CCRP: Clinical Trials

CLINICAL TRIALS

What is a Clinical Trial?

Why are Clinical Trials Important?

What Types are Available?

How are Trials Tested?

Where are Trials Conducted?

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  Colorado Cancer
  Research Program

  2253 South Oneida St.
  Third Floor, Suite B
  Denver, CO 80224

  Phone: 303.777.2663
  Fax: 303.777.2642
  Toll-free: 888.785.6789

Disease Site	Disease SubType	Protocol Number	Title & Description
BREAST	Adjuvant	24-02 (SOFT) (CTSU/IBCSG)	Title: LIMITED PHYSICIANS ONLY A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer
BREAST	Adjuvant	40101 (CTSU/CALGB)	Title: Cyclophosphamide and Doxorubicin (CA x 4 Cycles) Versus Paclitaxel (4 Cycles) As Adjuvant Therapy For Breast Cancer in Women with 0-3 Positive Axillary Lymph Nodes: A Phase III Randomized Study.
BREAST	Adjuvant	B-37 (NSABP)	Title: A Randomized Clinical Trial of Adjuvant Chemotherapy for Radically Resected Loco-Regional Relapse of Breast Cancer.
BREAST	Adjuvant	B-39 (NSABP)	Title: CLOSED to Accrual 12/30/06 for patients >/= 50 years of age w/ DCIS regardless of hormone recepter status; and Invasive breast cancer who meet all criteria, >/= 50 yrs old and node negative and hormone receptor postive. STUDY LIMITED TO COLO SPGS, PUEBLO, RMCC THORNTON, AURORA, RMCC SKY RIDGE, PORTER, BOULDER, RMCC MIDTOWN, SWEDISH, LOVELAND, GREELEY & LITTLETON SITES ONLY A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) vs. Partial Breast Irradiation (PBI) for Women with Stage 0, I or II Breast Cancer.
BREAST	Adjuvant	B-42 (NSABP)	Title: TENTATIVE CLOSURE - Registration Program on 09/05/08 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.
BREAST	Adjuvant	E5103 (ECOG)	Title: A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer.
BREAST	Adjuvant	MA.17R (ECOG/NCIC CTG)	Title: LIMITED TO PATIENTS THAT ARE ON JMA.17 A Double Blind Randomization to Letrozole or Placebo for Women Previously Diagnosed with Primary Breast Cancer Completing Five Years of Adjuvant Aromatase Inhibitor Either as Initial Therapy or After Tamoxifen. (including those in the JMA.17 study)
BREAST	Adjuvant	N063D (CTSU/NCCTG)	Title: ALTTO: Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation Study: A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients with HER2/ErbB2 Positive Primary Breast Cancer.
BREAST	Adjuvant	PACCT-1 (ECOG)	Title: Program for the Assessment of Clinical Cancer Tests - Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial.
BREAST	Metastatic	E1105 (ECOG)	Title: 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.
BREAST	Neo Adjuvant	B-40 (NSABP)	Title: 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.
BREAST	Neo Adjuvant	B-41 (NSABP)	Title: LIMITED PHYSICIANS ONLY A Randomized Phase III Trial of Neoadjuvant Therapy for Patients with Palpable and Operable HER2-Positive Breast Cancer Comparing the Combination of Trastuzumab Plus Lapatinib to Trastuzumab and to Lapatinib Administered with Weekly Paclitaxel Following AC Accompanied by Correlative Science Studies to Identify Predictors of Pathologic Complete Response.
BREAST	Neoadjuvant & Adjuvant	FB-5 (NSABP FRP)	Title: LIMITED PHYSICIANS ONLY A Phase II Clinical Trial of Epirubicin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Bevacizumab Given as Neoadjuvant Therapy for HER2-Positive Locally Advanced Breast Cancer or Given as Adjuvant Therapy for HER2-Positive Pathologic Stage III Breast Cancer.
CANCER CONTROL	Cancer Control Lung	E5597 (ECOG)	Title: Phase III Chemoprevention Trial of Selenium Supplementation in Persons with Resected Stage I Non Small Cell Lung Cancer
CANCER CONTROL	Malignant Ascites	N04C2 (NCCTG)	Title: An Exploratory, Randomized, Placebo-Controlled Trial of Depot Octreotide (Sandostatin LAR ® Depot) for Symptomatic Ascites in Cancer Patients.
CANCER CONTROL	Ovarian	GOG-0215 (GOG)	Title: LIMITED PHYSICIANS ONLY A Phase II Randomized Study of the Effect of Zoledronic Acid versus Observation on Bone Mineral Density of the Lumbar Spine in Women who Elect to Undergo Risk-Reducing Surgery that Results in Removal of Both Ovaries.
