Index of Current Clinical Trials

 Listed below are study summaries of the clinical trials SDCRI is presently supporting. (Programs for prostate cancer and brain tumors are under development).

1. Breast Cancer
2. Colorectal Cancer
3. Low Grade Non-Hodgkin's Lymphoma
4. Non-Small Cell Lung Cancer (NSCLC)
5. Prostate Cancer

Breast Cancer

1. 1. A Phase III Open Label Study Comparing 2 Standard Chemotherapy Treatments for Metastatic Breast Cancer

Target Populations
· Patients must have metastatic breast cancer
· Patients may have had 1 prior chemotherapy treatment for metastatic disease. Patient may have received adjuvant chemotherapy treatment.
· Patients must not have received prior treatment with Gemcitabine (Gemzar) or Capecitabine (Xeloda)
· Patients may have received a Taxane in the adjuvant setting but not in the metastatic setting.

Patient will be randomized to 1 of 2 standard treatment groups. This is an open-label study, therefore all patients will know which treatment group they have been assigned.

Please contact Dawn Billingsley at 760-598-1700.

2. 2. An Open-Label, Multicenter, Single Arm Phase II Study of an Oral Study Drug as Single Agent Therapy in subjects with Advanced or Metastatic Breast Cancer

Target Populations
· Patients must have refractory Stage IIIB or Stage IV breast cancer
· Patients must have anthracycline and taxane containing chemotherapy as well as capecitabine
· If patients are Her2 neu +, patients must have had prior treatment with Herceptin

Patients will who qualify for this trial will take the study drug daily in pill form. All patients on study receive the same treatment.

Please contact Dawn Billingsley at 760-598-1700

3. A Phase II study of Bi-Weekly Docetaxel as First-Line Therapy for Metastatic Breast Cancer

Target Populations:
· Patients with metastatic breast cancer that is negative for the her-2 neu gene
· Patients cannot have had prior chemotherapy for locally advanced or metastatic breast cancer. Patients who have had adjuvant chemotherapy for non-metastatic disease are allowed
· Patients with prior docetaxel treatement will not be allowed in this study

All patients will receive docetaxel every 2 weeks as stipulated by the protocol.

Please contact Christine DeFrancisco at 760-598-1700.

4. A Study Measuring the Anti-nausea Properties of Acupressure

Target Populations:
· Patients must have breast cancer and receiving chemotherapy containing adriamyacin
· Patients must have at least 2 cycles of chemotherapy left
· Patients must have experienced nausea during the first or second cycle of chemotherapy.

Patient will be grouped into 1 of 3 study groups. The first is a control group who will not use acupressure to help with their nausea. A second group will be taught a placebo pressure point while the third group will be taught the pressure point thought to help relieve nausea. All 3 groups will continue there standard treatment for nausea control.

Please contact Dawn Billingsley at 760-598-1700.

5. A survey study for sisters with breast cancer

Target Populations:
· Patients and their Sisters who have been diagnosed with invasive breast cancer

Patients will be asked to donate blood and complete a survey regarding their breast cancer history. The patient's sister will be expected to do the same. The patient's sister does not have to live in the same area as the patient, but must be willing to complete the study as well.

Please contact Dawn Billingsley at 760-598-1700.

6. An Open-Label, Multicenter, Single Arm Phase II Study of an Oral Study Drug as Single Agent Therapy in subjects with Advanced or Metastatic Breast Cancer who Have Progressed While Receiving Herceptin Containing Regimens

Target Populations:
· Patients must have refractory Stage IIIB or Stage IV breast cancer
· Patients must have had no more than TWO prior regimens for Stage IV breast cancer
· Patients must be Her2neu positive.

Patients will who qualify for this trial will take the study drug daily in pill form. All patients on study receive the same treatment.

Please contact Dawn Billingsley at 760-598-1700.

7. Neoadjuvant Treatment and Molecular Characterization of Locally Advance Breast Cancer

Target Populations:
· Patients must have infiltrating adenocarcinoma of the breast
· Patients who have prior radiation to the breast are excluded
· Patients who have evidence of metastasis will be excluded

Patients will receive 4 cycles of neoadjuvant chemotherapy based on their Her2neu testing results. Patients' tumor will then be surgically resected followed by four more cycles of chemotherapy and then radiation therapy.

Please contact Christine DeFrancisco at 760-598-1700.

8. A Phase III Randomized, Placebo-Controlled, Double-Blind Study of an Oral Study Drug Administered in Combination with a Standard Hormonal Therapy verses a Standard Hormonal Therapy Alone in Postmenopausal Women with Locally Advanced or Metastatic Breast Cancer

Target Populations:
· Patients must have Stage IIIB or Stage IV breast cancer
· Patients must be postmenopausal
· Patients must be estrogen receptor positive and/or progersterone receptor positive
· Patients with disease in their bones ONLY will be excluded from the study
· Patients may not have had more than 1 prior chemotherapy regimen for metastatic breast cancer

Patients will be randomized in a 1 to 1 fashion to receive either the oral study drug plus a standard hormonal therapy or the standard hormonal therapy alone. The study drug is a novel anticancer agent.

Please contact Dawn Billingsley at 760-598-1700.