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Clinical Trials Monthly - May 2013

Each month we publish this newsletter with our Hotlist of the newest clinical trials that might be of interest to you and your patients. In this issue, we feature trials for colorectal cancer, ovarian cancer, and renal cell carcinoma.

Colorectal Cancer Ovarian Cancer
Renal Cell Carcinoma

Median Overall Survival in Stage IV Colorectal Cancer Patients with Complete Response Reaches 92.7 Months in ADAPT Trial

Announced last summer with prominent press coverage, the ADAPT (activating dormancy and priming targeting) trial for metastatic colon cancer treatment is finally open at Seattle Cancer Care Alliance (SCCA).

This is the first study to target colorectal cancer stem cells. Dormant cancer stem cells are the suspected culprit behind colorectal cancer treatment failure. Led by SCCA medical oncologist Edward Lin, MD, and funded by Gateway for Cancer Research, the ADAPT study uses a combination therapy of capecitabine (chemotherapy) and celecoxib, an approved arthritis medication. The rationale is to activate stem cells out of dormancy, giving the chemotherapy enough time to complete its job. Pilot studies revealed significant survival rate increases when compared to conventional therapy.

“A lot of patients we didn’t expect to see live are living and thriving,” says Lin of patients he has been treating with this new combination therapy. The treatment is “offering an immediate benefit to today’s cancer patients,” he says. “Ninety-five percent of participants are out and about in their daily lives, doing what they need to do without skipping a beat.”

It is open to a broad range of patients with varying stages of colorectal cancer. Other promising trials are highlighted as well.
 

Colorectal Cancer

Capecitabine and Celecoxib w/wo Radiation Therapy for Colorectal Cancer Patients Previously Treated With Fluorouracil (ADAPT - 7707)

A Phase II Trial of Maintenance ADAPT Therapy with Capecitabine and Celecoxib in Patients with Metastatic Colorectal Cancer

The objective of this trial is to determine the rate of complete response (CR) two years after initiating first-line 5-FU-based chemotherapy with ADAPT therapy in patients with metastatic colorectal cancer.

Growing evidence indicates that a leading cause of treatment failure is cancer stem cells (CSCs), which are cancer-initiating cells that are resistant to conventional chemotherapy and radiation therapy. An SCCA leukemia investigation suggests that “dormant” CSCs can be experimentally activated in a way that makes them susceptible to chemotherapy. These observations provided the foundation for a new strategy to treat cancers by activating CSCs from dormancy to prime them for subsequent targeting.

The ADAPT therapy protocol includes capecitabine, a 5FU prodrug, and celecoxib. SCCA researchers found this combination therapy led to a complete response (CR) in 54 of 124 patients (43 percent) with stage IV unresectable colorectal cancers. Median overall survival in patients who achieved CR has now reached 92.7 months. Investigator: Edward Lin, MD


Ovarian Cancer

EP-100 Plus Paclitaxel Versus Paclitaxel Alone for Ovarian Cancer (7685)

EP-100, a Novel LHRH Receptor-Targeted, Membrane-Disrupting Peptide, Plus Paclitaxel Versus Paclitaxel Alone for Refractory or Recurrent Ovarian Cancer: a Phase II Randomized, Multicenter Trial

This study will determine the safe and effective dose of the investigational drug EP-100, a synthetic, luteinizing hormone releasing hormone (LHRH) peptide that is conjugated to a cytolytic peptide when given in combination with paclitaxel, a U.S. Food and Drug Administration (FDA)-approved chemotherapy for refractory or recurrent ovarian cancer. This combination has only been tested in the laboratory and in animals. Many cancer cells overexpress LHRH receptors and EP-100 is designed to target these tumors. Only patients with histologic evidence of LHRH-receptor expression who have already tried standard therapies will be enrolled.

There are two phases to this trial. In the first dose-finding phase, low-dose EP-100 will be given with a standard dose of paclitaxel. Doses of EP-100 will be incrementally increased in new enrollees as tolerated. The second phase will determine anti-tumor effects and safety, and will enroll two groups of people: one at the standard weekly dose of paclitaxel and the other with this dose plus twice-weekly EP-100. 

This trial is being offered at the following SCCA Network sites: Bozeman Deaconess Cancer Center, Columbia Basin Hematology & Oncology, Group Health Medical Centers, MultiCare Regional Cancer Center, Skagit Valley Hospital, and Wenatchee Valley Medical Center. Investigator: Renata Urban, MD

EC145 in Combination with Doxil® for Platinum-Resistant Ovarian Cancer (7334)

A Randomized Double-Blind Phase III Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (Pld/Doxil®/Caelyx®) in Combination Versus PLD in Subjects with Platinum-Resistant Ovarian Cancer

This study will test the investigational conjugate drug EC145 (folate, the B vitamin, linked to vinca, the chemotherapy) in combination with FDA-approved drugs Doxil/Caelyx in women whose ovarian cancer worsened or recurred in six months or less.