CANCER CONTROL (any site)	Cancer Control	N05C5 (NCCTG)	Title: A Phase III Randomized, Placebo-controlled, Double-blind Trial to Determine the Effectiveness of a Urea/Lactic Acid-Based Topical Keratolytic Agent and Vitamin B-6 for Prevention of Capecitabine-Induced Hand and Foot Syndrome.
CANCER CONTROL (any site)	Vaginal Dryness	N04CA (NCCTG)	Title: Pilocarpine for Vaginal Dryness: A Phase III Randomized, Double-Blind, Placebo-Controlled Study.
GASTRO-INTESTINAL	Adjuvant	E5202 (ECOG)	Title: 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.
GASTRO-INTESTINAL	Gastric	80101 (CTSU/CALGB)	Title: Phase III Intergroup Trial of Adjuvant Chemoradiation After Resection of Gastric or Gastroesophageal Adenocarcinoma
GASTRO-INTESTINAL	Rectal	E5204 (ECOG)	Title: 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.
GASTRO-INTESTINAL	Rectal	R-04 (NSABP)	Title: A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with Preoperative Radiation Therapy and Continuous Intravenous Infusion (CVI) of 5-Fluorouracil (5-FU) in the Treatment of Patients with Operable Carcinoma of the Rectum.
GENITO-URINARY	Ovarian	GOG-0212 (GOG)	Title: LIMITED PHYSICIANS ONLY A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or CT-2103 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.
GENITO-URINARY	Ovarian	GOG-0218 (GOG)	Title: A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo vs Carboplatin and Paclitaxel Plus Concurrent Bevacizumab Followed By Placebo, Vs Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, In Women With Newly Diagnosed, Previously Untreated, Stage III or IV Epithelial Ovarian or Primary Peritoneal Cancer.
GENITO-URINARY	Prostate	0415 (CTSU/RTOG)	Title: LIMITED SITES ONLY A Phase III Randomized Study of Hypofractionated 3D-CRT/IMRT Versus Conventionally Fractionated 3D-CRT/IMRT in Patients Treated for Favorable-Risk Prostate Cancer.
GENITO-URINARY	Prostate	0521 (CTSU/RTOG)	Title: LIMITED SITES ONLY A Phase III Protocol of Androgen Suppression (AS) and 3DCTR/IMRT vs AS and 3DCTR/IMRT Followed by Chemotherapy With Docetaxel and Prednisone for Localized, High-Risk, Prostate Cancer.
GENITO-URINARY	Prostate	E3803 (ECOG)	Title: Reopen to Accrual for Two Prior Cytotoxic Chemotherapies Stratum with measurable disease ONLY as 05/07/08. Phase II Study of a Weekly Schedule of BMS-247550 for Patients with Hormone Refractory Prostate Cancer
GENITO-URINARY	Prostate	S0421 (CTSU/SWOG)	Title: Phase III Study of Docetaxel and Atrasentan versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer.
GENITO-URINARY	Prostate	S9346 (ECOG)	Title: TENTATIVE CLOSURE 09/01/08 Phase III Study of Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer
GENITO-URINARY	Renal	E2804 (ECOG)	Title: The BEST Trial: A Randomized Phase II Study of VEGF, RAF kinase and mTOR Combination Targeted Therapy (CTT) with Bevacizumab, Sorafenib and Temsirolimus in Advanced Renal Cell Carcinoma.
GENITO-URINARY	Renal	E2805 (ECOG)	Title: ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma.
GENITO-URINARY	Renal	E4805 (ECOG)	Title: A Randomized Phase II Study to Determine the Effect of 2 Different Doses of AVE0005 (VEGF Trap) in Patients with Metastatic Renal Cell Carcinoma.
HEAD & NECK	Head & Neck	04-006 (Dana Farber)	Title: STUDY PHYSICIANS ONLY A Randomized Phase III Trial Comparing Sequential Therapy With TPF/Chemoradiation (ST) To Cisplatin-Based Chemoradiotherapy with Accelerated Concimitant Boost Radiotherapy (CRT) for Locally Advanced Squamous Cell Cancer of the Head and Neck.
HEAD & NECK	Head & Neck	0522 (CTSU/RTOG)	Title: LIMITED SITES ONLY A Randomized Phase III Trial of Concurrent Accelerated Radiation and Cisplatin Versus Concurrent Accelerated Radiation, Cisplatin, and Cetuximab (C225) [Followed by Surgery for Selected Patients] for Stage III and IV Head and Neck Carcinomas.
HEAD & NECK	Head & Neck	E1302 (ECOG)	Title: Arm C Suspended 07/11/07 Phase III, Randomized, Placebo-Controlled Trial of Docetaxel Vs Docetaxel Plus ZD1839 (Iressa) In Performance Status 2 or Previously Treated Patients With Recurrent or Metastatic Head and Neck Cancer.
