New England Hematology/Oncology: Clinical studies

Our physicians participate in Clinical Trials, which are research studies designed to offer access to new and potentially more effective treatments. Patients who elect to enter clinical trials are among the first to receive a new treatment. Clinical trials are important because many cancers are unfortunately difficult to treat and careful research may pave the way for enhanced treatment. The latest advances in cancer management are incorporated into many of these trials.

Patients who are interested in trials must meet certain conditions related to type of cancer, previous treatment and physical status. Eligibility is determined by our Research Coordinator, who outlines details of the trial in an informed consent statement which must be signed to enter the trial. Patients may withdraw from a research study at any time.

The following lists our most recent clinical trials. Very soon, NEHOA will be teaming up with the Dana Farber Cancer Institute as a research affiliate and our list of research studies will change. In the meantime, please contact Judy Chow, our Research Coordinator, for more information.

New England Hematology/Oncology Associates
Protocols Open for Patient Accrual

Note: Breast cancer studies updated 4/06; others in process of being updated

ECOG stands for the Eastern Cooperative Oncology Group, a large multi-institutional group of cancer centers which conducts clinical trials. New England Hematology/Oncology is closely associated with this acclaimed research group.

CALGB stands for the Cancer And Leukemia Group B, another large cooperative research group.

NSABP stands for the National Surgical Adjuvant Breast and Bowel Project, a third large national cooperative research group.

GOG stands for Gynecologic Oncology Group, a national cooperative group specializing in studies for ovarian, uterine and cervical cancer.

NCIC are studies through the National Cancer Institute of Canada.

IBCSG stands for the International Breast Cancer Study Group

Industry protocols investigate the use of new anti-cancer therapies and are sponsored by companies who have developed these treatments.

Genetic Testing: We currently offer genetic testing for breast/ovarian cancer susceptibility genes and for hereditary nonpolyposis colon cancer syndrome.

BREAST CANCER

Standard Treatment for breast cancer patients requiring chemotherapy after surgery has been Cytoxan and Adriamycin, often with Taxol or Taxotere and often in a "dose dense" accelerated fashion. In Her2/Neu-positive tumors, Herceptin is often added. Studies are now being conducted to determine which combination and dosing offer longest disease free survival. Tamoxifen and/or Aromatase Inhibitors are standardly given to patients with positive estrogen receptor or progesterone receptor status.

ADJUVANT (PREVENTATIVE) STUDIES

NSABP-B35 A Clinical Trial comparing Anastarzole (Arimidex) with Tamoxifen in postmenopausal patients with Ductal Carcinoma in Situ (DCIS) undergoing lumpectomy with radiation therapy

CALGB 49907 Adjuvant Chemotherapy with Standard Regimens: (CMF) or (AC), vs. Capecitabine in Women 65 Years and Older with Node-Positive or High-Risk Node-Negative Breast Cancer

SOFT Trial: IBCSG 24-02 Phase III Trial evaluating the role of ovarian function suppression and the role of Exemestane (Aromasin) as adjuvant therapies in premenopausal women with endocrine responsive breast cancer

NCIC-MA.27 A Randomized Phase III Trial of Exemestane (Aromasin) versus Anastrozole (Arimidex) with or without Celecoxib in Postmenopausal Women with Receptor Positive Primary Breast Cancer

SWOG S0221 Phase III Trial of continuous schedule AC + G vs. every 2 week schedule AC followed by Paclitaxel (Taxol) given either every 2 weeks or weekly for 12 weeks in post-operative adjuvant therapy in node-positive or high-risk node negative breast cancer

METASTATIC BREAST CANCER STUDIES

E2103 Phase II Trial of Trastuzumab (Herceptin) plus weekly Ixabepilone (BMS-247550) and Carboplatin in patients with HER2/Neu-positive metastatic breast cancer

GASTROINTESTINAL CANCERS

E4201 A Randomized Phase III Study of Gemcitabine in Combination with Radiation Therapy versus Gemcitabine Alone in Patients with Localized, Unresectable Pancreatic Cancer Pending

E6201 Phase III Study of Gemzar and Oxaliplatin vs. Gemzar (Fixed Dose Rate Infusion) vs. Gemzar (30-Minute Infusion) in Pancreatic Carcinoma