Ovarian cancer cells tend to have a high number of folate receptors and demand more folate than normal cells. By combining vinca with folate, researchers hope the folate-hungry cancer cells will take up the conjugate and then release the vinca, causing cancer cell death.

This study will also use an experimental radioactive imaging scan called a FolateScan (99mTc-EC20) to see which cells are more likely to “grab” EC145. This is a noninvasive test using Single Photo Emission Computed Tomography (SPECT) scan.

This trial is being offered at the following SCCA Network sites: Bozeman Deaconess Cancer Center, Group Health Medical Centers, and MultiCare Regional Cancer Center. Investigator: Barbara Goff, MD

Renal Cell Carcinoma

BNC105P w/ Everolimus for Metastatic Clear Cell Renal Cell Carcinoma (7712)

Phase I/II Study of BNC105P in Combination with Everolimus or Following Everolimus for Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine Kinase Inhibitors

This study will test the experimental cancer drug BNC105P in combination with everolimus. BNC105P targets the blood vessels that supply tumor cells, reducing blood flow to the tumor and leading to reduced oxygen and nutrient supply. Different from other drugs with vascular mechanisms, BNC105P also “locks itself” inside the tumor cell and has direct antiproliferative effects. Cancer cells starved of oxygen often react by upregulating a signaling pathway called mTOR. Thus, researchers are also administering BNC105P with an mTOR inhibitor, everolimus, to combat this tumor survival response.

In this study, the researchers’ goal is to see if treatment with BNC105P and everolimus at the same time is better than treatment with everolimus first, then with BNC105P after everolimus stops working. Everolimus is approved by the FDA to treat kidney cancer following treatment with chemotherapies like sunitinib or sorafenib.

The Phase I study determined the dosage of BNC105P to be given – the highest was 16mg/m2. This Phase II study will enroll 134 subjects in the United States and Australia. 

This trial is being offered at the following SCCA Network sites: Bozeman Deaconess Cancer Center, Columbia Basin Hematology & Oncology, Group Health Medical Centers, MultiCare Regional Cancer Center, and Olympic Medical Cancer Center. Investigator: Shailender Bhatia, MD

Trials Hotlist

NCI Designation

Disease Site

Description

NCT01439347

ALL

A Phase III, Multicenter, Randomized Study to Evaluate the Substitution of Marqibo® (Vincristine Sulfate Liposomes Injection, VSLI) for Standard Vincristine Sulfate Injection (VSI) in the Induction, Intensification, and Maintenance Phases of Combination Chemotherapy in the Treatment of Subjects = 60 Years Old with Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

NCT01565668

AML

A Phase II, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects with FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

NCT01701323

AML

Pilot Study Evaluating the Use of Ex Vivo Expanded Cord Blood Progenitors as Supportive Care Following Induction Chemotherapy (FLAG) in Patients with Relapsed/Refractory AML

NCT01696084

AML

Phase III, Multicenter, Randomized Trial of CPX-351 (Cytarabine: Daunorubicin) Liposome Injection versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age with Untreated High Risk (secondary) AML 

NCT01729845

AML/MDS

Mitoxantrone, Etoposide, and Cytarabine (MEC) Following Epigenetic Priming with Decitabine in Adults with Relapsed/Refractory Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS): A Phase I/II Study 

NCT00626990

Brain Cancer

Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1P/19Q Deleted Anaplastic Glioma: The CATNON Intergroup Trial (RTOG 0834) 

NCT01492101

Breast Cancer

The BEACON Study (Breast Cancer Outcomes with NKTR-102): A Phase III Open-Label, Randomized, Multicenter Study of NKTR-102 versus Treatment of Physician’s Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline, a Taxane, and Capecitabine 

NCT01720602

Breast Cancer

A Pilot Study of Vorinostat to Restore Sensitivity to Aromatase Inhibitor Therapy Part B 

NCT01650805

CML

A Phase III Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase 

NCT01729923

Colorectal Cancer

A Phase II Trial of Maintenance ADAPT Therapy with Capecitabine and Celecoxib in Patients with Metastatic Colorectal Cancer

NCT01479465

Colorectal Cancer

A Phase II Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined with FOLFIRI as Second-Line Treatment for Metastatic KRAS Mutant Colorectal Adenocarcinoma that has Progressed Following a First-Line Oxaliplatin-and Fluoropyrimidine-Containing Regimen

NCT01609231

Colorectal Cancer

A Phase IIA Open-Label, Adaptive, Randomized Clinical Trial of Dalotuzumab (MK-0646) Treatment in Combination with Irinotecan versus Cetuximab and Irinotecan for Patients with Metastatic Rectal Cancers (mRC) Expressing High IGF-1/Low IGF-2 Levels 