LEUKEMIA	AML	E1900 (ECOG)	Title: A Phase III Trial in Adult Acute Myeloid Leukemia: Daunorubicin Dose-Intensification Prior to Risk-Allocated Autologous Stem Cell Transplantation.
LEUKEMIA	AML	E2902 (ECOG)	Title: A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia (AML) Patients in Second or Subsequent Remission or in Remission After Primary Induction Failure or Patients over Age 60 in First Remission.
LEUKEMIA	CLL	10501 (CTSU/CALGB)	Title: A Phase III Intergroup CLL Study of Asymptomatic Patients with Untreated Chronic Lymphocytic Leukemia Randomized to Early Intervention Versus Observation with Later Treatment in the High-Risk Genetic Subset with IGVH Unmutated Disease.
LEUKEMIA	CLL	E2903 (ECOG)	Title: Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) followed by Campath-1H for Previously Treat Relapsed or Refractory Patients with Chronic Lymphocytic Leukemia.
LEUKEMIA	Large Granular Lymphocytic	E5998 (ECOG)	Title: Phase II Study of Initial Treatment with Methotrexate in Large Granular Lymphocytic (LGL) Leukemia.
LEUKEMIA	MDS, CMML, AML	E1905 (ECOG)	Title: A Randomized Phase II Trial of Azacitadine With or Without the Histone Deacetylase Inhibitor MS-275 for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocyic Leukemia (dysplastic type) and Acute Myeloid Leukemia with Multilineage Dysplasia.
LUNG	Advanced Bronchioalveolar Carcinoma (BAC)	E1504 (ECOG)	Title: Phase II Study of C225 (Cetuximab) for the Treatment of Patients with Advanced Bronchioalveolar Carcinoma (BAC) or Adenocarcinoma with BAC Features.
LUNG	Non Small Cell	0617 (CTSU/RTOG)	Title: LIMITED SITES ONLY - A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer.
LUNG	Non Small Cell	E1505 (ECOG)	Title: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4 cm) – IIIA Non-Small Cell Lung Cancer (NSCLC).
LUNG	Non Small Cell	N0626 (NCCTG)	Title: Phase II Randomized Study Pemetrexed with Sorafenib versus Pemetrexed Alone as Second-line Therapy in Patients with Advanced Non-Small Cell Lung Cancer.
LYMPHOMA	Diffuse Large Cell NHL	E3402 (ECOG)	Title: LIMITED PHYSICIANS ONLY A Phase II Trials of R-CHOP Followed By Zevalin Radioimmunotherapy For Patients with Preciously Untreated Stages I and II CD20+ Diffuse Large Cell Non-Hodgkin’s Lymphoma.
LYMPHOMA	Hodgkin's and Non-Hodgkin's	114-NH-301 (Biogen Idec)	Title: LIMITED SITES ONLY A Phase III, Randomized, Double-Blind Study of Galiximab in Combination with Rituximab Compared with Rituximab in Combination with Placebo for the Treatment of Subjects with Relapsed or Refractory, Follicular Non Hodgkin’s Lymphoma.
LYMPHOMA	Mantle Cell Lymphoma	E1405 (ECOG)	Title: A Phase II Study of VcR-CVAD with Rituximab Maintenance for Untreated Mantle Cell Lymphoma.
LYMPHOMA	Mantle Cell Lymphoma	N038H (NCCTG)	Title: Phase II Study of CCI-779 in Combination with Rituximab in Patients with Relapsed or Refractory Mantle Cell Lymphoma.
LYMPHOMA	Non-Hodgkin's Lymphoma	E4402 (ECOG)	Title: TENTATIVE CLOSURE TO ACCRUAL 09/12/08 Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens for Patients with Low Tumor Burden Indolent Non-Hodgkin’s Lymphoma
MELANOMA	Melanoma	E1697 (ECOG)	Title: Phase III Randomized Study of Four Weeks High Dose IFN-á2b in Stage T2b No, T3a-b No, T4a-b No, and T1-4, N1a, 2a, 3 (microscopic) Melanoma.
MELANOMA	Metastatic	N0675 (NCCTG)	Title: A Phase II Study of Temozolomide and Everolimus (RAD001) Therapy for Metastatic Melanoma.
MYELOMA	Multiple Myeloma	10104 (ECOG/CALGB)	Title: A Phase III Randomized, Double-Blind Study of Maintenance Therapy With CC-5013 or Placebo Following Autologous Stem Cell Transplantation For Multiple Myeloma.
MYELOMA	Multiple Myeloma	E1A05 (ECOG)	Title: Randomized Phase III Trial of Consolidation Therapy with Bortezomib (Velcade®) - Lenalidomide (Revlimid®) -Dexamethasone (VRD) versus Bortezomib (Velcade®) -Dexamethasone (VD) for Patients With Multiple Myeloma Who Have Completed a Dexamethasone Based Induction Regimen.