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Blue Ridge Cancer Care
Clinical Trials Spring 2007
BREAST  l   LEUKEMIA  l  LUNG  l  LYMPOMAS  l  PANCREATIC  l  PROSTATE  l  RECTAL
At Blue Ridge Cancer Care, we believe that clinical trials are an integral part of our efforts to provide cancer patients access to the latest therapies and treatment options.

We are pleased to share with you a representative sampling of the current trials that are available at Blue Ridge Cancer Care. If you have any questions about our clinical research program or how we can help any of your patients, please Contact Blue Ridge Cancer Care.

Ph II ICb with/without Erbitux in MBC pts
Randomized Phase II Study of Weekly Irinotecan/Carboplatin (ICb) with or without Cetuximab (Erbitux) in Patients with Metastatic Breast Cancer (CA225200).

Ph II Doxil & Carboplatin plus HER2+ MBC
Phase II Study of Doxil and Carboplatin, plus Herceptin in HER2+ Patients, in Metastatic Breast Cancer (MBC).

Pilot Tamoxifen>Femara 40s ES/LA BrCa
Pilot Study of Femara Following 1-5 Years of Tamoxifen in Women in Their 40s with Early Stage or Locally Advanced Breast Cancer Who Have Ceased Menstruating with Adjuvant Chemotherapy.

Ph II Weekly ABI007/Avastin Met BrCa
A Phase II Trial Of Weekly Administration Of ABI-007 In Combination With Bevacizumab In Women With Metastatic Breast Cancer (CA043).

Taxotere/Cytoxan
TC (Taxotere/Cytoxan) plus Herceptin in HER2-Positive Early Stage Breast Cancer Patients

USOR# 06090
Phase III Trial of Adjuvant TC (Taxotere and Cytoxan) vs TAC (Taxotere, Adriamycin and Cytoxan) in Early Stage HER2- Negative Breast Cancer

PharmaMar# ET-B-027-06; USOR# 06166
Phase II, multicenter, open-label, clinical trial of Yondelis® (Trabectedin) in Metastatic Breast Cancer Patients with triple negative profile (ER-, PR-, HER2-), HER2 overexpressing tumors and BRCA1 or BRCA2 mutation carriers

USOR # 05098
A Randomized, Multi-Center Phase IIIb, Open Label, Study of Letrozole vs Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer (CFEM345D2411) We have been approved and currently waiting on the regulatory documents.

Ph III FCR vs PCR untx'd & tx'd CLL
A prospective, randomized, open label, phase III trial of fludarabine, cyclophosphamide, and rituximab vs. pentostatin, cyclophosphamide, and rituximab in previously untreated or treated b-cell chronic lymphocytic leukemia.

Ph III Doce or Alimta +/- Erbitux 2Ln NSCLC
Randomized Phase III Study of Docetaxel or Pemetrexed with or without Cetuximab in Patients with Recurrent or Progressive Non-Small Cell Lung Cancer after Platinum-Based Therapy (IMCL CP02-0452).

Ph III Talab+Doc v Plcbo+Doc 2nd3rdLn NSCLC
A Phase III, Randomized, Double-Blind, Multicenter Study of Talabostat and Docetaxel versus Docetaxel and Placebo in Patients with Advanced (Stage IIIB/IV) Non-Small Cell Lung Cancer (NSCLC) after Failure of Platinum-Based Chemotherapy (PTH-304).

Ph II Alimta+C +/- Enz v Doce+C AdvNSCLC
A Randomized, Open-Label Phase II Study of Pemetrexed (Alimta) plus Carboplatin with or without Enzastaurin Hydrochloride, or Docetaxel plus Carboplatin as First Line Treatment in Patients with Advanced Stage Non-Small Cell Lung Cancer (NSCLC).

Ph III Talab+Alim v Plcbo+Alim NSCLC PostPt
A Phase III, Randomized, Double-Blind, Multicenter Study of Talabostat and Pemetrexed versus Pemetrexed and Placebo in Patients with Advanced (Stage IIIB/IV) Non-Small Cell Lung Cancer (NSCLC) after Failure of Platinum-Based Chemotherapy (PTH-305).

Amrubicin 2nd Line Refractory ED-SCLC
A Phase II Trial of Single-Agent Amrubicin in Patients with Extensive Disease Small Cell Lung Cancer that is Refractory or Progressive within 90 Days of Completion of First-Line Platinum-based Chemotherapy.

Ph II Amrub v Topotec 2ln SCLC; Sen 1ln
A Randomized Phase II Trial Comparing Amrubicin versus Topotecan as Second-Line Treatment in Patients with Extensive Small Cell Lung Cancer Sensitive to First-Line Chemotherapy (CNF3140-SCLC-05004).

Tarceva Adjuv NSCLC Pts and EGFR+tumor
A Multi-center Randomized, Double-blind, Placebo-controlled, Phase III Study of Single-agent Tarceva (erlotinib) Following Complete Tumor Resection with or without Adjuvant Chemotherapy in Patients with Stage IB-IIIA Non-small Cell Lung Carcinoma who have EGFR-Positive Tumors.

Protocol AVF3671g
A Randomized, Double-blind,Placebo-controlled, Phase IIIb Trial Comparing Bevacizumab therapy with or without Erlotinib after completion of chemotherapy with Bevacizuman for the first-line treatment of locally advanced, recurrent, or metastatic NSCLC.

Ph II VELCADE Indol Lym Rel/Ref Rituxan
A Phase II Study of VELCADE in Patients with Relapsed or Refractory Indolent Lymphoma.

Ph II Gem±Enzastaurin 1stLn Met Pancreatic
A Randomized, Open-Label Phase II Study of 2 Regimens, Gemcitabine plus Enzastaurin and Single-Agent Gemcitabine, in Patients with Locally Advanced or Metastatic Pancreatic Cancer.

Ph III ASCENT-2 DN-101 w/ Docetaxel in AIPC
A Phase III, Randomized, Open-label Study Evaluating DN-101 in Combination with Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2).

Ph II XELOX/Avastin Q2vQ3 1st Ln MCRC
"XELOX-A-DVS" (Dense Vs Standard): A Randomized Study of Intermittent Capecitabine in Combination with Oxaliplatin (XELOX Q3W) and Bevacizumab versus Intermittent Capecitabine in Combination with Oxaliplatin (XELOX Q2W) and Bevacizumab as First-Line Treatment for Patients with Metastatic Colorectal Cancer (ML18491).

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