Research
CICC Clinical Trials
Current Protocols: updated 7/29/10
Central Scheduling: 317-356-2422
Breast Cancer
Phase II Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women who have Hormone Receptor-positive Advanced Breast Cancer Previously Treated with an Aromatase Inhibitor
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Phase II, multicenter, open-label, clinical trial of Trabectedin (Yondelis®) in Metastatic Breast Cancer Patients with triple negative profile (ER-, PR-, HER2-), HER2 overexpressing tumors and BRCA1 or BRCA2 mutation carriers. Grant exceptions for pts in all subgroups to enroll without prior Capecitabine Arm A- triple neg closed; ArmB-Her2overexpress hold; ArmC- Familiar BRCA1or BRCA2
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Randomized Phase II Trial of Letrozole with or without Dasatinib as First-Line Treatment for Hormone Receptor-Positive, HER2-Negative Post-Menopausal Breast Cancer that is Unresectable, Locally Recurrent or Metastatic
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A Phase III Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Brst Ca NSABPB-46-I – A Phase 2, Open-Label Study of EZN-2208 (PEG-SN38) in Patients with Previously Treated
Metastatic Breast Cancer
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Phase II Trial of Ixabepilone plus Carboplatin in Patients with Metastatic Breast Cancer
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A Randomized Double Blind Placebo-Controlled Trial of Neratinib (HKI-272) Following Trastuzumab in Women With Early-Stage HER-2/neu + Breast Ca
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A randomized phase III, double-blind, placebo-controlled multicenter trial of everolimus in combination with trastuzumab and paclitaxel, as first line therapy in women with HER2-positive locally advanced or metastatic breast cancer
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A Randomized Discontinuation Study of XL184 in Subjects with Advanced Solid Tumors: Breast- ER positive, or inflammatory breast cancer, regardless of the hormonal receptor status up to three prior standard tx
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A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer (RTOG)
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A Phase III Clinical Trial Comparing Trastuzumab Given Concurently with Radiation and Radiation Alone for Women with Her2-Postive DCIS Resected by Lumpectomy
Colorectal / Gastrointestinal
A Multi-center, Open-label, Randomized, Phase 2 Clinical Trial Evaluating Safety and Efficacy of FOLFIRI with Either Panitumumab or Bevacizumab as Second-line Treatment in Subjects with Metastatic Colorectal Cancer (SPIRITT- Second-line Panitu-IRInotecan Treatment Trial)
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Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-Line Treatment of KRAS-Mutant Colorectal Carcinoma
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A Randomized Discontinuation Study of XL184 in Subjects with Advanced Solid Tumors: GE and GE Junc., -excluding carcinoids- up to 1 prior standard tx – Pancreatic adenocarcinoma excluding neuroendocrine tumors-up to 1 prior standard tx
Lung Cancer-NSCLC
Randomized, Open-Label, Phase 3 Study of Pemetrexed plus Carboplatin and Bevacizumab Followed by Maintenance Pemetrexed and Bevacizumab versus Paclitaxel plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients with Stage IIIB or IV Nonsquamous NSCLC
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FORTIS-M: A Phase 3, randomized, double-blind, placebo-controlled study of oral talactoferrin in addition to best supportive care in patients with NSCLC who have failed two or more prior treatment regimens
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Phase III, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of ASA404 in Combination with Docetaxel in Second-Line Treatment of Patients with Locally Advanced or Metastatic (Stage IIIb/IV) Non-Small Cell Lung Cance
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy
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A Randomized Discontinuation Study of XL184 in Subjects with Advanced Solid Tumors: NSCLC- all histological subtypes-up to 3 prior standard tx
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Randomized, phase III, open-label study of oral topotecan plus whole-brain radiation tx (WBRT) compared with WBRT alone in patients with brain metastases from Non-Small Cell Lung Cancer
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Randomized Phase III Comparison Of Standard- Dose (60 Gy) Versus Highdose (74 Gy) Conformal Radiotherapy With Concurrent And Consolidation Carboplatin/Paclitaxel In Patients With Stage IIIa/IIIb NSCLC
Lung Cancer-SCLC
A Randomized Discontinuation Study of XL184 in Subjects with Advanced Solid Tumors: SCLC of all histological subtypes-up to 2 prior standard tx
Prostate
A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib Plus Prednisone Versus Prednisone In Patients With Progressive Metastatic Hormone-Refractory Prostate Cancer After Failure Of A Docetaxel-Based Chemotherapy Regimen -
Phase 3 Study to Evaluate the Efficacy and Safety of Docetaxel and Prednisone with or w/out Lenalidomide in Subjects with Castrate-Resistant Prostate Cancer (CRPC)
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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
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A Randomized Discontinuation Study of XL184 in Subjects with Advanced Solid Tumors: Prostate-Androgen independent adenocarcinoma- up to 1prior standard tx
A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer – RTOG 081
Renal/Urothelial
Phase II Trial of Gemcitabine, Cisplatin, and Sunitinib in Patients with Advanced/Metastatic Urothelial Carcinoma
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A Phase 1b Study of LY573636-sodium in Combination with Sunitinib Malate in