R9811 Phase III Trial of 5F-U Mitomycin-C and Concurrent Radiotherapy vs. Induction 5F-U, Cisplatin followed by Concurrent 5F-U, Cisplatin and Radiotherapy in Carcinoma of the Anal Canal

GENITOURINARY CANCERS

ECOG Studies
E1899 A Phase III Randomized Trial for Evaluating Second Line Hormonal Therapy (Ketoconazole/ Hydrocortisone) versus Docetaxel/Estramustine Combination Chemotherapy on Progression Free Survival in Asymptomatic Patients with a Rising PSA after Hormonal Therapy for Prostate Cancer

S9346 Intermittent Androgen Deprivation – Stage D2 Prostate Cancer. A 7-month induction regimen of combined androgen deprivation (Casodex) and (Zoledex) until progression

GYNECOLOGIC CANCERS

GOG-0198 A Randomized Study of Tamoxifen Versus Thalidomide (NSC# 66847) In Patients with Biochemical-Recurrence-Only Epithelial Ovarian Cancer, Cancer of the Fallopian Tube, and Primary Peritoneal Carcinoma After First Line Chemotherapy Pending

LEUKEMIA

C9710 Trial of Concurrent Tretinoin and Chemotherapy w/wo Arsenic Trioxide as Initial Consolidation Therapy Followed by Maintenance with Intermittent Tretinoin plus Mercaptopurine and Methotrexate for Patients w/Untreated Active Promyelocytic Leukemia

E1900: A Phase III Trial in Adult Acute Myeloid Leukemia:Daunorubicin Dose-Intensification and Gemtuzumab-Ozogamicin Consolidation Therapy Prior to Autologous Stem Cell Transplantation Pending

E2993 Autologous & Allogenic BMT vs. Conventional Chemotherapy: First Remission ALL.
ATC or induction therapy plus transplant

E2997 Phase III Trial of Fludarabine and Cyclophosphamide versus Fludarabine in Previously Untreated CLL

E8998 Phase II Trial of Campath-1H and Peripheral Blood Stem Cell Transplant for Patients with CLL

LYMPHOMA

S9704 Phase III Trial Comparing Early High Dose RT and ASCT vs. CHOP + Rituxan (Possible Late ASCT) for DA NHL in High-Intermediate and High Risk Prognostic Groups

MELANOMA

ECOG Studies
E4697 Phase III Trial of GM-CSF versus Peptide Vaccine versus GM-CSF+ Peptide vs. Placebo After Complete Resection of “Locally Advanced” and/or Stage IV Melanoma

THORACIC CANCERS

ECOG Studies
E1500 Phase II Trial of Two Dose Levels of CCI-779 in Patients w/Stage III/IV S mall Cell Lung Cancer Who Are Stable After Induction Chemotherapy

S9900 Phase III Trial of Surgery Alone or Surgery + Pre-op Paclitaxel/Carboplatin in Stage IA, IB + Selected Stage IIIA NSCLC

E5597 Phase III Chemo-prevention Trial of Selenium Supplementation in Persons with Resected Stage I NSCLC

E3598 Phase III Trial of Carboplatin, Paclitaxel and Thoracic Radiotherapy, with or Without Thalidomide, in Patients with Stage III NSCLC

E4599 Phase II/III Trial of Paclitaxel Plus Carboplatin with or without Bevacizumab in Patients with Advanced Non-Squamous NSCLC

C9633 Phase III Study of Adjuvant Taxol/Carboplatin After Resection for Patients with T2N0 Stage I NSCLC vs. Resection Alone

NCIC-BR.19A Phase III Prospective Randomized, Double-Blind, Placebo-Controlled Trial of the Epidermal Growth Factor Receptor Antagonist, ZD1839 (IRESSA) in Completely Resected Primary Stage IB, II and IIIA Non-Small Cell Lung Cancer

Industry Protocols
POI-01-004-020 - “A Phase II Study of Irinotecan HCI and Gemcitabine with or without Celecoxib in Stage IIIB/IV Advanced Non-Small Cell Lung Cancer”

BRAIN TUMORS

R9813 Phase I/III Randomized Study of Radiation Therapy And Temozolomide Versus Radiation Therapy And BCNU for Anaplastic Astrocytoma (IND #60,265)