Open Protocols

Hematology Oncology, P.C./Bennett CancerCenter

Primary

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Disease Stage

/

Protocol

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Title

Bone Mets. With
Advanced Cancer
or Multiple
Myeloma / Solid tumor stage IV or any stage multiple myeloma / Amgen 20050244
DP - Sue / “A Randomized, Double-Blind, Multicenter Study of Denosumab Compared with Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma” (Phase III)
Breast / Met or locally advanced / Amgen 20060341
PW – Mary / “A Randomized, 4-Arm, Placebo-Controlled Phase 2 Trial of AMG 386 in Combination with Bevacizumab and Paclitaxel or AMG 386 plus Paclitaxel as First-Line Therapy in Subjects with Her2-Negative, Metastatic or Locally Recurrent Breast Cancer”
Breast / I-II / ECOG 5103
DP - Mary / “A Double-Blind 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 / Stage I-II with negative lymph nodes / ECOG PACCT-1
PW - Mary / “Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The Tailorx Trial” (Phase III)
Breast / III / IBCSG 24-02
SOFT
IT - Kathy / “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 / I-IIIA / NSABP B-42
PW - Mary / “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”(Phase III)
Carcinoid Tumors / Advanced / Novartis CRAD001C2325
DP - Kathy / “A Randomized, double-blind, placebo-controlled, multicenter phase III study in patients wit advanced carcinoid tumor receiving Sandostatin LAR and RAD001 10mg/d or Sandostatin LAR and placebo”
Digestive
System/GI
Colon or Rectum / IV / CALGB 80405
DP - Ed / “A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum”
Digestive Systems/GI
Colon / III / NCCTG N0147
DP – Ed / “A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer”
Digestive
System/GI
Colon / II / E5202
DP – Ed / “A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 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”
Digestive
System/GI
Rectal / II or III / E5204
DP – Ed / “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”
Digestive System/GI
Pancreas / IV / Imclone CP02-0555
DP – Ed / “A Phase II, Randomized, Open-Label Study of Cetuximab and Bevacizumab Alone or in Combination with Fixed-Dose Rate Gemcitabine as First-Line Therapy of Patients with Metastatic Adenocarcinoma of the Pancreas”
Genitourinary/GU
Kidney / IV lower intermediate risk / Amgen 20060159
DP – Sue / A Randomized, Double Blinded, Multicenter Phase 2Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Sorafenib in Combination with AMG 386 or Placebo in Subjects with Metastatic Clear Cell Carcinoma of the Kidney
GYN
Ovarian, Fallopian or Primary Peritoneal CA / Advanced / Covance NV06-0039DP – Sue / Multi-Center, Randomized, Double-Blind, Phase III Efficacy Study Comparing Phenoxodiol (Oral Dosage Form) in Combination with Carboplatin versus Carboplatin with Placebo in Patients with Platinum-Resistant or Platinum-Refractory Late-Stage Epithelial Ovarian, Fallopian or Primary Peritoneal Cancer Following at Least Second Line Platinum Therapy
GYN
Ovary, Peritoneal, Fallopian Tube / Advanced / Genentech AVF4095gOCEANS
DP –Sue / “A Phase II, Multicenter, Randomized, Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients with Platinum-sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma”
GYN
Ovarian, Primary Peritoneal / Advanced / GOG 0218DP –Sue / “A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC #704865, IND #7921) Followed by Placebo, versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women with Newly Diagnosed, Previously Untreated, Suboptimal Advanced Stage Epithelial Ovarian and Primary Peritoneal Cancer “
Lymphoma
NHL / Any / J&J 26866138-LYM-3001
NC – Kathy / “A Randomized, Open-Label, Multicenter Study of VELCADE with Rituximab or Rituximab Alone in Subjects with Relapsed or Refractory, Rituximab Naïve or Sensitive Follicular B-Cell Non-Hodgkin’s Lymphoma” (Phase III)
Multiple Myeloma / Keryx Perifosine 218
MB - Sue / “An Open-Label, Phase I/II Study of the Safety and Efficacy of Perifosine and Bortezomib with or without Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma Previously Treated with Bortezomib”
Multiple Site NSCLC, Breast
(The CRC portion closed to accrual1/24/08) / IV / Genentech AVF3991n
ARIES
DP - Ed / “An Observational Study of Avastin (Bevacizumab) in Combination with Chemotherapy for Treatment of Metastatic or Locally Advanced and
Unresectable Colorectal Cancer, Locally Advanced or Metastatic Non-Small Cell Lung (Excluding Predominant Squamous Cell Histology), or Locally Recurrent or Metastatic Breast Cancer”
Note: Effective 1/24/08 the CRC portion of this study is closed to accrual.
Pulmonary/Lung
NSCLC / IIIB, IV /

Amgen 20060136

DP – ED / “A Phase 2, Multicenter, Open-label, Randomized Trial of AMG 706 or Bevacizumab in Combination with Paclitaxel and Carboplatin for Advanced Non-Squamous Non-Small Cell Lung Cancer”
Pulmonary/Lung
NSCLC / IIIA/B /

Dartmouth Hitchcock D0410

DP - Ed / “A National Web-Based Randomized Phase III Study of Erlotinib or Placebo Following concurrent Docetaxel, Carboplatin and Thoracic Radiotherapy in Patients with Inoperable Stage III Non-Small Cell Lung Cancer”
Pulmonary/Lung
NSCLC / Adjuvant
IB-IIIA /

E1505

DP - Ed / “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 (NSCLC)”
Pulmonary/Lung
NSCLC / Observational /

Lilly H3E-US-B001

DP -Mary / “Non-Small Cell Lung Cancer: The Impact of Ethnic Origin on Patients being Treated Second Line with Pemetrexed – an Observational Study”
Pulmonary/Lung
NSCLC / IB-IIIA /

OSI-774-302

RADIANT
DP - Kathy / “A Multicenter, Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Single-agent Tarceva (erlotinib) Following Complete Tumor Resection with or without Adjuvant Chemotherapy in Patients with Stage IB-IIIA Non-Small Cell Lung Carcinoma who have EGF-positive Tumors”
Pulmonary/Lung
SCLC / Metastatic /

Ascenta AT-101-CS-101

DP - Ed
Phase II only. / “An Open-Label, Multicenter, Phase I/II Study of AT-101 in Combination with Topotecan in Patients with Relapsed or Refractory Small Cell Lung Cancer After Prior Platinum Containing First Line Chemotherapy”
Pulmonary/Lung
SCLC / Extensive /

Genentech AVF3995g

SALUTE

DP - Ed

/ “A Placebo-Controlled, Double-Blind, Multicenter, Randomized, Phase II Study of Bevacizumab in Previously Untreated Extensive-Stage Small Cell Lung Cancer”
Skin Cancer
Melanoma / T3 – T4 or N1 / E1697
DP - Mary / “A Phase III Randomized Study of Four Weeks High Dose IFN-a2b in Stage T2b N0, T3a-b, T4a-b N0, and T1-4, N1a, 2a, 3 (microscopic) Melanoma.”

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