MultiCare Health System


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

Categories:

ANTIEMETIC

URCC 1105

(07-018)

Prevention of Delayed Nausea - A Phase III Double-Blind Placebo-Controlled Clinical Trail.

NCI Provided Drug: Kytril, Aloxi, Decadron

Initial IRB IRB Renewal
8/6/2007 8/3/2009
Consent Form Closed
8/3/2009 -

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

Initial IRB IRB Renewal
11/3/2008 11/2/2009
Consent Form Closed
11/2/2009 -

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

Initial IRB IRB Renewal
- 3/5/2010
Consent Form Closed
12/30/2008 -

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.

Initial IRB IRB Renewal
- 4/19/2010
Consent Form Closed
8/6/2008 -

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

Initial IRB IRB Renewal
- -
Consent Form Closed
- -

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

Initial IRB IRB Renewal
- 6/3/2010
Consent Form Closed
1/23/2009 -

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

Initial IRB IRB Renewal
- -
Consent Form Closed
- -

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

Initial IRB IRB Renewal
3/5/2007 8/5/2010
Consent Form Closed
6/1/2009 -

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

Initial IRB IRB Renewal
8/6/2007 8/11/2008
Consent Form Closed
5/4/2009 -

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

Initial IRB IRB Renewal
11/11/2008 4/2/2010
Consent Form Closed
3/18/2009 -

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

Initial IRB IRB Renewal
10/8/2003 2/22/2010
Consent Form Closed
6/23/2008 -

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

Initial IRB IRB Renewal
11/6/2008 5/20/2010
Consent Form Closed
1/1/2008 -

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

Initial IRB IRB Renewal
9/17/2008 1/25/2010
Consent Form Closed
7/13/2009 -

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

Initial IRB IRB Renewal
6/11/2006 6/3/2010
Consent Form Closed
1/23/2009 -

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

Initial IRB IRB Renewal
1/7/2008 9/30/2010
Consent Form Closed
7/16/2009 -

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.

Initial IRB IRB Renewal
- 6/17/2010
Consent Form Closed
9/2/2009 -

CTSU C70604

A Randomized, Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer.

Initial IRB IRB Renewal
5/4/2009 -
Consent Form Closed
5/4/2009 -

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

Initial IRB IRB Renewal
9/10/2008 7/15/2010
Consent Form Closed
7/15/2010 -

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)

Initial IRB IRB Renewal
4/7/2008 6/1/2009
Consent Form Closed
6/1/2009 -

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

Initial IRB IRB Renewal
5/23/2007 9/14/2009
Consent Form Closed
9/14/2009 -

Cancer Related Fatigue

URCC 08106

A Study of the Effects of Exercise on Cancer-Related Fatigue

Initial IRB IRB Renewal
11/2/2009 -
Consent Form Closed
- -

DYSPNEA

URCC 1701

(20-296)

Dyspnea in cancer patients

NCI Provided Drug: BUSPIRONE HYDROCHLORIDE

Initial IRB IRB Renewal
4/9/2003 8/3/2009
Consent Form Closed
8/3/2009 -

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

Initial IRB IRB Renewal
10/7/2008 2/22/2010
Consent Form Closed
4/21/2009 -

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

Initial IRB IRB Renewal
9/12/2008 9/2/2010
Consent Form Closed
7/29/2009 -

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

Initial IRB IRB Renewal
5/5/2008 1/25/2010
Consent Form Closed
4/10/2008 -

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

Initial IRB IRB Renewal
1/9/2006 6/3/2010
Consent Form Closed
8/17/2009 -

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

Initial IRB IRB Renewal
4/2/2007 9/2/2010
Consent Form Closed
3/25/2009 -

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

Initial IRB IRB Renewal
- 7/1/2010
Consent Form Closed
1/11/2008 -

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

Initial IRB IRB Renewal
11/7/2008 1/8/2009
Consent Form Closed
3/15/2010 -

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

Initial IRB IRB Renewal
11/7/2008 3/15/2010
Consent Form Closed
7/17/2008 -

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.

Initial IRB IRB Renewal
4/9/2003 8/11/2008
Consent Form Closed
8/11/2008 -

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

Initial IRB IRB Renewal
6/2/2008 6/17/2010
Consent Form Closed
6/8/2009 -

GENITOURINARY - Renal

CTSU E2805

(08-03)

Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma

NCI Provided Drug: Sorafenib, placebo, Sunitinib

Initial IRB IRB Renewal
1/7/2008 3/15/2010
Consent Form Closed
9/2/2009 -

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

Initial IRB IRB Renewal
- 5/6/2010
Consent Form Closed
6/5/2009 -

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

Initial IRB IRB Renewal
- -
Consent Form Closed
- -

LEUKEMIA

CIRB S9007

(91-060)

Cytogenetic studies in leukemia patients.

NCI Provided Drug: None

Initial IRB IRB Renewal
- 5/19/2009
Consent Form Closed
6/23/2008 -

CIRB SWOG 9910

(20-248)

Leukemia centralized reference laboratories and tissue repositories.

NCI Provided Drug: None

Initial IRB IRB Renewal
2/13/2002 3/5/2010
Consent Form Closed
5/26/2009 -

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

Initial IRB IRB Renewal
- 9/30/2010
Consent Form Closed
12/10/2008 -

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

Initial IRB IRB Renewal
- -
Consent Form Closed
- -

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

Initial IRB IRB Renewal
- 7/15/2010
Consent Form Closed
7/29/2009 -

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)

Initial IRB IRB Renewal
11/7/2005 8/3/2009
Consent Form Closed
8/3/2009 -

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

Initial IRB IRB Renewal
3/3/2008 11/2/2009
Consent Form Closed
11/2/2009 -

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

Initial IRB IRB Renewal
3/3/2008 4/2/2010
Consent Form Closed
2/18/2009 -

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

Initial IRB IRB Renewal
6/13/1990 10/6/2008
Consent Form Closed
10/6/2008 -

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.

Initial IRB IRB Renewal
5/5/2008 4/2/2010
Consent Form Closed
2/10/2009 -

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

Initial IRB IRB Renewal
5/5/2008 1/25/2010
Consent Form Closed
9/3/2009 -

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.

Initial IRB IRB Renewal
- 9/9/2009
Consent Form Closed
9/29/2008 -

NEUROPATHY

S0715

Randomized Placebo-Controlled Trial of Acetyl L Carnitine for the Prevention of Taxane induced Neuropathy.

NCI Provided Drug: ALC/Placebo

Initial IRB IRB Renewal
11/2/2009 -
Consent Form Closed
- -

URCC 07004

Assessment of Topical Treatment Response with Amitriptyline and Ketamine: Combination Trial in Chemotherapy Peripheral Neuropathy.

Notes:

Amitriptyline/Ketamine

Initial IRB IRB Renewal
3/2/2009 3/2/2009
Consent Form Closed
- -

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

Initial IRB IRB Renewal
5/4/2009 -
Consent Form Closed
11/2/2009 -

STRESS

HLMCC 05-01

(07-001)

Stress Management therapy for Patients Undergoing Chemotherapy.

Initial IRB IRB Renewal
1/8/2007 10/6/2008
Consent Form Closed
10/6/2008 -