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CHS CLINICAL TRIALS
Clinical Trials are available through Carolinas HealthCare System for the following types of cancer:
BRAIN CANCER (NEURO ONCOLOGY)
Brain tumor clinical research has developed rapidly at the Blumenthal Cancer Center. The center is currently involved in multiple Phase I, II, III protocols by both industry and large cooperative groups such as RTOG and SWOG.
- RTOG 0424
Temozolomide-Based Chemoradiotherapy Regimen for High Risk Low-Grade Gliomas. Phase II. (0, 8/05)
- Gliasite Registry
Solitary Brain Met, Surgery followed by Gliasite Implant followed by Brachytherapy.
- Guilford High
Surgery, Gliadel Wafer followed by TMZ ? TMZ plus Radiation Therapy followed by TMZ (for total of 12 cycles)
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BREAST CANCER
Breast cancer patients at Blumenthal Cancer Center have access to the most current and innovative research studies available in the United States. High-risk individuals who do not have breast cancer also may participate in national breast cancer prevention studies.
- Aventis 3001
RPR109881 IV Every 3 Weeks vs. Capecitabine Tablets 2x/Day for 2 Weeks in 3 Week Cycles for Metastatic Breast Progressing After Taxanes and Anthracycline Therapy. Phase III. (7, 3/04)
- CMC DDTNAC
Neoadjuvant, Stage II & III. Dose Dense Taxotere plus Navelbine vs. Taxotere followed by Adriamycin plus Cytoxan followed by Surgery. Phase II.
(127, 5/03)
- Wyeth 303
Randomized, Placebo-Controlled, Double-Blind Study of Oral CCI-779 + Letrozole vs. Letrozole Alone as First Line Hormonal Therapy in Postmenopausal Women with Locally Advanced or Metastatic Breast Cancer. Phase III. (3, 2/05)
- CTSU MA.27
Exemestane vs. Anastrozole in Postmenopausal Women w/ Receptor Positive Primary Breast Cancer. Phase III. (4, 12/03)
- IBCSG 24-02
Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women w/ Endocrine Responsive Breast Cancer. Phase III. (0, 12/03)
- NSABP B-35
DCIS, S/P Lumpectomy, Post Menopausal, RT + Tamoxifen vs. RT + Anastrazole. Phase III. (5, 8/03)
- NSABP B-36
Adjuvant Therapy Comparing 6 Cycles of 5-FU, Epirubicin and Cyclophosphamide (FEC) to 4 Cycles of AC in Pts. with Node-Negative Breast Cancer. Phase III. (I, 8/04)
- NSABP B-37
Adjuvant Chemo for Radically Resected Loco-Regional Relapse of Breast Cancer. Phase III. (0, 8/05)
- NSABP B-38
Adjuvant Trial Comparing Three Chemotherapy Regimens in Women with Node-Positive Breast Cancer: Docetaxel/Doxorubicin/Cyclophosphamide (TAC); Dose-Dense (DD) Doxorubicin/Cyclophosphamide ? DD Paclitaxel; DD AC ? DD Paclitaxel + Gemcitabine. Phase III. (4, 3/05)
- RTOG 0413
Conventional Whole Breast Irradiation vs. Partial Breast Irradiation for Women with Stage O, I, or II Breast Cancer. Phase II. (0, 7/05)
- RTOG 98-04
DCIS - Good Risk. Obs (+/- Tam) vs. RT (+/- Tam). Phase III. (2, 6/00)
- SWOG S0230
LHRH Analog Administration During Chemo to Reduce Ovarian Failure Following Standard Adjuvant Chemo in Early Stage, Hormone-Receptor Negative Breast Cancer. Phase III. (0, 4/04)
- SWOG S0347
Randomized Study of Wkly Vinorelbine Alone or in Combination with Trastuzumab for Pts. with HER-2 Positive Metastatic Breast Cancer Whose Tumors Have Progressed After Taxane + Trastuzumab Combination Therapy. Phase III. (0, 6/05)
- Sanofi-Aventis 2001
Open-label, Single-arm Study for Metastatic or Locally Advanced and Inoperable Breast Cancer Previously Treated with Anthracyclines, Taxanes, and Capecitabine. Phase II. (0, 11/05)
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CANCER CONTROL
- NSABP Co-Star
Effects of Selective Estrogen Receptor Modulators on Cognitive Aging. (3, 3/04)
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CERVIX
- GOG 204 (6)
Randomized Phase III Study of Paclitaxel Plus Cisplatin vs. Vinorelbine Plus Cisplatin vs. Gemcitabine Plus Cisplatin vs. Topotecan Plus Cisplatin in Stage IVB, Recurrent, or Persistent Carcinoma of the Cervix.
