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Clinical Research Newsletter
Monmouth Medical Center Approved Adult Oncology Clinical Trials
Volume 6 Spring 2004
This Newsletter is Published by the Research Office of the Department of Academic Affairs
Joseph Jaeger, Associate Vice President of Academic Affairs
Joanne MacFie, RN, Clinical Research Coordinator
Catherine Weber, RN, BSN, Trial Coordinator

INTRODUCTION
Clinical Trial Newsletter is a quarterly update of the adult clinical oncology trials approved at Monmouth Medical Center. This newsletter is designed to give you information regarding available clinical trials. With this information, you will be able to provide your patients with the most state-of-the-art care. It will also include updates from sponsors and data summaries from cooperative groups as the information becomes available.


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RESEARCH DEPARTMENT
WE HAVE MOVED TO A NEW LOCATION
The research office is now located in SH214 and can be reached by calling 732-923-7689. Please join us in welcoming Carol Mainieri who has accepted the research assistant position. Please feel free to contact us regarding the research program or specific clinical trials.


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HIGHLIGHT New Trials Approved
Monmouth Medical Center Institutional Review Board has granted approval for the following clinical trials:


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Department of Radiation Oncology
RTOG 0123
A Phase II Randomized Trial with Captopril in patients who have received Radiation Therapy +/- Chemotherapy For Stage II-IIIB NSCLC, Stage I Central NSCLC, or Limited Stage Small cell lung cancer.

RTOG 0315
A Randomized, Double Blind, Placebo-Controlled Phase III Study to Determine the Efficacy of Sandostatin Laro® Depot (OCTREOTIDE ACETATE) in Preventing or Reducing the Severity of Chemoradiation-Induced Diarrhea in Patients with Anal or Rectal Cancer

RTOG 0324:
A Phase II Study Of Cetuximab (C225) in Combination with Chemoradiation in Patients with Stage IIIA/B Non-Small Cell Lung cancer

MedImmune
Open Label, Multicenter trial of Amifostine in the Prevention of radiation Induced Esophagitis and Pneumonitis in patients with Measurable, Non-resectable Non Small Cell Lung Cancer

Medical Oncology
CINJOG
Phase II Study of Weekly Docetaxel Together With Weekly Cisplatin in Chemotherapy Naïve Patients With Stage IV or Select Stage IIIB (Malignant Effusion) Non-Small Cell Lung Cancer

NSABP B36
A Clinical Trial of Adjuvant Therapy Comparing Six Cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophosphamide (AC), With or Without Celecoxib, in Patients with Node-Negative Breast Cancer


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TRIALS CURRENTLY OPEN TO ACCRUAL AT MMC

BREAST
MMC Partial Breast Radiation Therapy Delivered Via High Dose Rate Brachytherapy and Mammosite™ Device
MMC A Pilot Study of Limited Field Intensity Modulated Radiotherapy in the Management of Early Stage Breast Cancer
RTOG 9804 Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus RT for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast Patient
NSABP-31A Randomized Trial Comparing The Safety and Efficacy of Adriamycin and Cytoxan Followed by Taxol (AC-T) To That of Adriamycin and Cytoxan Followed by Taxol Plus Herceptin (AC-T+H) in Node + Breast Cancer Patients Who Have Tumors That Over express HER2
NSABP B35

A Clinical Trial Comparing Anastrozole with Tamoxifen in Postmenopausal Patients with DCIS Undergoing Lumpectomy with radiation Therapy

NSABP B36

A Clinical Trial of Adjuvant Therapy Comparing Six Cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to Four Cycles of Adriamycin and Cyclophosphamide (AC), With or Without Celecoxib, in Patients with Node-Negative Breast Cancer

NSABP-2
Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer

John Wayne Cancer Institute/MedImmune

Amifostine as a Radioprotectant
for Breast Cancer Patients with Augmented or Reconstructed Breasts Undergoing Radiation Therapy

