Contents:

      
Investigator-Initiated Studies
    
CTN Protocol Highlight
    
Cooperative Group Studies
     
Cooperative Group Trial Activations

INVESTIGATOR-INITIATED STUDIES
Contact Information and Regulatory Updates within the month of February 2008.

ACTIVE STUDIES

Velcade (Bortezomib) for Injection Therapy for Early Relapsed Prostate Cancer
CTO: 100822
PI: Andrew S. Kraft, MD
Participating Network Members:
Loma Linda University Cancer Institute
South Carolina Oncology Associates, PA
Spartanburg Regional Healthcare System
University of California at Irvine (pending)

• Patients Enrolled: 17 out of 42
   

Phase II Study of Neo-Adjuvant Cisplatin, Gemcitabine and Bevacizumab, Followed by Radical Cystectomy for Patients with Muscle-Invasive, Resectable, Non-Metastatic Transitional Cell Carcinoma (TCC) of the Bladder
CTO: 100892
PI: Andrew Kraft, MD
Participating Network Member:
Spartanburg Regional Healthcare System

• Patients enrolled: 12 out of 25

• Bevacizumab SAEs posted to Members' Workbench on 02.27.08

Multicenter Randomized Phase II Study of Erlotinib, Cisplatin, and Radiotherapy versus Cisplatin and Radiotherapy in Patients with Stage III and IV Squamous Cell Carcinoma of the Head and Neck
CTO: 100949
PI: Anand Sharma, MD
Participating Network Members:
McLeod Regional Medical Center
Spartanburg Regional Healthcare System

• Patients enrolled: 1 out of 18
  
  
• Cisplatin SAEs posted to Members' Workbench on 02.19.08

Phase II Study of Neoadjuvant Gemcitabine/Oxaliplatin and Cetuximab followed by Surgery or concurrent External Beam Radiation with Capecitabine for Patients with Locally Advanced Unresectable Nonmetastatic Pancreatic Cancer
CTO: 100918
PI: Andrew Kraft, MD
Participating Network Members:
McLeod Regional Medical Center
Spartanburg Regional Healthcare System

• Patients enrolled: 28 out of 39
  
  
• There is a temporary hold on subcenters at this time.  Centers will be reactivated upon further notice.
  

Azacitidine with Rituximab, Vincristine, and Cyclophosphamide in Refractory Follicular Lymphoma: A Phase I Trial
CTO: 101109
PI: Alberto Montero, MD
Participating Network Members:
University of Kentucky (pending)

• Patients enrolled: 0 out of 15

PENDING STUDIES

Phase I/II Trial of Bortezomib and Bevacizumab ("BB-mib-mab") in Patients with Advanced or Recurrent Renal Cell Cancer (RCC) with Assessment of Tissue Correlates of Response
CTO: 101098
MUSC PI: Andrew Kraft, MD
Network Member Reviewing Study:
South Carolina Oncology Associates, PA

STUDY CLOSURES

No recent study closures to report.

CTN PROTOCOL HIGHLIGHT

Multicenter Randomized Phase II Study of Erlotinib Cisplatin and Radiotherapy versus Cisplatin and Radiotherapy in Patients with Stage III and IV Squamous Cell Carcinoma of the Head and Neck

CTO: 100949
PI: Anand Sharma, MD
Primary Objective: Compare the complete response rate in patients with locally advanced head and neck cancer, treated with cisplastin, radiotherapy and erlotinib versus cisplatin and radiotherapy alone.

Inclusion Criteria:

• Cytological or pathological documented squamous cell carcinoma of oral cavity, oropharynx, larynx, and hypopharynx.  Patients with nasopharyngeal carcinoma can be included if the patients have grades I or II tumors according to the WHO classification.
• Stage III or IV according to the AJCC Cancer Staging Manual, Sixth Edition (2002).
• Unresectable or resection with significant morbidity.
• Measurable Disease, defined according to RECIST Criteria.
• Adequate Organ Function.
       a) Hepatic: Bilirubin < 1.5 X ULN, AST and ALT < 3.0 x ULN.
       b) Renal: Calculated creatinine clearance > 55 mL/min (using the 
       Cockcroft-Gault formula).
       c) Bone Marrow Reserve: Platelet count > 100 x 10^9 /L, ANC >
       1.25 x 10^9 /L. 
• Age > 18.
• Signed consent form.
• Male and female patients with reproductive potential must use an acceptable contraceptive method.
• Authorization from a dentist to begin radiation therapy.

