed Phase II Trial of Oral Capecitabine for 2nd Line Treatment of Advanced Pancreatic Cancer |
Mary Mulcahy, MD |
Robert H. Lurie Comprehensive Cancer Center of Northwestern University |
A Phase II Study of Capecitabine and Oxaliplatin with Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma |
Lakshmi Pendyala, PhD |
Roswell Park Cancer Institute |
Gene Expression Profiling of Esophageal Cancer in Patients Receiving Oxaliplatin, Capecitabine and Radiation, Exploring Correlations to Response |
M. Wasif Saif, MD, MBBS |
Yale University School of Medicine |
A Phase I/II, Open-Label, Dose Escalation, Safety and Efficacy Study of PHY906 Plus Capecitabine in Patients with Advanced Pancreatic Carcinoma |
| Hope Uronis, MD | Duke Comprehensive Cancer Center | Correlative Biomarker Proposal for A Phase II Study of Oxaliplatin, Capecitabine, and Bevacizumab in the Treatment of Metastatic Esophagogastric Adenocarcinoma |
Robert Warren, MD |
UCSF Helen Diller Family Comprehensive Cancer Center |
A Retrospective Analysis of Thymidylate Synthase (TS) and Thymidine Phosphorylase (TP) Levels and Thymidylate Synthase (TS) Genetic Polymorphisms from Archived Hepatocellular Carcinoma (HCC) Surgical Specimens |
Preclinical Studies for Sunitinib
INVESTIGATOR |
MEMBER INSTITUTION |
STUDY |
Long Dang, MD, PhD |
University of Michigan Comprehensive Cancer Center |
Targeting Tumor Reactive Response to Antiangiogenic Therapy |
Frank Fitzpatrick, PhD |
Huntsman Cancer Institute at the University of Utah |
Molecular Determinants of Sunitinib Efficacy |
Roberto Pili, MD |
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Vertical Inhibition of the VEGF Pathway with Sunitinib in Combination with HDAC and mTOR Inhibitors in Renal Cell Carcinoma Models |
Sabina Signoretti, MD and |
Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts General Hospital Cancer Center |
Therapy of Renal Cell Carcinoma with Sutent: Mechanism of Acquired Resistance |
John Sunwoo, MD, FACS |
Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine |
Preclinical Evaluation of Sunitinib in Squamous Cell Carcinoma of the Head and Neck |
Michael Wong, MD, PhD, FRCPC |
Roswell Park Cancer Institute |
Inhibition of Human Angiosarcoma and Reversal of Chemoresistance by Sunitinib |
Sam Yoon, MD |
Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts General Hospital Cancer Center |
Sunitinib with and without Radiation Therapy: Analysis in a Novel Mouse Model of Soft Tissue Sarcomas |
Specialized Imaging Studies for Sunitinib
INVESTIGATOR |
MEMBER INSTITUTION |
STUDY |
John Hoffman, MD |
Huntsman Cancer Institute at the University of Utah |
Sunitinib for Metastatic Renal Cell Cancer with Imaging Biomarker Assessments for the Early Prediction of Tumor Response |
Robert G. Maki, MD, PhD |
Memorial Sloan-Kettering Cancer Center |
18FDG-PET As a Means to Determine Clinical Response in Soft Tissue Sarcomas in Patients Receiving a Continuous Daily Dosing Schedule of Sunitinib |
Andrew Quon, MD |
Stanford Comprehensive Cancer Center |
Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using FDG PET/CT, MRI, and DEC MRI |
Jennifer Specht, MD |
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance |
DCE-MRI and FDG-PET with Kinetic Analysis to Monitor Breast Cancer Response to Neoadjuvant Sunitinib and Metronomic Chemotherapy |
Clinical Studies for Abraxane®
INVESTIGATOR |
MEMBER INSTITUTION |
STUDY |
Mihaela Cristea, MD |
City of Hope Comprehensive Cancer Center |
Phase I Trial of Intraperitoneal nab-paclitaxel (Abraxane®) in the Treatment of Advanced Malignancies Primarily Confined to the Peritoneal Cavity |
