Research Projects & Grants

College/University

• Phase II trial of Rituximab and autologous stem cell transplantation for refractory B cell large cell lymphoma, Role: Investigator, Johns Hopkins Oncology Center / Berlex, (01/2006 - 01/2007) Status: Completed
• Phase II study of mobilization with intermediate or high dose filgrastim after ESHAP chemotherapy for intermediate and high grade lymphomas, Role: Investigator, Johns Hopkins University, Status: Completed

Federal

• RTOG 96-16: A phase III study of adjuvant chemotherapy after resection for patients with T2N0 stage I non-small cell carcinoma of the lung, Role: Investigator, National Cancer Institute/NIH/DHHS, (07/2008 - 07/2009) Status: Completed
• NSABP B-21. A clinical trial to determine the worth of tamoxifen and the worth of breast radiation in the management of patients with node-negative, occult, invasive breast cancer treated by lumpectomy, Role: Investigator, National Cancer Institute/NIH/DHHS, (08/2006 - 08/2007) Status: Completed
• BCPT P-1. A clinical trial to determine the worth of tamoxifen for preventing breast cancer, Role: Investigator, National Cancer Institute/NIH/DHHS, (04/2006 - 04/2007) Status: Completed
• A multi-center pilot study of high-dose immunoablative therapy using total body irradiation, anti-thymocyte globulin and cyclophosphamide followed by autologous transplantation with CD34 selected peripheral blood stem cells for patients with systemic sclerosis, Role: Investigator, National Institutes of Health/DHHS, (05/2005 - 05/2006) Status: Completed
• SWOG 9625 Weekly dose-intensive Doxorubicin with daily oral Cyclophosphamide and continous G-CSF as neoadjuvant therapy for locally advanced and inflammatory breast cancer, Phase II, Role: PI, National Cancer Institute/NIH/DHHS, (01/2005 - 01/2006) Status: Completed
• FHCRC - 1630.00 - a multi-center pilot study of high-dose immunoablative therapy using cyclophosphamide and anti-thymocyte globulin and followed by autologous or syngeneic peripheral blood stem cell transplantation for patients with refractory systemic lupus erythematosus, Role: Investigator, National Institutes of Health/DHHS, (05/2003 - 05/2004) Status: Completed
• SWOG 9520: Controlled phase II study of doxorubicin and paclitaxel as frontline chemotherapy for women with metastatic breast cancer, Role: PI, National Institutes of Health/DHHS, (07/1997 - 07/1998) Status: Completed

