Contact Information
Northwest CCOP:
Karyn Hart
253-403-2394
karyn.hart@multicare.org
MultiCare Research Services:
Richard Shine, PharmD, BCPS
253-403-7250
richard.shine@multicare.org
Diane Miller, RN
253-403-5265
Diane.Miller@multicare.org
Cancer Research Protocols
ANTIEMETIC
URCC 1105
(07-018)
Prevention of Delayed Nausea - A Phase III Double-Blind Placebo-Controlled Clinical Trail.
NCI Provided Drug: Kytril, Aloxi, Decadron
BLADDER
CTSU R0524
(08-25)
A phase I/II trial of combination of Paclitaxel and Trastuzumab with daily irradiation or Paclitaxel alone with daily irradiation following transurethral surgery for non-cystectomy candidates with muscle-invasive bladder cancer.
NCI Provided Drug: Trastuzumab
CIRB S0337
(08-26)
A Phase III Blinded Study of Immediate Post-TURBT Instillation of Gemcitabine versus Saline in Patients with Newly Diagnosed or Occasionally Recurring Grade I/II Superficial Bladder Cancer.
NCI Provided Drug: Gemcitabine/Saline
BRAIN
CIRB N0574
Phase III Randomized Trial of the Role of Whole Brain Radiation Therapy in Addition to Radiosurgery in Patients with One to Three Cerebral Metastases.
BREAKTHROUGH CANCER PAIN
Insys Therapeutries, Inc
Open-label Multi-center Safety Trial of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breackthrough Cancer Pain.
NCI Provided Drug: Fentanyl SL Spray
Notes:
Contact:
Diane Miller
Certified Clinical Research Coordinator
253-403-5265
Pager:1-877-515-8408
BREAST - DCIS
CIRB NSABP B-43
A Phase III Clinical Trial Comparing Trastuzumab given Concurrently with Radiation Thearpy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In situ Resected by Lumpectomy.
NCI Provided Drug: Trastuzumab
| Initial IRB | IRB Renewal |
| 1/5/2009 | 10/14/2010 |
| Consent Form | Closed |
| 10/15/2009 | - |
BREAST - ER-PR Positive
CIRB NSABP B-42
(05-045)
Clinical trial to determine the efficacy of five years of Letrozole compared to placeboin patients completing five years of hormonal therapy consisting of an aromatase inhibitor (AI) or tamoxifen followed by an AI in prolonging disease free survivalin postmenopausal women with hormone receptor positive beast cancer.
NCI Provided Drug: Letrozole
Notes:
Optional Registration Program CLOSED 9/5/08
BREAST - Metastatic
LPT111111
LPT111111-----A Phase II, single-arm, multicenter study to evaluate the combination of weekly Nanoparticle Albumin-bound Paclitaxel (nab-Paclitaxel or Abraxane) and Lapatinib (Tykerb) in women who have received no more that one prior chemotherapeutic regimen in the treatmetn of ErbB2 overexpressing metastatic breast cancer.
NCI Provided Drug: Abraxane and Tykerb are both provided by GSK
Notes:
Contact:
Diane Miller
Certified Clinical Research Coordinator
253-403-5265
Pager:1-877-515-8408
S0500
(07-005)
A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients who have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment.
NCI Provided Drug: CellSearch CTC, CA 15-3, and CEA blood tests provided
S0622
(07-017)
Phase II Studies of Two Different Schedules of Dasatinib (NSAC-732517) in Bone-Metastasis Predomenant Metastatic Breast Cancer.
NCI Provided Drug: Dasatinib
BREAST - Node Negative
CTSU PCCT-1
(05-037)
CTSU PACCT-1: Program for the Assessment of Clinical Cancer Tests Trial Assigning IndividuaLized Options for Treatment: TheTAILORx Trial
BREAST - Node Positive or Negative
CTSU 40101
(20-327)
Cyclophosphamide and Doxorubicin versus paclitaxel as adjuvant therapy for women with node-negative breast cancer: A 2 x 2 factorial phase III randomized study.
NCI Provided Drug: NONE
CIRB S0221
(20-442)
Phase III trial of continuous schedule AC + G vs. Q 2 week schedule AC, followed by Paclitaxel given either every 2 weeks or weekly for 12 weeks as post-operative adjuvant therapy in node-positive or high risk node-negative breast cancer.