- Bristol
Primary, previously untreated, histologically confirmed, invasive SCC, adeno & adenosquamous; stages 1B-1 through 4A; negative PA nodes; weekly Erbitux/carbo with RT.
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CORPUS UTERUS ENDOMETRIAL
- GOG 209 (6)
Randomized Phase III Trial of Doxorubicin/Cisplatin/Paclitaxel and G-CSF vs. Carboplatin/Paclitaxel in Patients with Stage III and IV or Recurrent Endometrial Cancer
- GOG 181B (3)
A PHASE II EVALUATION OF TRASTUZUMAB (NSC #688097 [MoAb HER2]) IN PATIENTS WITH ADVANCED, RECURRENT OR PERSISTENT ENDOMETRIAL CARCINOMA WITH OR WITHOUT PRIOR CHEMOTHERAPY
- GOG 188 (6)
Phase II Study of Faslodex in Recurrent Endometrial Cancer
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GASTROINTESTINAL
Blumenthal Cancer Center offers some of the most current and innovative Gastrointestinal research studies available in the United States. Patients may participant in in-house, industry or national research group protocols.
- ACOSOG Z9001
Adjuvant Gleevec vs. Placebo for Resected Primary GIST (? 3 cm). Phase III. (1, 1/03)
- CALGB 80101
Intergroup. Adjuvant Chemoradiation after Resection of Gastric or Gastroesophageal Adenocarcinoma. Phase III. (0, 6/03)
- CTSU N0147
CPT-11 or Oxaliplatin + 5-FU/Leucovorin w/or w/o Cetuximab after Curative Resection for Pts with Stage III Colon Cancer. Phase III. (2, 5/04)
- NSABP C-08
Comparison of IV 5-Fluorouracil (5-FU), Leucovorin, and Oxaliplatin (FOLFOX6) Every Two Weeks w/Bevacizumad to the Same Regimen w/o Bevacizumad for Pts with Resected Stages II or III Colon Cancer. Phase III. (1, 2/05)
- NSABP R-04
Preop RT + Capecitabine vs. Preop RT + CVI of 5-FU for Operable Carcinoma of the Rectum. Phase III. (0, 5/05)
- UCCC 03-871
Dose Escalation Study of Body Stereotactic Bypofractionated RT for Liver Mets. Phase I/II. (0, 9/04)
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GENITO-URINARY
- Bayer 11868
Open Label, Non-Comparative Treatment Protocol for the Use of Sorafenib in Patients with Advanced Renal Cell Carcinoma.
(0, 9/05)
- BMS C225093
Intravenous Vinflunine in Pts. with Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium. Phase II. (0, 11/05)
- CALGB 90401
Randomized Double-Blinded Placebo Controlled Trial Comparing Docetaxel and Prednisone with and without Bevacizumab in Men with Hormone Refractory Prostate Cancer. Phase III. (0, 9/05)
- SWOG S0317
OSI-774 for Locally Advanced or Metastatic Papillary Histology Renal Cell Cancer. Phase II. (1, 10/03)
- SWOG S0219
Muscle Invasive, Non-Metastatic Carcinoma of the Bladder w/ Neoadjuvant Gemcitabine, Paclitaxel and Carboplatin w/ Molecular Carrelates. (0, 7/03)
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HEAD AND NECK
Blumenthal Cancer Center gives patients access to some of the most current and innovative research studies available in the United States. Patients may participant in in-house, industry or national research group protocols including:
- CTSU E1302
Randomized, Placebo Controlled, Trial of Docetaxel + ZD 1839 (Iressa, Gefitinib) In Performance Status 2 or Previously Treated Patients w/ Recurrent or Metastatic Head and Neck Cancer. Phase III. (0, 6/05)
- RTOG 0234
Randomized Trial of Surgery ? Chemoradiotherapy + C225 (Cetuximab) for Advanced Squamous Cell Carcinoma of the Head & Neck. Phase II. (0, 10/04)
- Amgen 20020402
Evaluation of Efficacy and Safety of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects w/ Advanced Head and Neck Cancer Receiving Radiotherapy with Concurrent Chemotherapy (RT/CT). Phase III. (0, 3/05)
- DFCI Paradigm
Sequential Therapy w/ TPF/Chemoradiation vs. Cisplatin-based RT for Locally Adv. Squamous Cell Cancer. Phase III. (4, 1/05)