For Profit Organization

• Mirati Therapeutics,Inc., 265-109: Phase 2, parallel-arm study of MGCD265 in patients with locally advanced or metastatic non-small cell lung cancer with activating genetic alterations in mesenchymal-epithelial transition factor, Role: Investigator, Mirati Therapeutics, (10/2017 - 10/2018) Status: Completed
• Daiichi Sankyo Pharma Development - DS2248-A-U101 - A phase 1, open label, multiple-ascending dose study of DS-2248, an orally biovailable heat shock protein 90 inhibitor in subjects with advance solid tumors, Role: Investigator, Daiichi Sankyo Pharma Development, (05/2014 - 05/2015) Status: Completed
• Merrimack Pharmaceuticals - MM-121-01-101: A phase 1-2 trial of MM-121 in combination with erlotinib in three groups of patients with non-small cell lung cancer, Role: Investigator, Merrimack Pharmaceuticals, (11/2013 - 10/2014) Status: Completed
• OX-03-005 - A Phase II study to evaluate the efficacy and safety of Xeloda and Oxaliplatin (Xelox) as 2nd line treatment of patients with colorectal cancer who failed previous therapy with Irinotecan based regimen, Role: Investigator, Sanofi-Synthelabo Pharmaceuticals, (05/2007 - 05/2008) Status: Completed
• Prospective observational study of mylotarg (gemtuzumab ozogamicim) in usual care, Role: Investigator, Wyeth-Ayerst Laboratories, (01/2007 - 01/2008) Status: Completed
• IMMUNEX 54.0009 - a clinical trial of the safety and efficacy of ABX - EGF in combination with Irinotecan, Leucovorin, and 5-Fluorouacil in patients with metastatic colorectal cancer, Role: Investigator, Immunex/Abgenix, (01/2006 - 01/2007) Status: Completed
• Immunex 54.0005 - an open label phase 2 clinical trial to evaluate the safety and efficacy of abx-egf in patients with metastatic colorectal carcinoma., Role: Investigator, Immunex/Abgenix, (01/2006 - 01/2007) Status: Completed
• GlaxoSmithKline - NKV101983 - A Phase II multicenter, randomized, double-blind, placebo-controlled, dose-ranging, parallel group study of the safety and efficacy of the oral neurokinin-1 receptor antagonist, GW679769, when administered as 50 mg, 100mg, and 150 mg oral tablets in combination with ondansetron hydrochloride and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in cancer subjects receiving moderately emetogenic chemotherapy, Role: Investigator, GlaxoSmithKline, (10/2005 - 10/2006) Status: Completed
• A pilot study of escalating doses of Thalidomide combined with COX-2 inhibitor (Celecoxib) for treatment of unresectable recurrent soft tissue sarcoma, Role: PI, Celgene, Inc., (08/2005 - 08/2006) Status: Completed
• IDEC 106-1001 - Phase II trial of Zevalin (Ibritumomab Tiuxetan) followed by Rituxan (Rituximab) maintenance in previously treated low grade non-Hodgkin's Lymphoma, Role: Investigator, IDEC Pharmaceuticals Corporation, (06/2005 - 06/2006) Status: Completed
• SWOG S0205 - A Phase III, randomized open-label study comparing gemcitabine plus cetuximab (IMC-C225) versus gemcitabine as first-line therapy of patients with advanced pancreatic cancer, Role: Investigator, Southwest Oncology Group, (05/2005 - 05/2006) Status: Completed
• AMGEN - Protocol 20030206 - SYNCHRONICITY: A study to evaluate the effectiveness of Aranesp® at 300 mcg q3w on clinical outcomes in cancer patients with anemia due to chemotherapy, Role: Investigator, Amgen, Inc., (05/2005 - 05/2006) Status: Completed
• Millennium M34101-039: an international, multi-center, randomized, open-label study of PS-341 versus high-dose dexamethasone in patients with relapsed or refractory multiple myeloma, Role: Investigator, Millennium Pharmaceuticals, Inc., (03/2005 - 03/2006) Status: Completed
• SWOG 9318. Recombinant Human Erythropoietin (r-HuEPO) as an Adjunct to Radiation Therapy and Cisplatin for Patients with Stages II-B, III and IV-A Carcinoma of the Cervix. Phase II, Role: PI, Southwest Oncology Group, (01/2005 - 01/2006) Status: Completed