Patients with Metastatic Renal Cell Cancer (JZAI)
Brain/ Esophageal
A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial Of Memantine For Prevention Of Cognitive Dysfunction In Patients Receiving Whole-Brain Radiotherapy
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Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma
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Phase III Trial Evaluating The Addition Of Cetuximab To Paclitaxel, Cisplatin, And Radiation For Patients With Esophageal Cancer Who Are Treated Without Surgery
Liver
Global Investigation of therapeutic DEcisions in hepatocellular carcinoma and of its treatment with SorafeNib (GIDEON)
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A Randomized Discontinuation Study of XL184 in Subjects with Advanced Solid Tumors: up to 1 prior standard tx – Liver- dx by core biopsy or CT/MRI including angiography and serum level AFP > 400 ng/mL in subjects with liver cirrhosis and/or chronic viral hepatitis B or C infection
Hematology
A phase III, open label, randomized, multicenter trial of Ofatumumab added to Chlorambucil vs. Chlorambucil Monotherapy in previously untreated patients with Chronic Lymphocytic Leukemia
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An open-label, single-arm phase II study of RAD001 in patients with refractory mantle cell lymphoma
Melanoma/Ovarian
A Randomized Discontinuation Study of XL184 in Subjects with Advanced Solid Tumors: Epithelial ovarian cancer, primary peritoneal or fallopian tube carcinoma- up to 2 or 3 prior standard tx Melanoma-cutaneous, mucosal or uveal melanoma- up to 2 prior standard tx – HOLD
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A Phase III Trial of Pelvic Radiation Therapy versus Vaginal Cuff Brachytherapy Followed By Paclitaxel/Carboplatin In Patients With High-Risk, Early Stage Endometrial Cancer -Gog 0249-
Phase I
A Phase I Open Label, Multicenter, Dose-Escalation Study to Determine the Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT), Safety and Pharmacokinetics of PG-11047 when Used in Individual Combinations with 1) Gemcitabine or 2) Docetaxel or 3) Bevacizumab or 4) Erlotinib or 5) Cisplatin or 6) 5-Flurouracil or 7) Sunitinib in Patients with Advanced Solid Tumors or Lymphoma
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A Phase 1b, Multicenter, Dose-Escalation Study of LY573636-sodium in combination with 1) Gemcitabine HCl, 2) Docetaxel, 3) Temozolomide, 4) Cisplatin in Pts with Advanced Solid Tumors
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A Phase 1b Study of LY573636-sodium in Combination with Sunitinib Malate in Patients with Metastatic Renal Cell Cancer (JZAI)
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A Phase 1b/2, Open Label, Randomized Study of Sorafenib With or Without BIIB022 in Subjects With Advanced Hepatocellular Carcinoma
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Phase 1, Multicenter, Open-Label, Single-Arm, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, a Fully Human Monoclonal Antibody Directed Against Platelet-Derived Growth Factor Receptor-alpha (PDGFR-alpha), in Subjects with Advanced Solid Tumors Refractory to Standard Therapy or for Which No Standard Therapy Exists (breast, NSCLC, HCC, Prostate or ovarian cancer – An open label Phase II trial of BIBW 2992 in genetically pre-screened cancers with EGFR and/or HER2 gene amplifications or EGFR activating mutations :a) Gastric, GEJ or Esophageal Ca b) Billiary or GallBladder cancer, c) Transitional cell cancer of bladder,d) Gynecological cancers
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A Phase I Safety Study of LY2787106 in Patients with Cancer and Anemia
Radiation/RTOG
Randomized, phase III, open-label study of oral topotecan plus whole-brain radiation tx(WBRT) compared with WBRT alone in patients with brain metastases
from Non-Small Cell Lung Cancer
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Randomized Phase III comparison of standard- dose (60 gy) versus highdose (74 gy) conformal radiotherapy with concurrent and consolidation carboplatin/paclitaxel in patients with stage IIIa/IIIb non-small cell lung cancer
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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
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A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial Of Memantine For Prevention Of Cognitive Dysfunction In Patients Receiving Whole-Brain Radiotherapy
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Phase III Trial Evaluating The Addition Of Cetuximab To Paclitaxel, Cisplatin, And Radiation For Patients With Esophageal Cancer Who Are Treated Without Surgery
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Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma
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A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer (RTOG
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A Phase III Clinical Trial Comparing Trastuzumab Given Concurently with Radiation and Radiation Alone for Women with Her2-Postive DCIS Resected by Lumpectomy
Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer RTOG 0815
STAR (Selective Trial for Accelerated Rollout)
A randomized, multi-center phase III study to evaluate the efficacy and safety of nilotinib versus imatinib in patients with unresectable or metastatic gastrointestinal stromal tumors (GIST)
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An open-label, single-arm phase II study of RAD001 in patients with refractory mantle cell lymphoma – Phase II Study of Oral PHA-848125AC in Patients with Thymic Carcinoma Previously Treated with Chemotherapy (CDKO-125a-006)
These protocols are available through Central Indiana Cancer Centers and supported by the Indiana Cancer Research Foundation. (ICRF). For more information on how you can support ICRF and the research done in Central Indiana please contact Tony Ricchiuto at 317-250-7443.