University of Iowa/Department of Defense

Clinical Evaluation of Digital Mammography


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LUNG

RTOG 0017A Phase I Study of Gemcitabine, Carboplatin or Gemcitabine, Paclitaxel, and Radiation Therapy Followed by Adjuvant Chemotherapy for Patients with Favorable Prognosis Inoperable Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
RTOG 0123A Phase II Randomized Trial with Captopril in patients who have received Radiation Therapy +/- Chemotherapy For Stage II-IIIB NSCLC, Stage I Central NSCLC, or Limited Stage Small cell lung cancer.
RTOG 0212A Phase I/II Randomized Trial of Two doses (PHASE III-Standard VS. High) and Two dose high schedule (PHASE II-Once VS. Twice Daily) for delivering prophylactic cranial irradiation for patients with Limited Disease Small Cell Lung Cancer
RTOG 0213 A Phase I/II Trial of a Cox-2 Inhibitor, Celebrex™ with Limited Field Radiation for Intermediate Prognosis Patients with Locally Advanced Non-Small Cell Lung Cancer, with Analysis of Prognostic Factors
RTOG 0214

A Phase III Comparison of Prophylactic Cranial Irradiation versus Observation in Patients with Locally Advanced Non-Small Cell Lung cancer

RTOG 0241Phase I Study of Irinotecan and Cisplatin combination with twice daily thoracic radiotherapy (45 Gy) or once daily thoracic radiotherapy (70 Gy) for patients with Limited Stage Small Cell Lung Cancer
MedImmuneOpen Label, Multicenter trial of Amifostine in the Prevention of radiation Induced Esophagitis and Pneumonitis in patients with Measurable, Non-resectable Non Small Cell Lung Cancer
CINJOGPhase II Study of Weekly Docetaxel Together With Weekly Cisplatin in Chemotherapy Naïve Patients With Stage IV or Select Stage IIIB (Malignant Effusion) Non-Small Cell Lung Cancer
GI
CINJ

Phase II Study of Gleevec (Imatinib Mesylate, formerly known as ST1571) in patients with metastatic unresectable pancreatic cancer

RTOG E-0113

Non-Operative Therapy of Local-Regional Carcinoma of the Esophagus: A Randomized Phase II Study of Two Paclitaxel-Based Chemo radiotherapy Regimens

RTOG S-0132

A Phase II Trial of Neo Adjuvant STI-571 (Gleevec) for Primary and Recurrent Operable Malignant GIST Expressing KIT Receptor Tyrosine Kinase (CD117)

RTOG 0246

A Phase II Study of a paclitaxel-based chemoradiotherapy regimen with selective surgical salvage for respectable loco regionally advanced carcinoma of the esophagus

RTOG 0315

A Randomized, Double Blind, Placebo-Controlled Phase III Study to Determine the Efficacy of Sandostatin Laro® Depot (OCTREOTIDE ACETATE) in Preventing or Reducing the Severity of Chemoradiation-Induced Diarrhea in Patients with Anal or Rectal Cancer

RTOG 9811

A Phase III Randomized Study of 5-FU, Mitomycin-C, and RT versus 5-FU, CDDP and RT in Carcinoma of the Anal Canal

MMC

Preoperative Chemoradiation with Celebrex for Rectal Cancer


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BLADDER
CINJ 5976

A Phase I/II Trial of Gemcitabine, Carboplatin and Taxol Combination Therapy in Patients with Advanced Malignancy and Locally Advanced Unresectable Metastatic Urothelial Cancer


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GYNECOLOGY
RTOG 0116

A Two Part Phase I/II Study of Extended Field External Irradiation and Intracavitary Brachytherapy combined with Chemotherapy (weekly Cisplatin-Arm 1) and Amifostine (weekly Cisplatin and Amifostine - Arm 2) in carcinoma of the cervix with positive para-aortic of high common iliac lymph nodes.


