CURRENT CANCER STUDIES OPEN TO PATIENTS ENROLLMENT

HEAD & NECK CANCER

**Christine LaMarre, D.D.S. Bowman-Birk Inhibitor Concentrate and Oral
Leukoplakia**

This project involves studying the effects of the investigational drug,
Bowman-Birk Inhibitor (BBIC), as a prevention therapy for cancer of the
mouth and tongue. The study is to determine whether BBIC, a protease
inhibitor extracted from soybeans, can reduce intermediate marker
endpoints in buccal mucosal cells in patients with oral leukoplakia,
ultimately offering a protective effect against cancer formation.

# LUNG CANCER

**Samar Azawi, M.D. A Phase III Comparison of Prophylactic Cranial
Irradiation versus Observation in Patients with Locally Advanced
Non-Small Cell Lung Cancer**

> The primary objective of this clinical trial is to help improve the
> overall health and survival of patients with lung cancer. Fifty
> percent of patients with locally advanced non-small cell lung cancer
> will develop brain metastases during the course of their disease. We
> want to use prophylactic cranial irradiation to decrease the incidence
> of brain metastases.

**Samar Azawi, M.D. Phase III Chemoprevention Trial of Selenium
Supplementation in Persons with Resected Stage I Non-Small Cell Lung
Cancer**

The objective of this clinical trial is to evaluate the efficacy of
selenium supplementation in reducing the incidence of second primary
lung tumors in patients who have been treated for Stage I non-small cell
lung cancer who underwent complete surgical resection.

Samar Azawi, M.D. A Phase II, Randomized Trial using Captopril in
Patients Who Have Received Radiation Therapy + Chemotherapy for Stage
II-IIIB Non-small Cell Lung Cancer (NCLC), Stage I Central NCLC or
Limited-stage

> The primary objective of this clinical trial is to test the ability of
> Captopril to alter the incidence of pulmonary damage after radiation
> treatment in a group of patients who completed radiotherapy to the
> lung.

# CANCER OF THE DIGESTIVE SYSTEM

**Padmini R. Iyer, M.D. A Phase III Randomized Controlled Study
Comparing the Survival of Patients with Unresectable Hepatocellular
Carcinoma (HCC) Treated With THYMITAQ to Patients Treated With
Doxorubicin**

An open label randomized study for patients with unresectable
hepatocellular carcinoma comparing treatment with doxorubicin vs
Thymitaq.

**M. Mazen Jamal, M.D. A Phase 3, Multicenter, Single-Blind, Randomized
Study of XL119 Versus 5-Fluorouracil (5-FU) plus Leucovorin (LV) in
Patients with Advanced Biliary Tumors not Amenable to Conventional
Surgery**

Currently there is no proven effective treatment for patients with
gallbladder or biliary cancer who are not amenable to surgery. This
study is to compare a new chemotherapeutic agent that has high
concentration in bile with traditional chemotherapy in prolonging
survival.

**Jayashri Kidao, M.D. Difluoromethylornithine ( DFMO) plus Sulindac to
Decrease the Rate of Recurrence of Adenomatous Polyps of the Colon**

The overall goal of this study is to develop an effective and safe
therapy that will prevent colon cancer. This 36 month , NCI sponsored
study, examines the feasibility of using two safe drugs, low dose
Sulindac in combination with low dose difluoromethylornithine (DFMO), to
prevent the recurrence of adenomatous colon polyps and thereby
presumably reduce the risk of cancer.

[PROSTATE]{.underline}

Samar Azawi, M.D. A Phase III Randomized Study of High Dose 3D-CRT/IMRT
versus Standard Dose 3D-CRT/IMRT in Patients Treated for Localized
Prostate Cancer

The primary objective of this clinical trial is to determine whether a
higher dose of 7900 cGy 3-Dimensional Conformal Radiotherapy (3D-CRT)
will result in improved overall survival in patients treated for
prostate cancer as compared to patients treated with a standard dose of
7000 cGy 3D-CRT.

**Padmini R. Iyer, M.D. Early Stage Prostate Cancer Cohort**

An observational study involving the collection of demographic,
lifestyle, and medical data on a cohort of veterans with early stage
prostate cancer and the establishment of a repository of frozen blood
samples from the same cohort of patients to explore factors that could
be associated with the transformation to clinically aggressive cancer.
The study involves yearly follow-up surveys and a collection of a blood
sample every other year.

**Padmini R. Iyer, M.D. A Randomized, Double-Blind, Placebo Controlled,
Trial of Intravenous Zoledronic Acid to Prevent Osteoporosis in Men
Undergoing Androgen Deprivation (ADT) Therapy in VA Population**

A double-blind randomized study comparing the effect of zoledronic acid
(Zometa®) to placebo in the prevention of osteoporosis in VA patients
receiving ADT for prostate cancer. Study patients receive their study
treatment along with their hormone treatment over a period of one year
and have a DEXA scan at baseline and at 6 and 12 months in the study.

**Padmini R. Iyer, M.D. The Use of Zoledronic Acid in Men on Androgen
Deprivation Therapy (ADT) for Prostate Cancer with Pre-existing
Osteoporosis**

An open label study on VA patients receiving ADT for prostate cancer and
found to have osteoporosis on their initial DEXA scan. Study patients
receive zoledronic acid (Zometa®) infusion along with their ADT over a
period of one year and have a DEXA scan at 6 and 12 months.

**Padmini R. Iyer, M.D. ACTIVE Health Cohort Study**

The Aging Cohort to Improve Veterans Health, a multi racial
observational cohort of relatively healthy veterans over the age of 50
to explore racial differences in lifestyle, biochemical, and genetic
predictors of prostate cancer and other chronic diseases such as stroke
and hypertension. The study involves annual follow-up surveys and
collection of a baseline blood sample.

**For more information, please contact:**

Research & Development Office (09/151)

VA Long Beach Healthcare System

5901 E. Seventh Street, Long Beach, CA 90822

\(562\) 825-5801