NCT01642082

Endometrial Cancer

A Phase II Evaluation of Dalantercept, A Novel Soluble Recombinant Activin Receptor-Like Kinase 1 (ALK-1) Inhibitor Receptor-Fusion Protein, in Treatment of Recurrent or Persistent Endometrial Carcinoma 

NCT01196390

Esophageal Cancer

A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma

NCT01333033

Esophageal Cancer

Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer 

NCT01498328

Glioblastoma

A Phase II Study of Rindopepimut/GM-CSF in Patients with Relapsed EGFRvIII-Positive Glioblastoma

NCT01091428

Gynecologic Cancers

Randomized Phase II Study of MLN8237, an Aurora A Kinase Inhibitor, Plus Weekly Paclitaxel or Weekly Paclitaxel Alone in Patients with Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, Preceded by a Phase I Portion in Patients with Ovarian or Breast Cancer 

NCT01412229

Head & Neck Cancer

A Phase II Study of Carboplatin, Nab-Paclitaxel and Cetuximab for Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck 

NCT01690520

Leukemia

Multicenter, Open-Label Randomized Study of Single or Double Myeloablative Cord Blood Transplantation with or without Infusion of Off-the-Shelf Ex Vivo Expanded Cryopreserved Cord Blood Progenitor Cells in Patients with Hematologic Malignancies

NCT01287585

Liver Cancer

POLARIS2009-001: A Randomized, Double-Blind, Multicenter Phase III Study of ADI PEG 20 Plus Best Supportive Care (BSC) versus Placebo Plus BSC in Subjects with Advanced Hepatocellular Carcinoma (HCC) who Have Failed Prior Systemic Therapy

NCT01673867

Lung Cancer

An Open-Label Randomized Phase III Trial of BMS-936558 versus Docetaxel in Previously Treated or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) 

NCT01712217

Lung Cancer

A Study of HSP90 Inhibitor AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-Small Cell Lung Cancer (NSCLC) 

NCT01642004

Lung Cancer

An Open-Label Randomized Phase III Trial of BMS-936558 versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) 

NCT01758458

Merkel Cell Carcinoma

Study to Evaluate Cellular Adoptive Immunotherapy Using Polyclonal Autologous CD8+ Antigen-Specific T Cells for Metastatic Merkel Cell Carcinoma

NCT01660750

Multiple Myeloma

A Multicenter Phase Ib, Open-Label, Dose-Finding Pilot Study to Evaluate the Combination of Carfilzomib and Cyclo-phosphamide with Dexamethasone Prior to Autologous Stem Cell Transplant in Patients with Transplant Eligible Newly Diagnosed Multiple Myeloma 

NCT01360853

Pancreatic Cancer

A Phase II/III, Multicenter, Randomized, Controlled Study to Compare the Efficacy and Safety of Gemcitabine Alone vs. ON 01910.Na Combined with Gemcitabine in Patients with Previously Untreated Metastatic Pancreatic Cancer 

NCT01253642

Prostate Cancer

A Phase II Study of MAOA Inhibitor Plus Docetaxel in Patients Currently Receiving and Progressing on Docetaxel Therapy

NCT01576172

Prostate Cancer

A Randomized Gene Fusion Stratified Phase II Trial of Abiraterone with or without ABT-888 for Patients with Metastatic Castration-Resistant Prostate Cancer

NCT01703065

Prostate Cancer

A Pilot Study of the Effects of Cabozantinib (XL184) on Bone Turnover and Microenvironment in Men with Non-Metastatic and Metastatic Castration-Resistant Prostate Cancer

NCT01503229

Prostate Cancer

Open-Label Pharmacodynamic Study of Abiraterone in the Treatment of Metastatic, Castration-Resistant Prostate Cancer 

NCT01283373

Prostate Cancer

A Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP3086S in Patients with Metastatic, Castration- Resistant Prostate Cancer 

NCT01106352

Prostate Cancer

A Study of Alpharadin® with Docetaxel in Patients with Bone Metastasis from Castration-Resistant Prostate Cancer (CRPC)

NCT01667536

Prostate Cancer

A Phase II Assessment of the Diagnostic Accuracy of Tc-MIP-1404 Imaging in Men with High-Risk Prostate Cancer Scheduled for Radical Prostatectomy and Extended Pelvic Lymph Node Dissection Compared to Histopathology 

NCT01668784

Renal Cell Carcinoma

A Randomized, Open-Label, Phase 3 Study of BMS-936558 vs. Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma who Have Received Prior Anti-Angiogenic Therapy

NCT01574716

Sarcoma

A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel in Metastatic Soft Tissue Sarcoma





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