Clinical Trials: Current Open Trials

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PRINTABLE VERSION Breast Cancer Central Nervous System Esophageal Cancer Gastrointestinal Disease Genitourinary Gynecologic Cancers     Head and Neck Leukemia Non-Small Cell Lung Cancer Small-Cell Lung Cancer Lymphoma Melanoma     Multiple Myeloma Prostate Prevention Pancreatic Cancer Sarcomas Other Cancer Sites Disease Category Protocol Description Contacts Breast Cancer Prevention NSABP P-2 "STAR" Trial NSABP P-2: Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer. Eligibility: Postmenopausal women age 35 and older at increased risk for breast cancer RN: Jamie Breeden, RN,CCRC (865) 541-2421 Breast Cancer S 9927 "Randomized Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in Women with One to Three Positive Axillary Nodes, Phase III" Eligibility: Primary tumor < 5 cm and 1-3 positive axillary nodes No prior herceptin therapy No metastatic disease TCSC Clinical Trials Department (865) 541-1812 S N9831 "Phase III Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Paclitaxel with or without Trastuzumab as Adjuvant Treatment for Qomen with HER-2 Overexpressing Node Positive Breast Cancer" Eligibility: Breast Cancer with positive lymph nodes Strong overexpression of HER-2/neu No prior treatment for breast cancer TCSC Clinical Trials Department (865) 541-1812 SWOG E1199 A Phase III Study of Doxorubicin-Cyclophosphamide Therapy followed by Paclitaxel or Docetaxel Given Weekly or Every 3 Weeks in Patients with Axillary node-Positive Breast Cancer. Eligibility: Stage IA, IIA, and IIIA. Patients must have had all tumor removed and have had no prior treatment for breast cancer. TCSC Clinical Trials Department (865) 541-1812 Sarah Cannon BRE 37 A Randomized, Multicenter Trial Comparing Regimens of Doxorubicin+ Cyclophosphamide Followed by Paclitaxel (every 3 weeks for four cycles) and Doxorubicin+ Paclitaxel Followed by Weekly Paclitaxel as Adjuvant Therapy for Female Patients with High Risk Breast Cancer. Eligibility: Patients with operable, histologically confirmed adenocarcioma of the breast. Must have had no prior treatment for breast cancer. TCSC Clinical Trials Department (865) 541-1812 TAX/Men.10 A Multicenter, Open-Label, Randomized Study of Three Schedules of Weekly Taxol Induction Therapy followed by Weekly Taxol maintenance therapy in metastatic Breast Cancer Patients. Eligibility: May have had 0-1 prior chemotherapy regimens for metastatic disease that did not involve a taxane. If adjuvant therapy contained a taxane, must have been disease free for 12 months from completion of treatment. TCSC Clinical Trials Department (865) 541-1812       Disease Category Protocol Description Contacts Central Nervous System SWOG-RTOG 98-02 A Phase II Study of Observation in Favorable Low Grade Glioma and a Phase III Study of Radiation with or without PCV Chemotherapy in Unfavorable Low-Grade Glioma. Eligibility: Grade II astrocytoma, oligodendroglioma, or oligoastrocytoma TCSC Clinical Trials Department (865) 541-1812 PCI p120-9801 Phase III Randomized Trial of Gadolinium Texaphyrin (PCI-0120) as a Radiation Sensitizer in Patients Receiving Whole Brain Radiation Therapy for the Treatment of Brain Metastases Eligibility: Brain metastasis for most cancers except: small cell lung, lymphoma, and leukemia. No liver metastasis, prior brain radiation or resection, or two or more extracranial sites of metastasis. Sue Bales, R.N. (865) 541-1893 Disease Category Protocol Description Contacts Esophageal Cancer Sarah Cannon GI 23 Paclitaxel, Carboplatin, Infusional 5-Fluorouracil, and Radiation Therapy with or without Surgical Resection in Locally Advanced Esophageal Cancer. Eligibility: Must have squamous cell, adenocarcinoma, or adenosquamous carcinoma of the esophagus (Stage I, II, or III). Must not have