NCI Provided Drug: FILGRASTIM (AMGEN)
Notes:
PROTOCOL IN BEACON
CIRB S0307
(05-047)
Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer.
NCI Provided Drug: zoledronic acid, Clodronate & Idbandronate
Notes:
PROTOCOL IN BEACON
NSABP B-42
(05-045)
NSABP B-42: A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Cancer.
NCI Provided Drug: Letrozole
Notes:
Optional Registration Program Closed 9/5/08
CIRB CTSU E5103
(08-02)
A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide Followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer
NCI Provided Drug: Bevacizumab
Notes:
Suspended 9/24/09
BREAST -Other
CIRB C40601
Randomized Phase III Trial of Paclitaxel Combined with Trastuzumab, Lapalinib or both as Neoadjuvant Treatment of HER-2 Positive Primary Breast Cancer.
CTSU C70604
A Randomized, Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer.
CIRB NSABP B-40
(007-009)
A Randomized Phase IIITrial of Neoadjuvant Therapy to Ptients with Palpable and Operable Breast cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel when Administered Before ACwith or without Bevacizumab and Correlative Science Studies Attempting to Identify Predicors of High Likelihood for pCR with each of the Regimens.
NCI Provided Drug: Capecitabine, Gemcitabine and Bevacizumab
CTSU N063D ALTTO
(08-12)
A Randomized, Multi-Center, Open Label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, their Sequence and their Conbinationin Patients with HER2/ErbB2 Positive Primary Breast Cancer. ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Studty.
NCI Provided Drug: Lapatinib...if insurance does not cover Trastuzumab, it will be provided
Notes:
Dosing 1 closed 3/15/09
ON HOLD until Amend #4 approved (Jan meeting)
BREAST-Pre Menopausal
CTSU IBCSG 24-02
((05-021))
Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane Adjuvant Therapies for Premenopausal women with Endocrine Responsive Brast Cancer (SOFT Trial)
NCI Provided Drug: Exemestane, Triptorelin
Cancer Related Fatigue
URCC 08106
A Study of the Effects of Exercise on Cancer-Related Fatigue
DYSPNEA
URCC 1701
(20-296)
Dyspnea in cancer patients
NCI Provided Drug: BUSPIRONE HYDROCHLORIDE
GASTROINTESTINAL - Colon
CIRB CTSU N0147
(20-455)
A randomized phase III trial of Oxaliplatin (OXAL) plus 5 FU/Leucovorin with/without Cetuximab after curative resection for patients with stage III colon cancer.
NCI Provided Drug: OXALIPLATIN-LOPERAMIDE-CETUXIMAB
Notes:
PROTOCOL IN BEACON
CIRB CTSU E5202
(05-050)
A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers.
NCI Provided Drug: Bevacizumab, Oxaliplatin
Notes:
Re-Opened
PROTOCOL IN BEACON
CIRB S0600
(8-16)
Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab with or without Bevacizumab as Second-Line Thearpy for Patients with Metastatic Colorectal Cancer who have Progressed on Bevacizumab with either FOLFOX, OPTIMOX or XELOX.
NCI Provided Drug: Bevacizumab, Cetuximab
Notes:
Re-Activated 10-15-09
GASTROINTESTINAL - Colorectal
CIRB C80405
(05-022)
A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab (C-25) or with the Combination of Bevacizumab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum.
NCI Provided Drug: Cetuximab
Notes:
QOL CLOSED 8/31/07
PROTOCOL IN BEACON
GASTROINTESTINAL - Rectal
CIRB R-04
(20-486)
Clinical Trial Comparing Preopertive RadiationThearpy and Capecitabine with or without Oxaliplatin with Preoperative Radiation Therapy and Continuous Intravenous Infusion of 5-FU with or without Oxaliplatin in the Treatment of Patients with Operable Carcinoma of the Rectum.
NCI Provided Drug: Capecitabine-Oxaliplatin-Ganisetron (Kytril
Notes:
PROTOCOL IN BEACON
GENITOURINARY - Prostate
CIRB R0232
A Phase III Study Comparing Combined External Beam Radiation and Transperineal Intersperineal Interstitial Permanent Brachytherapy with Brachytheapy alone for Selected Patients with Intermediate Risk Prostatic Carcinoma.
Notes:
XRT ONLY
CIRB R0534
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.
