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Clinical Trials Monthly - May 2011

Dear Colleague,

This month we’ve included newly opened Phase I, II and III trials as well as other selected ongoing trials for the following diseases: 

Each study summary has a link to the specific details about that trial in our online Clinical Trials Database. To see the complete list of trials open and recruiting at Seattle Cancer Care Alliance, go to www.seattlecca.org/clinicaltrials

Seattle Cancer Care Alliance also publishes a quarterly newsletter called The Leading Edge. If you’d like to receive a copy, please send an e-mail to contactus@seattlecca.org.

 

Breast Cancer

Zoledronic Acid for Bone Metastases from Breast Cancer (6979)
Zoledronic acid (Zometa) is an approved treatment for patients with bone metastasis and complications from multiple myeloma. This Phase III study looks at how effective zoledronic acid is in treating breast cancer patients with bone metastasis. The trial compares the effectiveness of giving zoledronic acid every four weeks versus every 12 weeks over the course of one year.

Patients are expected to be in this study for about one year. There will be a total of 15 scheduled patient visits to complete this study: a screening visit; 13 treatment visits once a month (treatment is IV infusion, usually for one hour) and one end-of-study visit. One arm will receive the drug every four weeks. The other arm will still come in every month, but will receive a placebo in between receiving the actual drug every 12 weeks. Patient diary information will be collected by a touch-tone telephone system once a week. There is an optional pharmacokinetic sub-study involving additional urine specimen collection. Treatment will be done at SCCA.

Investigator: Georgiana Ellis, MD

Lapatinib vs. Trastuzumab + Taxane for HER2/Positive First-line Metastatic Cancer (UW09024)
Drugs used in chemotherapy, such as paclitaxel (Taxol) and docetaxel (Taxotere), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab (Herceptin), can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them, or carry tumor-killing substances to them. It is not yet known whether chemotherapy is more effective with lapatinib or trastu-zumab plus Taxane in treating breast cancer patients. This randomized Phase III trial compares chemotherapy and lapatinib with chemotherapy and trastuzumab in treating women with HER2/neu-positive metastatic breast cancer. Treatment can occur at SCCA and the SCCA Network sites.

Investigator: Georgiana Ellis, MD

Comprehensive Patient Reported Outcomes (PRO) Management for Oncology Practice (6916)
This study examines the effectiveness of a newly developed computer system, designed to help patients report and manage symptoms related to chemotherapy and/or endocrine therapy. The system also notifies care providers of symptoms, allowing them to address them in a timely fashion. This study examines whether the reporting and notification features improve patient-provider communication and assist physicians in making clinical decisions. This study will take place for breast cancer patients only at SCCA and Arizona Cancer Center.

Investigator: V.K. Gadi, MD, PhD

Expanded Access of Iniparib in Combination for Triple Negative Metastatic
Breast Cancer (20100374) (10009)

Expanded access is for patients who would benefit from a life-saving drug but do not meet the full eligibility criteria for the clinical study of that drug. This trial offers pre-approval drug access to iniparib (a PARP inhibitor) with gemcitabine and carboplatin in order to provide potential clinical benefit to patients with ER-, PR- and HER2-negative metastatic breast cancer.

Eligible patients must have no prior treatment for metastatic disease or have received one to three prior chemotherapy treatments in the metastatic setting. Prior gemcitabine and/or platinum agents, however, are allowed. Patients must have metastatic breast cancer.

Investigator: Jennifer Specht, MD

Combined Targeted Therapies for Triple Negative Metastatic Breast Cancer (6628)
Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab (Avastin), can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread, while others find tumor cells and help kill them, or carry tumor-killing substances to them. Erlotinib (Tarceva) may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel albumin-stabilized nanoparticle formulation together with bevacizumab and erlotinib may kill more tumor cells. This Phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab work when followed by bevacizumab and erlotinib in treating patients with metastatic breast cancer.

Investigator: Jennifer Specht, MD

Sunitinib for Locally Advanced or Inflammatory Breast Cancer (6488)
The purpose of this Phase II study is to determine the safety and effectiveness of adding an investigational drug called sunitinib (Sutent) to the current standard drug treatment for patients with locally advanced or inflammatory breast cancer. The study evaluates the safety and efficacy of Sutent in combination with weekly paclitaxel, followed by doxorubicin and daily oral cyclophosphamide plus G-CSF as neoadjuvant chemotherapy. Participants will receive treatment at SCCA for about six months. If participants require hospitalization while in Seattle, they will be admitted to UWMC. Surgery, which is not a part of this study treatment, is expected to take place about a month after completion of this study treatment. Follow-up may continue for up to five years after treatment has stopped.