If You Are Interested in Activating the Trial at Your Site, Please complete a Study Request Form and Fax the Completed Form to the Network Office at 843-876-1963.

If You Have a Potential Patient, Please Contact Our Participating Sites in South Carolina:
Medical University of South Carolina
PI: Anand Sharma, MD
SC: Christina Wilhoit, wilhoit@musc.edu

Spartanburg Regional Healthcare System
PI: James Bearden, III, MD
SC: Pam Bishop, pbishop@srhs.com
       Carol Drum, cdrum@srhs.com

McLeod Health
PI: Rajesh Bajaj, MD
SC: Jo Capototsi, jcapotosti@mcleodhealth.org
       Martha Adams, MaAdams@mcleodleath.org

                                                                               

COOPERATIVE GROUP STUDIES
Network Cooperative Group Studies

Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) vs. Partial Breast Irradiation (PBI) for Women with Stage 0, I, II Breast Cancer
Protocol ID: NSABP B-39
Participating Network Members:
Carolina Regional Cancer Center
Georgetown Hospital System

Phase III Randomized Study of Hypofractionated 3D-CRT/IMRT vs. Conventionally Fractionated 3D-CRT/IMRT in Patient Treated for Favorable-Risk Prostate Cancer
Protocol ID: RTOG 0415
Participating Network Member:
Carolina Regional Cancer Center

A Randomized Phase III Trial of Neoadjuvant Therapy in Patients with Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel when Administered Before AC with or without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR with Each of the Regimens
Protocol ID: NSABP B-40
Network Member Reviewing Study:
Georgetown Hospital System

Phase III Randomized Trial of Anastrozole vs. Anastrozole and Fulvestrant as First Line Therapy for Post-Menopausal Women with Metastatic Breast Cancer
Protocol ID: SWOG 0226
Participating Network Member:
The Regional Medical Center of Orangeburg and Calhoun Counties

PENDING STUDIES

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
Protocol ID: ECOG 5202
Network Member Reviewing Study:
Georgetown Hospital System

Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Pre-operative Chemoradiation
Protocol ID: ECOG 5204
Network Member Reviewing Study:
Georgetown Hospital System

A Phase III Trial of Irinotecan / 5-FU / Leucovorin or Oxaliplatin / 5-FU / Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum
Protocol ID: (SWOG) C80405
Network Member Reviewing Study:
Georgetown Hospital System

STUDY CLOSURES

No recent study closures to report.
                                                                                                                                    

COOPERATIVE GROUP TRIAL ACTIVATIONS
Below is a listing of newly activated cooperative group trials activated between February 15, 2008 to March 1, 2008. If you would like to review any of the protocols listed below, please view the information on the cooperative group websites or contact the Network Office.

ACOSOG
No newly activated studies.

CTSU
RTOG 0534
Activation: 02/22/08
A Phase III Trial Of Short Term Androgen Deprivation With Pelvic Lymph Node Or Prostate Bed Only Radiotherapy (SPORT) In Prostate Cancer Patients With A Rising PSA After Radical Prostatectomy

CALGB
No newly activated studies.

GOG
GOG 0238
Activiation: 02/25/08
A Randomized Trial Of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin In Patients With Pelvic-Only Recurrence of Carcinoma of The Uterine Corpus

NSABP
No newly activated studies.

RTOG
No newly activated studies.

SWOG
S0727
Activation: 03/01/08
A Phase I and Randomized Phase II Trial of Gemcitabine + Erlotinib (NSC-718781) + IMC-A12 (NSC-742460) vs. Gemcitabine + Erlotinib as First Line Treatment in Patients with Metastatic Pancreatic Cance