Grace Dy, MD |
Roswell Park Cancer Institute |
SPARC Expression in NSCLC is Correlated with Response to nab-paclitaxel |
Matthew G. Fury, MD, PhD |
Memorial Sloan-Kettering Cancer Center |
Phase I Study of Weekly Nanoparticle Albumin-Bound Paclitaxel (AbraxaneŽ) + Weekly Cetuximab + Radiation Therapy (IMRT, Intensity-Modulated Radiation Therapy) in Patients with Stage III-IVB Head and Neck Squamous Cell Carcinoma (HNSCC) |
| Razelle Kurzrock, MD | The University of Texas M.D. Anderson Cancer Center | Phase I Trial of Hepatic Arterial Infusion of Abraxane with a Pharmacokinetic Study in Advanced Solid Cancer Patients with Predominant Hepatic Metastases |
Thomas Olencki, DO |
The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute |
A Phase 2 Study of Weekly Infusion nab-paclitaxel (paclitaxel protein-bound particles for injectable suspension) in Patients with Unresectable and Metastatic Uveal Melanoma |
Gregory A. Otterson, MD |
The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute |
Phase II Trial of Abraxane plus Carboplatin for Advanced NSCLC for Patients at Risk of Bleeding from VEGF Directed Therapies |
| Jasgit Sachdev, MD | University of Tennessee Cancer Institute | Neoadjuvant Weekly nab-paclitaxel (Abraxane®) Plus Carboplatin Followed by Doxorubicin Plus Cyclophosphamide with Bevacizumab Added Concurrently to Chemotherapy for Palpable and Operable Triple Negative Invasive Breast Cancer |
Clinical Studies for Cetuximab
COORDINATING CENTER/PROJECT CHAIR |
PARTICIPATING MEMBER INSTITUTION/PRINCIPAL INVESTIGATOR |
STUDY |
University of Michigan Comprehensive Cancer Center/Maha Hussain, MD, FACP |
City of Hope Comprehensive Cancer Center/Przemyslaw Twardowski, MD |
Phase II Randomized Trial of Gemcitabine and Cisplatin with or without Cetuximab in Patients with Urothelial Carcinoma |
Huntsman Cancer Institute at the University of Utah/Neeraj Agarwal, MD |
||
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance/Evan Yu, MD |
||
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins/Mario Eisenberger, MD |
||
Robert H. Lurie Comprehensive Cancer Center of Northwestern University/Gary MacVicar, MD |
||
Roswell Park Cancer Institute/Ellis Levine, MD |
||
Stanford Comprehensive Cancer Center/Sandy Srinivas, MD |
||
The University of Texas M.D. Anderson Cancer Center/Arlene Siefker-Radtke, MD |
||
Vanderbilt-Ingram Cancer Center/Bruce Roth, MD |
||
Memorial Sloan-Kettering Cancer Center/Matthew Fury, MD, PhD |
City of Hope Comprehensive Cancer Center/Dean Lim, MD |
A Phase II Randomized Study of Cetuximab at Either 500 or 750 mg/m2 Every Other Week for Recurrent or Metastatic Head and Neck Squamous Cell Cancer |
| Fox Chase Cancer Center/Ranee Mehra, MD | ||
Robert H. Lurie Comprehensive Cancer Center of Northwetern University/Bruce Brockstein, MD |
||
H. Lee Moffitt Cancer Center & Research Institute/Tawee Tanvetyanon, MD |
||
University of Tennessee Cancer Institute/Furhan Yunus, MD |
||
UNMC Eppley Cancer Center at The Nebraska Medical Center/Sandeep Rajan, MD |
Clinical Studies for Bendamustine
INVESTIGATOR |
MEMBER INSTITUTION |
STUDY |
Marc C.Chamberlain, MD |
University of Washington |
A Phase II Study of Bendamustine (Cephalon, Inc.) in the Treatment of Recurrent High-Grade Gliomas (Anaplastic Gliomas and Glioblastoma) |
John C. Grecula, MD |
The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute |
Phase I Study of Bendamustine and Fractionated Stereotactic Radiotherapy (SRT) for Patients with 1-3 Brain Metatases from Solid Malignancies |
Rachel M. Layman, MD |
The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute |