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HEMATOLOGY
Patients at Blumenthal Cancer Center have access to some of the most current and innovative research studies available in the United States. Below are the open protocols available for hematological treatment:
- CALGB 10105B
Oral VEGF Receptor Tyrosine Kinase Inhibitor in Myelodysplastic Syndrome. Phase II. (1, 5/04)
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LEUKEMIA
- CALGB 10101
Fludarbine + Rituximad Induction ? Campath-IH Admin. Subcutaneously as Consolidation in Untreated B-Cell CLL. Phase II. (0, 5/05)
- CALGB 10201
Daunorubicin and Cytarbine ± G3139 for Previously Untreated AML ? 60 Yrs. Phase III. (0, 6/04)
- CALGB 19808
AML < 60 Yr. Induction w/ or w/o PSC833, Intensification by Risk Factors ? R-IL2 vs. Observation. (2, 6/01)
- ECOG E2902
Farnesyl Transferase Inhibitor R115777 for AML in Second or Subsequent Remission or in Remission after Primary Induction Failure. Phase III. (0, 5/05)
- SWOG S0325
Molecular Responses to Imatinib at Standard or Increased Doses for Previously Untreated Pts. w/ CML in Chronic Phases. Phase III. (1, 5/05)
- CALGB 20203
CLL. Companion for 10101. (5, 5/05)
- CALGB 9760
AML. Companion. MDR Studies. (9, 8/97)
- CALGB 8461
AML. Companion for 10102 and 19808. (7, 1/91)
- CALGB 9665
AML. Companion Study for 10102, 10107 and 19808. (11, 9/96)
- CALGB 9862
All. Companion Study for 10102. (0, 11/03)
- CALGB 29801
CML. Companion for 10107. (1, 3/04)
SWOG 9910 Lab and Tissue Repositories. Companion for SWOG S0325.
(0, 5/05)
- SWOG 9007
Cytogenetic companion for SWOG S0325. (0, 5/05)
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LUNG
Patients with lung cancer may participate in a number of regional and national research protocols:
- SWOG S0220
Induction Chemoradiotherapy with Cisplatin/ Etopside ? Surgical Resection ? Docetaxel for NSCLC Involving the Superior Sulcus. Phase II. (0, 10/03)
- SWOG S0222
Tirapazamine/Cisplatin/Etoposide and Concurrent Thoracic Radiotherapy for Limited SCLC. Phase II. (1, 3/04)
- SWOG S9925
Lung Cancer Specimen Respiratory Protocol, Ancillary. (4, 3/04)
- BMS 099
Randomized Multicenter Study of Taxane/Carboplatin/Cetuximab vs. Taxane/Carboplatinas as First-Line Treatment for Pts. w/ Advanced/Metastatic NSCLC. Phase III. (3, 3/05)
- Pfizer 1011
Anti-Angiogensis Agent AG-013736 as Second-Line Treatment for Advanced NSCLC. Phase II. (2, 4/05)
- UCCC 02-721
Stereotactic Body RT for Lung Mets. Phase I/II. (3, 9/04)
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LYMPHOMA
- CALGB 59903
Aggressive NHL, Stage IV. CHOP ? Stem Cell Transplant vs. CHOP Alone. Phase III. (0, 7/00)
- ECOG E4402
Compares Two Different Rituximab Dosing Regimens for Pts w/ Low Tumor Burden Indolent NHL. Phase III. (1, 7/04)
- SWOG E2496
Locally Extensive or Advanced Stage Hodgkin's with 0-2 Risk Factors, ABVD vs. Stanford V+/- RT. (0, 4/00)
- SWOG S0213
Hyper-CVAD and Methotrexate/Ara C + Rituximab in Pts w/ Previously Untreated MCL. Phase II. (1, 5/03)
- SWOG S0349
Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab, or Rituximab and G3139 Phosphorothioate Oligonuleotide (Anti-BCL-2 Antisense Therapy for Pts < Age 60 with Advanced Stage Diffuse Large B-Cell NHL of Low and Low-Intermediate IPI Risk. Phase II. (0, 8/04)
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MELANOMA
Patients with advanced melanoma and kidney cancer may be eligible to participate in a number of regional and national research studies, including:
- CALGB 500101
Yeast Derived GM-CSF vs. Peptide Vaccine vs. GM-CSF + Peptide Vaccine vs. Placebo in Pts w/ NED after Complete Surgical Resection of Locally Advanced and/or Stage IV Melanoma. Phase III. (7, 9/03)
- CALGB 500103