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HEAD AND NECK
McNeil

The ARISE study
A double blind, randomized, vehicle controlled study comparing the safety and efficacy of Benzydamine Hydrochloride 0.15% Oral Rinse

RTOG 0022

Conformal and Intensity Modulated Irradiation for Oropharyngeal Cancer

RTOG 0129

A Phase III Trail of Concurrent Radiation and Chemotherapy for Advanced Head and Neck Carcinomas

RTOG 0225

A Phase II Study of Intensity Modulated Radiation Therapy (IMRT) + 1 - Chemotherapy for Nasopharyngeal Cancer

RTOG 0324

A Phase II Study of Cetuximab (C225) in Combination with Chemoradiation in Patients with Stage IIIA/B Non-Small Cell Lung cancer

NCI 4551

A Phase I Study of ZD 1839 (Iressa) in Combination with Radiation and Chemotherapy in Locally Advanced Squamous Cell carcinoma of the Head and Neck Patients


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PROSTATE
MMC

A Prospective Evaluation of Feasibility and Validation of Intensity Modulated Radiation Therapy for Prostate Cancer at High Dose Levels

MMC

Phase I Study to Evaluate the use of Brachytherapy for Salvage of recurrent Prostate Cancer Following Definitive Treatment with External Beam Radiotherapy

RTOG 9902

A Phase II Protocol of Androgen Suppression (AS) and RT as an Rx Followed by Chemo with Paclitaxel, Estramustine, and Etoposide for Localized, High Risk, Prostate Cancer


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BRAIN
RTOG 9813

A Phase I/III Randomized Study of Radiation Therapy and Temozolomide Versus Radiation Therapy and BCNU Versus Radiation Therapy and Temozolomide and BCNU for Anaplastic Astrocytoma

RTOG 0131

A Phase II Trial of Pre Irradiation and Concurrent Temozolomide in Patients with Newly Diagnosed Anaplastic Oligodendrogliomas and Mixed Anaplastic Oligoastrocytomas

RTOG 0118

A Phase III Study of Conventional Radiation Therapy Plus Thalidomide versus Conventional Radiation therapy for Multiple Brain Metastases


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OTHER:
MMC

Study of Stereotactic Body Radiotherapy for Recurrent or Metastatic Lesions to the Lung, Liver, Spine and Viscera

NJCOC

Elderly and Clinical Radiation Trials

PROTOCOL CLOSURES:
The following trials are closed to accrual

NSABP-30

A Three Arm Randomized Trial to Compare Adjuvant Adriamycin Followed by Taxotere (AC-T); Adriamycin and Taxotere (AT); and Adriamycin, Taxotere, and Cyclophosphamide (ATC) in Breast Cancer Patients with Positive Axillary Lymph Nodes

RTOG G-0114

A Randomized Phase II Comparison of Two Cisplatin-Paclitaxel Containing Chemoradiation Regimens in Resected Gastric Cancers

RTOG 9904

A Phase II Trial of Preoperative Chemotherapy and Chemo radiotherapy for Potentially Resectable Adenocarcinoma of the Stomach

RTOG 9910

A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and RT in Intermediate Risk Prostate Cancer

RTOG P 0011

Phase III Randomized Study of Adjuvant Therapy for High Risk pT2-3 N0 Prostate Cancer

CINJ

Phase II Trial of Transdermal Estradiol in the Treatment of Hormone Refractory Prostate Cancer

RTOG 0211

A Phase I/II Study of an Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, ZD1839 (Iressa) with Radiation Therapy in Glioblastoma Multiforme


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LINKS:
NSABP

National Surgical Adjuvant Breast and Bowel Project- NIH sponsored Research
www.nsabp.pitt.edu

RTOG

Radiation Therapy Oncology Group- NIH sponsored Research
www.rtog.org

CINJOG

Cancer Institute of New Jersey Oncology Group- NIH Sponsored Research
www.cinj.org

NJSCOC

New Jersey State Commission on Cancer

Copyright © 2004 Monmouth Medical Center

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