• AMG 531 20030105 - A randomized, placebo controlled study evaluating the efficacy and safety of AMG 531 treatment of thrombocytopenic subjects with immune (idiopathic) thrombocytopenic purpura (ITP) refractory to splenectomy, Role: Investigator, Amgen, Inc., (01/2005 - 01/2006) Status: Completed
• A randomized phase II trial of two chemotherapy combination regimens (Docetaxel/Irinotecan or Gemcitabine/Irinotecan with or without Celecoxib) in patients with advanced non-small cell lung cancer that has failed one prior regimen of anti-cancer treatment CPTAIV-0020-362., Role: PI, Pharmacia, (12/2004 - 12/2005) Status: Completed
• S9916 Docetaxel and estramustine versus mitoxantrone and prednisone for advanced, hormone refractory prostate cancer, Phase III, Role: Investigator, Southwest Oncology Group, (08/2004 - 08/2005) Status: Completed
• SWOG 88-92. A Phase III Study of Radiotherapy With or Without Concurrent Cisplatin in Patients with Nasopharyngeal Cancer, Role: PI, Southwest Oncology Group, (08/2004 - 08/2005) Status: Completed
• Roche-ML 16323 A phase II study of oral Xeloda in combination with intravenous irinotecan in patients with locally advanced and/or metastatic colorectal cancer, Role: Investigator, Roche Laboratories Inc., (08/2004 - 08/2005) Status: Completed
• Millenium M34101-040-an international, non-comparative, open-label study of PS-341 administered to patients with multiple Myeloma who experienced relapsed or progressive disease after receiving at least four previous treatment regimens or experienced progressive disease after Dexamethasone in Millennium Protocol M34101-039a, Role: Investigator, Millennium Pharmaceuticals, Inc., (07/2004 - 07/2005) Status: Completed
• Super-Gen-D-0007 A randomized, open label, phase III trial of decitabine versus supportive care in adults with advanced-stage of myelodysplastic syndrome [Protocol Version dated 10/26/01; Amendment #3], Role: PI, SUPERGEN, (02/2004 - 02/2005) Status: Completed
• AMGEN Protocol Number 20020122 - a randomized, open label, multicenter study of primary prophylaxis with Neulasta (pegfilgrastim) versus secondary prophylaxis as an adjunct to chemotherapy in elderly subjects (>65 y.o.) with cancer, Role: Investigator, Amgen, Inc., (01/2004 - 01/2005) Status: Completed
• A phase II study of Nipent (pentostatin) in low grade malignancy non-Hodgkin's lymphomas, Role: PI, SUPERGEN, (11/2003 - 11/2004) Status: Completed
• SWOG-E3695. A randomized phase III trail of concurrent biochemistry with cisplatin, vinblastine, dacarbazine alone in patients with metastatic malignant melanoma, Role: Investigator, Southwest Oncology Group, (11/2001 - 11/2002) Status: Completed
• AMGEN-A Pilot Study Evaluating the Impact of Chemotherapy-Induced Febrile Neutropenia (FN) on the Health Related Quality of Life (HRQOL) of Patients with Breast Cancer Diagnosis Receiving Docetaxel and Doxorubicin Chemotherapy, Role: PI, Amgen, Inc., (11/2001 - 11/2002) Status: Completed
• Phase III randomized study of RFS 2000 (9-Nitro camptothecin, RFS 2000) versus gemcitabine HCl in chemonaive pancreatic cancer patients, Role: Investigator, SUPERGEN, (08/2001 - 08/2002) Status: Completed
• Determination of the therapeutic efficacy and safety of S-59 photochemically treated platelets in thrombocytopenic patients, Role: PI, Baxter Healthcare Corporation, (04/2001 - 04/2002) Status: Completed
• Phase III randomized study of RFS 2000 (9-Nitro-camptothecin, 9-NC) versus 5fluorouracil (5-FU) in pancreatic cancer patients that have progressive disease following gemcitabine HCl treatment, Role: Investigator, SUPERGEN, (09/2000 - 09/2001) Status: Completed
• SWOG 92-10 - A phase III randomized trial of combination therapy for multiple myeloma comparison of (1) VAD-P to VAD-P quinine for induction; (2) randomization of prednisone dose intensity for remission maintenance, Role: PI, Southwest Oncology Group, (09/2000 - 09/2001) Status: Completed