Phase I/II Study of Bendamustine and Erlotinib for Metastatic or Locally Advanced Triple Negative Breast Cancer |
Edward Pan, MD |
H. Lee Moffitt Cancer Center & Research Institute |
Phase I Study of Bendamustine with Concurrent Whole Brain Radiation Therapy in Patients with Brain Metastases from Solid Tumors |
Francisco Robert, MD |
University of Alabama at Birmingham Comprehensive Cancer Center |
UAB 0818 - Phase I/IIa Study of the Novel Combination of Bendamustine with Irinotecan Followed by Etoposide/Carboplatin in Chemonaive Patients with Extensive Stage Small Cell Lung Cancer |
Clinical Studies for Vorinostat
| INVESTIGATOR | MEMBER INSTITUTION | STUDY |
John R. Adler, Jr., MD |
Stanford Comprehensive Cancer Center |
Phase I/II Trial of Vorinostat Concurrent with Radiotherapy in Treatment of Brain Metastases from Non-Small Cell Lung Cancer |
Emily Chan, MD, PhD |
Vanderbilt-Ingram Cancer Center |
Phase I Trial of Chemoradiation with Capecitabine and Vorinostat in Pancreatic Cancer |
Ranee Mehra, MD |
Fox Chase Cancer Center |
Phase I Study of the HDAC Inhibitor Vorinostat with Chemotherapy and Radiation Therapy for the Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC) |
Theodoros N. Teknos, MD |
The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute |
A Phase I/II Trial of Vorinostat in the Treatment of Advanced Oropharyngeal Carcinoma of the Head and Neck |
Clinical Studies for Temsirolimus
| INVESTIGATOR | MEMBER INSTITUTION | STUDY |
Jeffrey Allen, MD |
University of Tennessee Cancer Institute |
A Phase I/II Trial of the Combination of Cisplatin, Cetuximab, and Temsirolimus in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck |
Andrew Armstrong, MD |
Duke Comprehensive Cancer Center |
Impact of Temsirolimus Therapy on Circulating Tumor Cell Biology in Castration Resistant Metastatic Prostate Cancer: A Pilot Study |
Oren J. Becher, MD |
Memorial Sloan-Kettering Cancer Center |
Phase I Trial of Perifosine + Temsirolimus for Recurrent Solid Tumors in Pediatrics |
Susana M. Campos, MD, MPH |
Dana-Farber/ Brigham and Women's Cancer Center |
The Safety and Efficacy of Combination Therapy with AZD2171 and Temsirolimus in Patients with Recurrent Gynecological Malignancies |
Sarat Chandarlapaty, MD, PhD |
Memorial Sloan-Kettering Cancer Center |
A Phase I/II Trial of Temsirolimus plus Neratinib in Patients with Metastatic HER2-Amplified or Triple Negative-EGFR Expressing Breast Cancer |
Warren A. Chow, MD |
City of Hope Comprehensive Cancer Center |
Phase II Trial of Temsirolimus and AZD6244 for Soft-Tissue Sarcomas |
Matthew G. Fury, MD, PhD |
Memorial Sloan-Kettering Cancer Center |
Phase I/II Study of Temsirolimus + Paclitaxel + Carboplatin in Advanced HNSCC |
David Loeb, MD |
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Temsirolimus Augmentation of Chemotherapy for High Risk Sarcomas |
Halla Nimeiri, MD |
Robert H. Lurie Compehensive Cancer Center of Northwestern University |
A Phase I/II Study of the Combination of Temsirolimus and Sorafenib in Advanced Hepatocellular Carcinoma |
Eric Sherman, MD |
Memorial Sloan-Kettering Cancer Center |
Phase II Study Evaluating the Combination of Temsirolimus and Sorafenib in the Treatment of Radioactive Iodine Refractory Thyroid Cancer |
Sandhya Srinivas, MD |
Stanford Comprehensive Cancer Center |
Using Temsirolimus, an mTOR Inhibitor, to Reverse Androgen Insensitivity in Patients with Castration-Resistant Prostate Cancer |
Alan Venook, MD |
UCSF Helen Diller Family Comprehensive Cancer Center |
A Phase I/II Study of the Combination of Temsirolimus and Sorafenib in Advanced Hepatocellular Carcinoma |