Randomized Study of 4 Wks High Dose IFN-?2? vs. Obs. in Stage T3 - T4 or N1 Microscopic Melanoma. Phase III. (9, 6/03)
- NCI/SBSG
Metastatic Melanoma. HDIL2 + Vaccine vs. HDIL2 Alone. (4, 6/00)
- Luitpold
Taxoprexin Injection vs. Dacarbazine in Pts w/ Metastaticm PO1-02-17 Melanoma. Phase III. (5, 10/04)
- Medarex
Camparison of MDX-010 Monotherapy, MDX-010 + Melanoma Peptide Vaccine, and Melanoma Vaccine Monotherapy in HLA-A*0201-Positive Patients with Previously Treated Unresectable Stage III or IV Melanoma. Phase III. (0, 9/05)
- Onyx 11715
Randomized, Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination with Dacarbazine (DTIC) Chemotherapy in Subjects with Unresectable Stage III or Stage IV Melanoma. Phase II. (0, 7/05)
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MULTIPLE MYELOMA
- Celgene MM-016 Single-Arm, Open-Label Expanded Access Program for Lenalidomide + Dexamethasone in Previously Treated Multiple Myeloma. (0, 9/05)
- Doxil MMY-3001 Randomized Controlled Study of Doxil/Caelyx (doxorubicin HCL liposome injection) and Velcade (bortezomid) or Velcade Monotherapy for Relapsed Multiple Myeloma. Phase III.
(1, 3/05)
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NERVE SHEATH
SWOG S0330 OSI-774 in Malignant Peripheral Nerve Sheath Tumors. Phase II. (0, 9/04)
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PANCREATIC
- CALGB 80303
Randomized Trial of Gemcitabine + Bevacizumab vs. Gemcitabine + Placebo in Pts w/ Advanced Pancreatic Cancer. Phase III. (1, 1/05)
- RTOG 0411
Study of Bevacizumab + Concurrent Capecitabine and Radiation ? Maintenance Gemitabine and Bevacizumab for Locally Advanced Pancreatic Cancer. Phase II. (0, 6/05)
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OVARIAN
- GOG 212 (6)
Randomized Phase III Trial of Maintenance chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or Xyotax vs. No Treatment Until Documented Relapse in Women with Advanced Ovarian or Primary Peritoneal Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy
- GOG 187 (3)
Phase II Study of Paclitaxel for Ovarian Stromal Tumors as First-Line or Second-Line Therapy.
- GOG 126Q (3)
Phase II Study of 3-AP and Cisplatin in Patients With Recurrent or Persistent Platinum-Resistant Ovarian Epithelial or Primary Peritoneal Cancer
- GOG 190 (6)
Randomized Study of Fenretinide as Chemoprevention in Patients at Increased Risk for Ovarian Cancer
- GOG 198 (6)
A randomized study of Tamoxifen versus Thalidomide in patients with biochemical recurrence only epitherial ovarian cancer. Cancer of the fallopian tube, and primary peritoneal carcinoma after first line chemotherapy
- GOG 199 (6)
Prospective study of risk-reducing salpingo-oophorectomy and longitudinal CA-125 screening among women at increased genetic risk of ovarian cancer.
- GOG 175 (6)
Randomized Phase III trial of Carboplatin and Paclitaxel plus weekly low dose Paclitaxel versus IV Carboplatin and Paclitaxel and observation in patients with early stage ovarian carcinoma
- Lilly S302
Phase III Randomized Trial of Induction Chemotherapy with Gemcitabine
- DUMC 03
A Multicenter, Randomized, Phase III Comparative Study to Compare the Efficacy and Safety of Taxotere/Carboplatin Combination Therapy Versus Sequential Therapy with Taxotere then Carboplatin as Second-Line Treatment of Patients with Relapsed, Platinum-Sensitive Ovarian Cancer
- Ova Rex
Stage III/IV ovarian, FT, prim. Peritoneal; microscopic dz or residual no greater than 2 cm at debulking surgery; high CA-125 prior to surgery or CA-125 greater than or equal to 100 & tumor expresses CA-125; CR (CT, PE, CA-125, CXR) s/p taxane & platinum cmpd, no more than 8 cycles; OvaRex versus placebo IV q 4 weeks x 11 or until dz relapse.
