Clinical Trials at Saint Peter's University Hospital

Open for Accrual

BREAST PROTOCOLS

RTOG 0413/NSABP B-39
A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Vs Partial Breast Irradiation (PBI) for Women with Stage 0, I, II Breast Cancer
PI: Alexander Haas, MD

Eligibility Criteria: Stage 0, I, II breast cancer under the age of 50. Tumor must be DCIS or invasive adenocarcinoma.

NSABP B-42
A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast Cancer
PI: Kathleen Toomey, MD

Eligibility Criteria: Histologically confirmed invasive carcinoma of the breast. ER- and/or PgR-positive. Postmenopausal. Must have had RT or total mastectomy. Received hormonal therapy following dx for 57-63 months or up to 3 years of Tamoxifen followed by an AI

CTSU – PACCT-1
Program for the Assessment of Clinical Cancer Tests – Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial
PI: Craig Lampert, MD

Eligibility Criteria: Confirmed adenocarcinoma with tumor ER and/or PR positive, HER2/nue negative. Negative nodes. Tumor size must be 1.1 to 5.0cm (or 5mm-1.0cm plus unfavorable histological features).

SWOG S0500
A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients Who Have Elevated Circulating Tumor Cell Levels at First Follow-up Assessment
PI: Kathleen Toomey, MD

Eligibility Criteria: Confirmed breast CA and clinical evidence of Stage IV disease. Patient must have not received any prior chemotherapy for metastatic disease. Patient’s whose only disease is non-measurable disease that does not include bone are ineligible.

ECOG E1105
A Randomized Phase III Double-Blind Placebo-Controlled Trial of First-Line Chemotherapy and Trastuzumab with or without Bevacizumab for Patients with HER-2/Neu Over-Expressing Metastatic Breast Cancer
PI: Kathleen Toomey, MD

Eligibility Criteria: Histologically confirmed breast CA that overexpresses HER-2 with evidence of metastatic disease and/or chest wall recurrence. Prior chemotherapy for metastatic breast cancer is not allowed.

ECOG E5103
A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive High Risk Lymph Node Negative Breast Cancer
PI: Edward Licitra, MD, PhD

Eligibility Criteria: Histologically confirmed adenocarcinoma of the breast at significant risk of distant recurrence. Involvement of at least 1 axillary LN on routine histological exam. ER negative tumor ≥ 1cm. ER+ tumor ≥5cm regardless of recurrence score. ER+ tumor ≥ 1cm but >5cm with recurrence score of ≥ 11 (may be enrolled in TAILORx trial)

MAMMOSITE

A Single Site Prospective, Non-Randomized Study of the MammoSite Radiation Therapy Delivery System (Breast Brachytherapy Applicator) to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities
PI: Gopal Desai, MD

Eligibility Criteria: Patients with Stage 0, I, or II breast CA with tumor size ≤3 cm. Low Risk, unicentric DCIS negative margins. Skin spacing between balloon surface and surface of skin ≥5mm.

CINJOG: 040504
Randomized Phase II Trial of Gemcitabine and Imatinib Mesylate Versus Gemcitabine Alone in Patients with Previously Treated Locally Advanced or Metastatic Breast Cancer
PI: Kathleen Toomey, MD

Eligibility Criteria: Histologically confirmed breast CA, locally advanced or metastatic. Progression after at least 1 prior chemotherapy regimen, but no more than 2.

CINJOG: 040702
Phase II Trial of Doxil, Carboplatin and Bevacizumab in Triple Negative Previously Untreated Metastatic Breast Cancer
PI: Kathleen Toomey, MD

Eligibility Criteria: Untreated metastatic breast cancer, ER/PR/ HER2/neu negative. Prior treatment in adjuvant setting is allowed.

CINJOG: 040703
Significance of Single Nucleotide Polymorphisms in Breast Cancer Patients Undergoing Radiation Therapy
PI: Gopal Desai, MD

Eligibility Criteria: Previous biopsy-confirmed diagnosis of breast cancer includes DCIS and invasive ductal carcinoma. Willing to have 20ml of blood drawn. Previously treated patients or patients planning to receive radiation therapy for breast cancer. Patients have undergoing breast conserving surgery or mastectomy with radiation.

BIG/NCCTG-ALTTO
Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Study A randomized, multi-centre, open-label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/Erb B2 positive primary breast cancer
PI: Edward Licitra, MD, PhD

Eligibility Criteria: Non-metastatic operable primary invasive adenocarcinoma of the breast. Axillary node positive OR node negative with a tumor ≥1.0 cm.