• SWOG-S9804. Evaluation of vinorelbine tartrate (Navelbine) in patients with disseminated malignant melanoma and at least one prior systemic therapy phase II, Role: Investigator, Southwest Oncology Group, (07/2000 - 07/2001) Status: Completed
• SWOG R9704: A phase III study of pre and post chemoradiation 5-FU vs pre and post radiation gemcitabine for postoperative adjuvant treatment of resected pancreatic adenocarcinoma, Role: Investigator, Southwest Oncology Group, (05/2000 - 05/2001) Status: Completed
• Hoffman La Roche Protocol #SO14695. An open label randomized phase 3 study comparing capecitabine with 5-fluorouracil in combination with leucovorin as first-line chemotherapy in patients with advanced and/or metastatic colorectal carcinoma, Role: Investigator, Hoffmann-La Roche Inc., (08/1999 - 08/2000) Status: Completed
• SWOG 9626: A phase III trial of placebo versus megestrol acetate 20 mg/day versus megestrol acetate 40 mg/day as treatment for symptoms of ovarian failure in women treated for breast cancer, Role: PI, Southwest Oncology Group, (06/1999 - 06/2000) Status: Completed
• SCHERING-PLOUGH C97-042. Comparison of the effects of SCH 57050 and anastrozole in subjects with breast cancer relapsing after initial response to tamoxifen or showing progression after tamoxifen given as an adjuvant to surgery: A prospective double-blind phase III trial, Role: Investigator, Schering Plough, (03/1999 - 03/2000) Status: Completed
• SWOG 9003. Fludarabine for Waldenstrom's macroglobulinemia (WM): A phase II pilot study for untreated and previously treated patients., Role: PI, Southwest Oncology Group, (08/1997 - 08/1998) Status: Completed
• PR95-27-014. Clinical evaluation of PROCRIT in the treatment of anemic cancer patients receiving chemotherapy, Role: PI, Ortho Biotech. Inc., (03/1996 - 03/1997) Status: Completed
• SWOG 92-52. Prospective randomized trial of postoperative adjuvant therapy in patients with completely resected stage II and stage IIIa non-small lung cancer, Role: PI, Southwest Oncology Group, Status: Completed
• SWOG-N9741 A randomized phase III trial of combinations of oxaliplatin, 5-fluorouracil, and irinotecan as initial treatment of patients with advanced adenocarcinoma of the colon and rectum., Role: Investigator, Southwest Oncology Group, Status: Completed
• Ortho Bio Tech PR00-27-012. An open-label study of PROCRIT in women undergoing adjuvant chemotherapy for Stage I, II or III breast cancer (Protocol version Amendment #1, dated June 13, 2000), Role: Investigator, Ortho Biotech. Inc., Status: Completed
• Duke University Medical Center - Phase 2 Treatment of adults with brain metastases with temodar, Role: Investigator, Schering Plough, Status: Completed
• SWOG-S0007 Evaluation of 3 hour infusion paclitaxel plus cisplatin and 5-fluorouracil in patients with advanced or recurrent squamous cell carcinoma of the head and neck, phase II, Role: PI, Southwest Oncology Group, Status: Completed
• SWOG-S9807 Repository for paraffin embedded tissues from patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), Role: PI, Southwest Oncology Group, Status: Completed
• 440E-ONC-0020-319 - Phase II, Single-Arm Trial of CPT-11 (Irinotecan HCI; Camptosar™ Injection)/ Cisplatin in Patients with Advanced Esophageal Cancer, Role: Investigator, Pharmacia, Status: Completed
• NOVARTIS Protocol # CZOL446EUS16 - A Prospective, Multicenter, Open-label Clinical Evaluation of the Effect of I.V. Zometa 4mg on Pain, Quality of Life and Time in Infusion Chair in Breast Cancer, Multiple Myeloma, and Prostate Cancer Patients with Cancer-Related Bone Lesions, Role: PI, Novartis Pharma AG, Status: Completed
• AMGEN - 20020132 - A study to assess symptom burden in subjects with nonmyeloid malignancies receiving chemotherapy and Aranesp TM, Role: Investigator, Amgen, Inc., Status: Completed
• SWOG 93-06. Phase II intergroup study of conservative treatment of adenocarcinoma of the distal rectum: Local excision plus adjuvant radiation and concurrent 5-FU in selected patients, Role: PI, Southwest Oncology Group, Status: Completed