had prior treatment for esophageal cancer. TCSC Clinical Trials Department (865) 541-1812 Disease Category Protocol Description Contacts Gastrointestinal Disease SWOG C9581 Phase III Randomized Study of Adjuvant Immunotherapy with Monoclonal Antibody 17-1A vs. No Adjuvant Therapy Following Resection for Stage II (Modified Astler-Coller B2) Adenocarcinoma of the Colon. Eligibility: Complete resection of disease and no distant metastasis TCSC Clinical Trials Department (865) 541-1812 SWOG 9444 Gastrointestinal Tumor Repository Protocol, Ancillary. Eligibility: Enrollment on SWOG Gastrointestinal treatment protocol TCSC Clinical Trials Department (865) 541-1812 SWOG N9841 A Randomized Phase III Equivalence Trial of Irinotecan (CPT-11) Versus Oxaliplatin (OXAL)/5-Fluorouracil (5-FU)/Leucovorin (CF) in Patients with Advanced Colorectal Carcinoma Previously Treated with 5-FU. Eligibility: Locally advanced, locally recurrent, or metastatic colorectal carcinoma not curable by surgery or radiation. TCSC Clinical Trials Department (865) 541-1812 SWOG 9700 A Phase II Trial of Infusional 5-Fluorouracil (5-FU), Calcium, Leucovorin (LV), Mitomycin-C (Mito-C), and Dipyridamole (D) in Patients with Locally Advanced Unresected Pancreatic Adenocarcinoma. Eligibility: Stage II or III disease not amenable to curative surgery. Must not have had prior chemotherapy or radiation. TCSC Clinical Trials Department (865) 541-1812 Disease Category Protocol Description Contacts Genitourinary Sarah Cannon GU 7 A Phase II Trial of Paclitaxel, Carboplatin, and Gemcitabine in the Treatment of Advanced Transitional Cell Carcinoma of the Urothelial Tract. Eligibility: No more than 1 prior systemic chemotherapy regimen for bladder cancer. Prior treatment cannot have been: Paclitaxel, Docetaxel, or Gemcitabine. TCSC Clinical Trials Department (865) 541-1812 SWOG 9346 Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer, Phase III. Eligibility: Stage D2, as evidenced by soft tissue and/or bony metastasis Sue Bales, R.N. (865) 541-1893 SWOG 9916 Docetaxel and Estramustine VS. Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer, Phase III. Eligibility: Stage D1 or D2 disease unresponsive or refractory to hormone therapy Sue Bales, R.N. (865) 541-1893 Disease Category Protocol Description Contacts Gynecologic Cancers   **NO STUDIES AT THE PRESENT TIME** TCSC Clinical Trials Department (865) 541-1812 Disease Category Protocol Description Contacts Head and Neck   **NO STUDIES AT THE PRESENT TIME** TCSC Clinical Trials Department (865) 541-1812 Disease Category Protocol Description Contacts Leukemia S 0010 "A Phase II Trial of 506U78 in Patients with Relapsed or Refractory Non T-cell Acute Lymphoblastic Leukemia (ALL)" Eligibility: No CNS involvement TCSC Clinical Trials Department (865) 541-1812 SWOG C9710 Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy with or without a Single Course of Arsenic Trioxide (AS203) as Initial Consolidation Therapy Followed by Intermittent Vs. Continuous Tretinoin Maintenance Therapy for Patients with Untreated Acute Promyelocytic Leukemia (APL). Eligibility: Must not have had prior treatment for APL. TCSC Clinical Trials Department (865) 541-1812 SWOG 9910 Leukemia Centralized Reference Laboratories and Tissue Repositories – Consent to Perform Cellular and Molecular Studies in Leukemia Patients. Eligibility: Enrolled on SWOG treatment study for lymphoid leukemia (ALL or CLL) TCSC Clinical Trials Department (865) 541-1812 Disease Category Protocol Description Contacts Non-Small Cell Lung Cancer P30-302 Mesothelioma A Multicenter Randomized Comparative Phase III Trial of Onconase Plus Doxorubicin verses Doxorubicin in Patients with Malignant Mesothelioma (Part II). Eligibility: No prior treatment or only 1 chemotherapy regimen that did not include Doxorubicin or Onconase Sue