GASTROINTESTIONAL

ECOG E5202
A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin vs. 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
PI: Craig Lampert, MD

Eligibility Criteria: Histologically confirmed Stage II (T3,4N0M0) adenocarcinoma of the colon with tumor ≥12 cm from anal verge on endoscopy.

HEAD AND NECK

LORHAN
Head and neck Carcinoma Registry of Patients Receiving Therapy Other Than Surgical Resection Alone for Newly Diagnosed Head and Neck Carcinoma
PI: Gopal Desai, MD

Eligibility Criteria: Pathologically (histologically or cytologically) confirmed new diagnosis of carcinoma involving the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or neck node metastasis from unknown origin, and scheduled to receive radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy.

RTOG 0514
Establishment of a Head and Neck Cancer Tissue/Specimen Bank
PI: Gopal Desai, MD

Eligibility Criteria: Patients must have a suspected or confirmed diagnosis of head and neck cancer and must be potentially eligible for an active RTOG treatment study.

BRAIN

RTOG 0614
A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction I Patients Receiving Whole-Brain Radiotherapy
PI: Gopal Desai, MD

Eligibility Criteria: Pathologically proven diagnosis of solid tumor malignancy within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological (i.e., more recent) confirmation is required (e.g., from a systemic metastasis or brain metastasis).

GENITOURINARY

ECOG E2805
A Randomized Double-blind Phase III Trial Adjuvant Sunitinib Versus Sorafenib
Versus Placebo in Patients with Resected Renal Cell Carcinoma
PI: Sameer Desai, MD

Eligibility Criteria: If pre-surgery, patients must a) have primary-intact renal cell carcinoma (RCC), eligible for nephrectomy with curative intent, b) tumors must be ≥ 4 cm and/or macroscopic, fully resectable nodes and/or surgically resectable renal vein thrombus and/or surgically respectable IVC thrombus by radiologic criteria to be clinically ≥ pT1bNany (respectable) M0 disease, and c)multifocal ipsilateral RCC is allowed provided fully respectable and does not exceed inclusion criteria

LUNG

SWOG S0424
Molecular Epidemiology Case-Series Study of Non-small Cell Lung Cancer in Smoking and Non-Smoking Women and Men (Smoking Arm Closed)
PI: Gopal Desai, MD

Eligibility Criteria: Patients must have newly diagnosed, primary, histological confirmed Stage I, II, IIIA, IIIB (T4 or N3, excluding patients with malignant pleural effusion) NSCLC.

ECOG 1505
A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients with Completely Resected Stage IB (≥4cm) –IIIA Non-Small Cell Lung Cancer
PI: Edward Licitra, MD, PhD

Eligibility Criteria: Patients must have undergone complete resection of their NSCLC [stage IB (> 4 cm)] – [IIIA (T2-3N0, T1-3N1, T1-3N2] prior to enrollment. Accepted types of resection will consist of lobectomy, sleeve lobectomy, bi-lobectomy or pneumonectomy. Resections by segmentectomy or wedge resection will not be accepted. Mediastinal lymph node sampling at specified levels is required pre-operatively (mediastinoscopy) or intraoperatively (level 7 and 4 for right sided tumors or level 7 and 5 and/or 6 for left sided tumors).

GYNECOLOGICAL

CINJOG #100101
A Phase II Trial of Chemosensitization with Paclitaxel, 13-cis Retoinoic Acid and Interferon Alpha-2b in Advanced Uterine Cervical Carcinoma
PI: Kathleen Toomey, MD

Eligibility Criteria: Patients with histologically and/or cytologically proven metastatic, recurrent or persistent cervical cancer, who are not surgical candidates, will be eligible. Patients, in whom chemoradiation was given as initial therapy, must demonstrate progression of disease and be at least 4 weeks beyond the discontinuation of therapy. Patients with advance stages of disease that received chemoradiation, or radiation only, but radiation did not treat all tumor sites, would be able to start protocol therapy 2 weeks after completion of radiation treatment.

CONTACT LIST

Gopal Desai, M.D.
Chairman, Radiation Oncology
Telephone: (732) 745-8590

Alexander Haas, M.D.
Director, Radiation Oncology
Telephone: (732) 745-8590

Kathleen Toomey, M.D.
Medical Oncology
Telephone: (908) 927-8700

Craig Lampert, M.D.
Medical Oncology
Telephone: (732) 246-4882

Edward Licitra, M.D., Ph.D.
Medical Oncology
(732) 828-9570

Kathy Covert, APN, MSN, AOCN
Oncology Research Nurse
Telephone: (732) 745-8600 ext. 6163
Beeper: (732) 651-3970

Susan Maney
Oncology Research Coordinator
Telephone: (732) 745-8600 ext. 8295