Investigator: Jennifer Specht, MD


Lung Cancer

Crizotinib vs. Standard Chemotherapy for ALK-Positive Non-Squamous Cell Lung Cancer (NCT01154140)
This is a first-line trial that will test the efficacy of Crizotinib versus standard chemotherapy (pemetrexed plus cisplatin or carboplatin) in patients with Stage IIIB/V ALK-positive non-squamous cell lung cancer. Patients will be randomized to either Crizotinib (oral pill) or standard intravenous chemotherapy. If a patient gets randomized to the standard chemo arm, upon disease progression the patient will cross over to Crizotinib. Archived or fresh tissue is required. Patients will need to come to SCCA every 21 days for all procedures.

Investigator: Keith Eaton, MD, PhD

Erlotinib (Tarceva ®) in Combination with OSI-906 for Non-small Cell Lung Carcinoma (NCT01221077)
This study will include patients who have Stage IIIB/V non-small lung cancer with activating mutations of the epidermal growth factor receptor (EGFR) gene, plus Exon 19 deletion or Exon 21 deletion and not have received any prior cancer therapy. Patients will be randomized to either Tarceva plus OSI-906 or Tarceva plus placebo; all are oral pills. Archived or fresh tissue will be required. All procedures must be done at SCCA; patients must come to SCCA every 21 days for treatment.

Investigator: Keith Eaton, MD, PhD


Lymphoma

DCDS4501A for Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia (FH2501)
There are no effective standard therapies for relapsed or refractory B-cell non-Hodgkin’s lymphoma or chronic lymphocytic leukemia. This Phase I study tests the safety and pharmacokinetics of a new drug/antibody conjugate developed by Genentech. Treatment will be administered with IV infusion every 21 days, on an outpatient basis at SCCA. The first infusion takes 90 minutes, with a 90-minute observation. Subsequent infusions will take 30 minutes, followed by a 30-minute observation (provided the first infusion is well tolerated). There will be several additional visits for labs and follow up. A total of eight treatments will be given initially, after which patients who respond to treatment may qualify to receive an additional six months of treatment. There are some restrictions based on how recently patients have received other treatments.

Investigator: Oliver Press, MD, PhD

TREC for Relapsed or Refractory Lymphoid Malignancies (PSOC 2502/NCT01165112)
This is a Phase I trial of bendamustine (Treanda), rituxmab, etoposide and carboplatin (TREC) for patients with relapsed or refractory lymphoid malignancies. The purpose of this trial is to study the side effects and best dose of bendamustine hydro-chloride when given together with rituximab, etoposide and carboplatin. Patients will receive outpatient IV infusions on days one to three for two cycles every 21 days. This is a PSOC protocol so patients could be treated at a local clinic, if the clinic/oncologist is a registered PSOC member for this trial. After two cycles, patients are restaged for response (e.g. CT scans, labs, physical examination, bone marrow); though this is a Phase I trial, response is a secondary objective.

Investigator: Ajay Gopal, MD and Lihua Elizabeth Budde, MD, PhD

CAL-101 for Indolent B-Cell Non-Hodgkin's Lymphoma (UW 10055/NCT01282424)
This Phase II study assesses the efficacy and safety of CAL-101 (an oral Delta Isoform-Selective PI3 kinase inhibitor) in patients with indolent B-cell non-Hodgkin’s lymphoma refractory to rituximab and alkylating agents. The primary objective will be to assess the overall response rate. Patients must come to SCCA for all study-related assessments and drug dispensing. Treatment consists of one capsule given orally twice a day, with continuous dosing until progression, other withdrawal or approval of the drug. There are up to two dose reductions for possible drug toxicity.

Investigator: Ajay Gopal, MD

Bendamustine for Rituximab-Refractory, Indolent Non-Hodgkin’s Lymphoma (FH2388)
This is an open-label, multicenter, randomized Phase III study to investigate the efficacy and safety of bendamustine (Treanda) compared with bendamustine with RO5072759 (GA101) in patients with rituximab-refractory, indolent non-Hodgkin’s lymphoma. Patients will be treated with either bendamustine alone or bendamustine with GA101—a new antibody that has not yet been approved by the U.S. Food and Drug Administration. Treatments will be given by IV infusion at SCCA, two consecutive days per month for six months. Patients who receive GA101 can continue to receive GA101 for an additional six months if they show a response to the initial treatment. Patients who receive bendamustine alone will be followed without treatment. This is a sponsor-initiated study.