Notes:
XRT ONLY
CIRB C90203
Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer.
NCI Provided Drug: Docetaxel
CURC 0601
Multicenter, double-blind study comparing 0.5mg dutasteride vs. placebo daily in men receiving intermittent androgen ablation therapy for prostate cancer.
NCI Provided Drug: Dutasteride/placebo
Notes:
Contact:
Diane Miller
Certified Clinical Research Coordinator
253-403-5265
Pager:1-877-515-8408
| Initial IRB | IRB Renewal |
| - | - |
| Consent Form | Closed |
| - | - |
SWOG 0000A
(20-297A, 20-297B)
SWOG 0000A: Prevention of Alzheimer’s Disease Vitamin E and Selenium Trial (PREADVISE), Secondary Consent Form – Medical Evaluation for Possible Memory Problems.
CIRB S0421
(08-19)
Phase III Study of Doxcetaxel and Atrasentan versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer.
NCI Provided Drug: Atrasentan
GENITOURINARY - Renal
CTSU E2805
(08-03)
Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
NCI Provided Drug: Sorafenib, placebo, Sunitinib
GYNECOLOGIC-CERVICAL
CIRB GOG 0219
A Phase III, Randomized Trial of Weekly Cisplatin and Radiation versus Cisplatin and Tirapazamine and Radiation in State IIB2, IIB, IIIB and IVA Cervical Carcinoma Limted to the Pelvis.
NCI Provided Drug: Tirapazamine
Notes:
Temp. Closed 9/1/09
HEAD & NECK
OS13602
Multicenter randomized phase II study of Erlotinib, Cisplatin and radiotherapy in patients with stage III and IV squamous cell carcinoma of the head and neck.
NCI Provided Drug: Erlotinib
Notes:
Contact:
Diane Miller
Certified Clinical Research Coordinator
253-403-5265
Pager:1-877-515-8408
LEUKEMIA
CIRB S9007
(91-060)
Cytogenetic studies in leukemia patients.
NCI Provided Drug: None
CIRB SWOG 9910
(20-248)
Leukemia centralized reference laboratories and tissue repositories.
NCI Provided Drug: None
CIRB CTSU C10501
A Phase III Intergroup CLL Study of Asymptomatic Patients with Untreated Chronic Lymphocytic Leukemia Patients Randomized to Early Intervention versus Observation with later Treatment in the High risk Genetic Subset with IbVh Unmutated Disease.
NCI Provided Drug: Genentech/BiogenIdec will supply Rituximab
LUNG - Non-Small Cell
AC01L08
A Multi-Center Randomized Phase 2b Study of Cetuximab in combination with Platinum-Based Chemotherapy as First Line Treatment of patients with Recurrent or Advanced Non-Small Cell Lung Cancer.
Notes:
Please contact:
Diane Miller, RN
253-403-5265 (24 hours)
Cetuximab provided
CIRB S0819
A Randomized Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitasel/Bevacizumab with or without concurren tCetuximab in patiens with advanced non-small cell lung cancer.
Notes:
Cetuximab
CASA0404A2302
A Study of ASA404 or Placebo in Combination with Docetaxel in Second-Line Treatment for (Stage IIIb/IV) Non-Small Lung Cancer (ATTRACT-2)
NCI Provided Drug: ASA404/Placebo
Notes:
Contact:
Diane Miller
Certified Clinical Research Coordinator
253-403-5265
Pager:1-877-515-8408
| Initial IRB | IRB Renewal |
| - | - |
| Consent Form | Closed |
| - | - |
PSOC 6137p
A phase Ii study of intermittent GLEEVE (Imatinib) and weekly Paclitaxelin patients aged 70 or older with advanced NSLLC.
Notes:
Contact:
Diane Miller
Certified Clinical Research Coordinator
253-403-5265
Pager:1-877-515-8408
| Initial IRB | IRB Renewal |
| - | - |
| Consent Form | Closed |
| - | - |
S0424
(05-018)
Molecular Epidemiology Case-Series Study of Non-Small Cell Lung Cancer in Smoking and Non-Smoking Women and Men.
NCI Provided Drug: None
Notes:
TEMP CLOSURE (FEMALE/MALE SMOKING STRATA)
S0533
(08-07)
A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSG-704865) in three Cohorts of Patients with Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer.