Bales, R.N. (865) 541-1893 SWOG JBR10 A Phase III Prospective Randomized Study of Adjuvant Chemotherapy with Vinorelbine and Cisplatin in Completely Resected Non-Small Cell Lung Cancer with Companion Tumor Marker Evaluation. Eligibility: Must not have had prior breast cancer, melanoma, or hypernephroma TCSC Clinical Trials Department (865) 541-1812 SWOG 9900 A Randomized Phase III Trial Surgery Alone or Surgery Plus Peroperative Paclitaxel/Carboplatin in Clinical Stage IB (T2NO), II (T1-2N1), T3NO) and Selected IIIA (T2N1) Non-Small Cell Lung Cancer (NSCLC). Eligibility: Must not have had prior systemic chemotherapy or radiation treatment TCSC Clinical Trials Department (865) 541-1812 Sarah Cannon LUN 35 Preoperative (Neoadjuvant) or Postoperative (Adjuvant) Therapy of Stage IB, II, IIIA, and Selected IIIB Patients with Non-Small Cell Lung Cancer. Eligibility: Must not have had prior chemotherapy or radiation treatment. TCSC Clinical Trials Department (865) 541-1812 ZD0473IL/0003 A Phase II Open, Multicenter Trial to Assess the Activity and Tolerability of ZD0473 Given Intravenously as Second-line Therapy to Patients with Non-Small Cell Lung Cancer Who Have Failed One Prior Platinum Based Chemotherapy Regimen.. Eligibility: Progressive or relapsing disease. Must have received prior treatment with a platinum-based chemotherapy TCSC Clinical Trials Department (865) 541-1812 ZD 1839IL/0017 A Randomized, Double-Blind, Phase III Comparative Trial of 2 Doses of ZD1839 (IRESSAä ) in Combination with Paclitaxel and Carboplatin Versus Placebo in Combination with Paclitaxel and Carboplatin in Chemotherapy-Naïve Patients with Advanced (Stage III or IV) Non-small Cell Lung Cancer. Eligibility: Stage III disease not curable with surgery or radiation. Stage IV disease eligible, as well. No brain metastsis or previous diagnosis of brain mets. that has been stable for at least 2 months. Must not have had prior treatment for non-small cell lung cancer. TCSC Clinical Trials Department (865) 541-1812 Disease Category Protocol Description Contacts Small-Cell Lung Cancer LUN 40 Phase II Trial of Paclitaxel, Carboplatin, and Topotecan and Radiation Therapy in the Treatment of Limited Stage Small Cell Lung Cancer. Eligibility: Must not have had prior therapy for small cell lung cancer. TCSC Clinical Trials Department (865) 541-1812 SWOG C9732 A Randomized Phase III Study Comparing Etoposide and Cisplatin with Etoposide, Cisplatin, and Paclitaxel in Patients with Extensive Small Cell Lung Cancer. Eligibility: No prior chemotherapy for small cell lung cancer. No prior pelvic or mediastinal radiation. TCSC Clinical Trials Department (865) 541-1812 ZD04731L/0004 A Phase II Open, Multicenter Trial to Assess the Activity and Tolerability of ZD0473 Given Intravenously as Second-Line Therapy to Patients with Small Cell Lung Cancer who Have Failed One Prior Platinum Based Chemotherapy Regimen. Eligibility: Progressive or relapsing disease. Must have received prior treatment with a platinum-based chemotherapy. TCSC Clinical Trials Department (865) 541-1812 Disease Category Protocol Description Contacts Lymphoma S E2496 "Randomized Phase III Trial of ABVD vs. Stanford V + Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease with 0-2 Risk Factors" Eligibility: Locally Extensive = Stage I-IIA/B and massive mediastinal adenopathy Advanced Stage = Stage III-IV Adverse Risk Factors = low Hemogobin, albumin, lymphocytes; Stage IV disease; increased white blood cells; age > 45 years old; male No prior radiation therapy or chemotherapy TCSC Clinical Trials Department (865) 541-1812 SWOG 0014 A Phase II Evaluation of Chop plus Rituximab plus Involved Field Radiotherapy for Stages I, IE and Non-Bulky Stages II and IIE, CD20 Positive, High Risk Localized Aggressive Histologies of Non-Hodgkin’s Lymphoma. Eligibility: Must have