Investigator: Oliver Press, MD, PhD

Brentuximab Vedotin with CHOP for Anaplastic Large Cell Lymphoma (NCT01309789)
This is a Phase I study of Brentuximab Vedotin (SGN35-011) administered sequentially and concurrently with CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) as front-line therapy in patients with systemic anaplastic large cell lymphoma (ALCL). Patients must be at least 18 years of age with a confirmed ALCL diagnosis that is either ALK-positive (Stage 3-4) or ALK-negative (all stages). Patients will be treated with a maximum of 16 cycles of the study drug, along with other chemotherapy drugs, if applicable. They will be followed very closely with regular blood draws and clinic visits, drug infusions and periodic disease restaging exams and radiology scans.

Investigator: Andrei Shustov, MD


Metastatic Melanoma

R05185426 for Metastatic Melanoma (ML25597/NCT01248936)
This is an open-label, non-comparative, multicenter, expanded access study for patients who have received prior systemic therapy for metastatic melanoma and who have no other satisfactory treatment options. (Expanded access means manufacturers make investigational drugs available, under certain circumstances, to treat patients with serious disease who cannot participate in a controlled clinical trial). Patients need to be screened to see if their tumors have the BRAF V600E mutation. This is seen in about half of melanomas, though it is very unlikely in patients with primary mucosal or ocular melanomas.

Patients will come to SCCA every four weeks for treatment. Visits will include a blood draw and scan (CT or MRI of known areas of disease—normally chest, abdomen and pelvis, and sometimes neck, brain or extremities as well) every eight to 16 weeks, depending on how frequent their physician thinks these scans should be. Patients on this clinical trial can only receive treatment at SCCA (or another center where this study is open). This study is not being done at any of the SCCA Network sites.

Investigator: Kim Margolin, MD


Pancreas Cancer

New Combination Treatment for Pancreas Cancer (UW6511/ NCT00609336)
This is a Phase II study of induction chemotherapy, neoadjuvant chemoradiotherapy, surgical resection and adjuvant chemo-therapy for patients with locally advanced, resectable pancreatic adenocarcinoma. We are studying a combination of drugs, radiation therapy and surgery to treat people with pancreatic cancer to learn the effects (good or bad) of this combination. We will give up to 30 patients this combination and watch carefully for any side effects. All of the drugs and procedures in this study have been approved by the U.S. Food and Drug Administration to treat various kinds of cancer, but the combination is not specifically approved to treat pancreatic cancer. Before patients begin the study, exams, tests or procedures will be done for eligibility screening. Patients will be on the study for 33 to 45 weeks, during which time they will receive:

  • Induction chemotherapy: three cycles of chemotherapy (GTX: gemcitabine, docetaxel and capecitabine) each lasting 21 days
  • Chemo-radiotherapy: one cycle lasting 14 days(CapOxRT: capecitabine, oxaliplatin and radiation therapy)
  • Radiation therapy: days one to five and days eight to 13
  • Surgery
  • Adjuvant chemotherapy: four to 10 weeks after surgery (GemOx: gemcitabine and oxaliplatin (four two-week cycles)
  • Single agent gemcitabine (two 28-day cycles)

Investigator: Samuel H. Whiting, MD, PhD

Referral or Consultation

To discuss treatment options for your patients with a physician, please call our intake office at (206) 288-SCCA (7222) or (800) 804-8824. To read the full description of each trial and or enroll your patients online, please see www.seattlecca.org/clinical-trials.


Adult Bone Marrow Transplant News

The SCCA Adult Bone Marrow Transplant News is a publication presenting the latest information on bone marrow transplant research at SCCA, providing up-to-date information for all health care professionals caring for transplant patients.

Pediatric Bone Marrow Transplant News

Read about important outcomes research at the Hutchinson Center that may benefit your patients.

Clinical Trials Monthly

Each issue of Clinical Trials Monthly highlights several of the more than 200 clinical trials that are currently recruiting patients at SCCA.

The Leading Edge Newsletter

Each quarterly Leading Edge newsletter will highlight a new topic to give you the latest news on leading-edge therapies that SCCA physicians are offering.