Internal

• A pilot study to assess the effects of hemopoietic stem cell transplantation on skeletal metabolism, Role: Investigator, LLU Dept. of Medicine, Status: Completed
• Astra-Zeneca ZD 1839 An expanded access clinical program with ZD 1839 (IRESSA) for patients with advanced non-small cell lung cancer (NSCLC), Role: Investigator, LLU Dept. of Medicine, Status: Completed

Non-Profit Organization

• NSABP B43: 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, Role: Investigator, National Surgical Adjuvant Breast & Bowel Project, (12/2024 - 12/2025) Status: Approved
• NSABP - FB-7: A phase II randomized clinical trial evaluating neoadjuvant therapy regimens with weekly paclitaxel plus neratinib or trastuzumab or neratinib and trastuzumab followed by doxorubicin and cyclophosphamide with postoperative trastuzumab in women with locally advanced HER2-positive breast cancer, Role: Investigator, National Surgical Adjuvant Breast & Bowel Project, (07/2017 - 07/2018) Status: Completed
• NSABP B-29. A clinical trial to evaluate the benefit of adding octreotide (SMS 201-995 PA LAR) to tamoxifen alone or to tamoxifen and chemotherapy in patients with axillary node-negative, estrogen-receptor-positive, primary invasive breast cancer., Role: Investigator, National Surgical Adjuvant Breast & Bowel Project, (04/2006 - 04/2007) Status: Completed
• B9E-MC-X315-A phase II trial of gemcitabine and cisplatin in previously untreated patients with advanced unresectable biliary tract and gallbladder cancer, Role: Investigator, Lilly Endowment, Inc., (09/2004 - 09/2005) Status: Completed
• Duke University Medical Center - Phase 2 treatment of adults with progressive or recurrent primary central nervous system lymphoma with temodar, Role: Investigator, Duke University Medical Center, (05/2004 - 05/2005) Status: Completed
• BMS-CAA225014 EXPLORE - A Phase III randomized multicenter study of Cetuximab, Oxaliplatin, 5-Fluorouracil, and Leucovorin vs. Oxaliplatin, 5-Fluorouracil, and Leucovorin in patients with previously treated metastatic, EGFR-positive colorectal carcinoma, Role: Investigator, Bristol-Myers Squibb Foundation, Inc., (01/2004 - 01/2005) Status: Completed
• A phase II trial of paclitaxel administered as a weekly one hour infusion in patients with advanced esophageal cancer, Role: PI, Bristol-Myers Squibb Foundation, Inc., (11/2000 - 11/2001) Status: Completed
• (Bristol/Theradex) A phase II trial of paclitaxel (taxol) administered as a weekly one hour infusion in previously treated patients with head and neck cancers, Role: PI, Bristol-Myers Squibb Foundation, Inc., (10/2000 - 10/2001) Status: Completed
• RTOG-9914 A phase II trial of concomitant boost radiation and concurrent cisplatin for advanced head and neck carcinomas, Role: Investigator, Radiation Therapy Oncology Group, (08/2000 - 08/2001) Status: Completed
• A phase II study of ORZEL given as a twice-daily regimen in the treatment of patients with metastatic colorectal cancer, Role: Investigator, Bristol-Myers Squibb Foundation, Inc., (02/2000 - 02/2001) Status: Completed
• Lilly Protocol B9E-MC-JHGA9c. A randomized phase 3 study of gemcitabine plus cisplatin versus MVAC chemotherpy in advanced or metastatic transitional cell carcinoma of the urothelium., Role: PI, Lilly Endowment, Inc., (08/1998 - 08/1999) Status: Completed
• NSABP-B33 - Treatment with or without Exemestane for breast cancer patients who are disease free after having completed Tamoxifen therapy, Role: PI, National Surgical Adjuvant Breast & Bowel Project, Status: Completed