NCI Provided Drug: Bevacizumab
CTSU E1505
(08-05)
A Phase III Randomized Trial of Adjuvant chemotherapy with or without Bevacizumab for Patients with Completely Resected Stage IB (>4 cm) IIIA Non-Small Lung Cancer.
NCI Provided Drug: Bevacizumab
LUNG - Small Cell
CIRB S9925
(20-220)
Lung cancer specimen repository protocol, ancillary.
| Initial IRB | IRB Renewal |
| - | 3/10/2010 |
| Consent Form | Closed |
| - | - |
LYMPHOCYTIC LEUKEMIA
PSOC 2301
A Phase II Study of Bexxar Consolidation in Patients with B-Cell Chronic Lymphocytic Leukemia Following Fludarabine and Rituximab Chemotherapy.
NCI Provided Drug: BEXXAR
Notes:
Contact:
Diane Miller
Certified Clinical Research Coordinator
253-403-5265
Pager:1-877-515-8408
| Initial IRB | IRB Renewal |
| - | - |
| Consent Form | Closed |
| - | - |
LYMPHOMA-Ancillary-Repository Protocols
SWOG 8819
(88-066A)
Central lymphoma repository tissue procurement protocol, ancillary.
| Initial IRB | IRB Renewal |
| - | 10/6/2008 |
| Consent Form | Closed |
| - | - |
SWOG 8947
(90-031)
Central lymphoma repository protocol
NCI Provided Drug: None
LYMPHOMA-DLBCL
CIRB C50303
(8-14)
Phase III Randomized Study of R-CHOP v Dose-Adjusted Epoch-R with Molecular Profiling in Untreated De Novo Diffuse Large B-Cell Lymphomas.
LYMPHOMA-Hodgkins/Non-Hodgkins
PSOC 2302
A Phase I/II Study of Vorinostat plus Rituximab, Ifosphamide, Carboplatin, and Etoposide for Patients with Relapsed or Refractory Lymphoid Malignancies
NCI Provided Drug: Vorinostat
Notes:
Contact:
Diane Miller
Certified Clinical Research Coordinator
253-403-5265
Pager:1-877-515-8408
| Initial IRB | IRB Renewal |
| - | - |
| Consent Form | Closed |
| - | - |
MELANOMA
Bristol-Myers Squibb CA184045
A multicenter treatment protocol for compassionate use of Ipilimumab (BMS 734016) Monotherapy in subjects withunresectable stage III or IV melanoma. (Must have failed at least one prior systemic treatment )
NCI Provided Drug: Ipilimumab
Notes:
TEMP CLOSED TO ENROLLMENT
Contact:
Diane Miller
Certified Clinical Research Coordinator
253-403-5265
Pager:1-877-515-8408
| Initial IRB | IRB Renewal |
| - | - |
| Consent Form | Closed |
| - | - |
MYELOMA
CTSU E1A06
(08-15)
An intergroup phase III randomized controlled trial comparing Melphalan, Prednisone and Thalidomide (MPT) versus Melphalan, Prednisone and Lenalidomide (Revlimid) (MPR) in newly diagnosed Multiple Myeloma patient swho are not candidates for high-dose therapy.
NCI Provided Drug: Thalidomide/Lenalidomide
SWOG 0309
(No Consent)
Myeloma Specimen Repository Protocol Ancillary.
NCI Provided Drug: ANCILLARY STUDY
| Initial IRB | IRB Renewal |
| 10/13/2004 | 3/5/2010 |
| Consent Form | Closed |
| - | - |
NEOADJUVANT
CIRB C40601
Randomized Phase III Trial of Paclitaxel combined with Trastuzumab, Lapalinib or both as Neoadjuvant Treatment of HER-2 Positive Primary Breast Cancer.
NEUROPATHY
S0715
Randomized Placebo-Controlled Trial of Acetyl L Carnitine for the Prevention of Taxane induced Neuropathy.
NCI Provided Drug: ALC/Placebo
URCC 07004
Assessment of Topical Treatment Response with Amitriptyline and Ketamine: Combination Trial in Chemotherapy Peripheral Neuropathy.
Notes:
Amitriptyline/Ketamine
OSTEONECROSIS OF THE JAW
SWOG 0702
A prospective observational Multicenter Cohort Study to Assess the Incident of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment
STRESS
HLMCC 05-01
(07-001)
Stress Management therapy for Patients Undergoing Chemotherapy.