one of the following subtypes of NHL: diffuse large B-cell, Mantle cell, high-grade B-cell, Burkitt’s or Burkitt-like, or anaplasitc large cell (B-cell only). Must not have had prior chemotherapy, radiation, or monoclonal antibody treatment. TCSC Clinical Trials Department (865) 541-1812 Sarah Cannon LYM 5 Rituximab Induction Therapy Followed by Randomization of Responders to Maintenance Therapy with Rituximab vs. Treatment with Rituximab At The Time of Progression in Patients with Previously Treated Low-Grade Non-Hodgkin's Lymphoma Eligibility: Must have histologically proven low grade B-cell NHL. Must have had at least one previous chemotherapy regimen. No brain metastasis. No prior treatment with Rituximab. TCSC Clinical Trials Department (865) 541-1812 Sarah Cannon LYM 6 Phase II Trial of Chemotherapy with VNCOP-B Plus Rituxan in Previously Untreated Elderly Patients with Large-Cell Non-Hodgkin's Lymphoma. Eligibility: Must have biopsy-proven large-cell, B-cell NHL (Stage II, III, or IV). No brain metastasis. Must not have had prior treatment. TCSC Clinical Trials Department (865) 541-1812 Sarah Cannon LYM 8 Phase II Trial of Rituximab with Short Duration Chemotherapy as Initial Treatment for Low-Grade Follicular Non-Hodgkin’s Lymphoma. Eligibility: Low-grade, B-cell, follicular NHL (Stage II, III, or IV). No brain metastasis. No small lymphoid cell (CLL-type) lymphomas. Must not have had prior treatment. TCSC Clinical Trials Department (865) 541-1812 Sarah Cannon LYM 10 Phase II Trial of Rituximab as Initial Treatment for patients with Chronic Lymphoid Leukemia. Eligibility: Proven B-cell CLL or small lymphoid cell lymphoma (Stage II, III, or IV). No brain metastasis. Must not have had prior treatment. TCSC Clinical Trials Department (865) 541-1812 Disease Category Protocol Description Contacts Melanoma S 0008 "Phase III Trial of High Dose Interferon Alpha-2b vs. Cisplatin, Vinblastine, DTIC plus IL-2 and Interferon in Patients with High Risk Melanoma" Eligibility: No metastatic disease No prior radiation treatment, chemotherapy, or immunotherapy with interferon and/or interleukins TCSC Clinical Trials Department (865) 541-1812 Disease Category Protocol Description Contacts Multiple Myeloma SWOG 9922 A phase III trial of Dexamethasone, Cyclophosphamide, Etopiside, Cisplatin (DCEP) and G-CSF with or without Thalidomide (NSC #66847) as Salvage Therapy for Patients with Refractory Multiple Myeloma Eligibility: Must have received at least 1 and at most 2 prior treatment regimens. TCSC Clinical Trials Department (865) 541-1812 Disease Category Protocol Description Contacts Pancreatic Cancer Pharmicia 98-6475-183 A Randomized, Open-label, Multicenter, Phase III Study Comparing the Efficacy and Safety of Gemcitabine and Irinotecan HCl (CPT-11) to Gemcitabine Alone in Patients with Locally Advanced or Metastatic Pancreatic Cancer Who Have Not Received Prior Systemic Therapy. Eligibility: Must be surgically unresectable TCSC Clinical Trials Department (865) 541-1812 Disease Category Protocol Description Contacts Prostate Prevention S 0000 "Selenium and Vitamin E Cancer Prevention Trial (SELECT)" Eligibility: Males age 55 or older; African-American men may be age 50 or older due to increased incidence of the disease No uncontrolled high blood pressure, abnormal digital rectal exam, or elevated Prostate Specific Antigen (PSA) levels allowed TCSC Clinical Trials Department (865) 541-1812 Disease Category Protocol Description Contacts Sarcomas   **NO STUDIES AT THE PRESENT TIME** TCSC Clinical Trials Department (865) 541-1812 Disease Category Protocol Description Contacts Other Cancer Sites   **NO STUDIES AT THE PRESENT TIME** TCSC Clinical Trials Department (865) 541-1812 For More Information: Cancer Trials (National Cancer Institute)

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