- GSK 902
Potentially platinum-sensitive, ovarian, FT, primary peritoneal, weekly topotecan & carbo, 2 out of 3 weeks (waiting for Phase II to open)
- Telik 3024
A Phase III, Randomized Study of TLK286 (TelcytaTM) in Combination with Carboplatin (Paraplatin®) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer.
- Genentech
recurrent, platinum resistant ovarian, FT or primary peritoneal; 2nd line, measurable or evaluable; gemzar plus pertuzumab versus gemzar plus placebo; for progression, crossover to pertuzumab if receiving placebo
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PHASE I
- Aventis 1001
Dose-Escalation, Sequential-Cohort Study of the Safety,
- VEGF Trap
Tolerability, and Pharmacokinetics of IV AVE0005A + IV
- FOLFOX
Administered Every 2 Wks for Advanced Solid Tumors. Phase I. (1, 7/05)
- Synta 5312-01
STA-5312 on Alternate Weekdays Every Two Wks for Hematological Malignancies and Solid Tumors. Phase I. (2, 3/04)
- Synta 5312-02
STA-5312 Once Wkly for Advanced/Metastatic Solid Tumors. Phase I. (8, 7/04)
- Roche NP18378
Multiple Ascending Dose Study of the CDK Inhibitor RO4584820 Administered as an IV Infusion on a Wkly Schedule in Pts w/Advanced Solid Tumors. Phase I. (1, 7/05)
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PROSTATE
The following research protocols are available for the treatment of prostate cancer:
- RTOG 0232
Combined External Beam RT and Transperineal Interstitial Permanent Brachytherapy vs. Brachytherapy Alone for Immediate Risk Prostatic Cancer. Phase I/II. (1, 3/04)
- SWOG 9921
Adjuvant Androgen Deprivation vs. Mitoxantrone + Predisone + Androgen Deprivation in Selected High Risk Prostate Cancer Pts Following Radical Prostatectomy. Phase III. (0, 05/05)
McKay Urology
- Dendreon D9902B
Immunotherapy with Autologous Antigen-Presenting Cells Loaded with PA2024 (Provenge™, APC8015) in Asymptomatic Pts with Gleasone Sum ? 7, Metastatic, Androgen Independent Prostatic Adenocarcinoma. Phase III.
- Dendreon PB01
Immunotherapy with Autologous Antigen Presenting Cells Loaded with PA2024 (APC-8015F) for Subjects with Objective Disease Progression and Disease-Related Pain on Protocol D9902B.
- GTx G300104
Efficacy and Safety Study of Toremifene Citrate for the Prevention of Prostate Cancer in Men with High Grade Prostatic Intraepithelial Neoplasia.
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SARCOMA
- ACOSOG Z9031
Preoperative RT + Surgery vs. Surgery Alone for Pts w/ Retroperitoneal Sarcomas. Phase III. (0, 12/04)
- RTOG 0330
Pre-operative RT + Thalidomide for Low Grade Primary Soft Tissue Sarcoma or Pre-Operative MAID/Thalidomide/RT for High/Intermediate Grade Primary Soft Tissue Sarcoma of the Extremity or Body Wall. Phase II. (1, 2/05)
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STEM CELL
- CALGB 100104
Randomized, Double-Blind Study of Maintenance Therapy with CC-5013 or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma. Phase III. (0, 5/05)
- CALGB 50205
Rituximab and Autologous Stem Cell Transplantation for B Cell Diffuse Large Cell Lymphoma. Phase III. (0, 7/05)
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TROPHOBLASTIC
- GOG 217 (3)
Persistent, recurrent low risk post molar GTT; 2nd line, Pemetrexed q 3 weeks
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UTERINE SARCOMA
- GOG 230B (6)
A Phase II Evaluation of Thalidomide in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus
- GOG 130 E (3)
A Phase II Evaluation of Gemcitabine and Docetaxel in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus
- GOG 131G (6)
Phase II Evaluation of Docetaxel and Gemcitabine Plus G-CSF in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
- GOG 232B (3)
Paclitaxel & Carboplatin in the treatment of adv, persistent, or recurrent uterine carcinosarcoma
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VULVA
- GOG 205 (3)
Phase II Trial of Radiation Therapy and Weekly Cisplatin Chemotherapy for the Treatment of Locally Advanced Squamous Cell carcinoma of the Vulva
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