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Clinical Trials Monthly - December 2011

Dear Colleague,

Each month Clinical Trials Monthly presents new and important trials that may benefit your patients. Each study summary has a link to the specific details about the trial in our online Clinical Trials Database. The complete list of all trials recruiting participants at Seattle Cancer Care Alliance can be found at www.seattlecca.org/clinicaltrials.

THIS MONTH’S FEATURED CLINICAL STUDIES

Thyroid Cancer

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of E7080 in 131I-Refractory Differentiated Thyroid Cancer (NCT01321554)

This is a Phase III trial that may lead to Food & Drug Administration approval of lenvatinib (E7080) in well-differentiated thyroid cancer. After establishing efficacy and tolerability in a Phase II trial of this drug, SCCA physicians are excited to be able to offer continued access to this drug while it remains unavailable commercially.

Patients eligible for this research study have differentiated thyroid cancer that has not responded or has come back, worsened despite treatment with radioactive iodine, or for which there is no established effective treatment available. E7080 is designed to work by stopping the formation of new blood vessels that help tumors grow and spread. The main purpose of this study is to determine the effects (good and/or bad) of E7080 in patients with this type of thyroid cancer, to measure any tumor shrinkage, and to see how long any anti-tumor effects last. There have been six other studies testing E7080 in about 300 patients with different types of cancers including differentiated thyroid cancer. In this study, which is expected to last for 36 months, patients will take the study drug (24 mg E7080) or placebo orally once daily.

Investigator: Renato G. Martins, MD, MPH

Multiple Myeloma

A Single-Arm, Open-Label, Phase II Clinical Trial Evaluating Disease Response Following Treatment with Intravenous BHQ880, a Fully Human, Anti-Dickkopf1 (DKK1) Neutralizing Antibody, in Untreated Patients with High-Risk, Smoldering Multiple Myeloma (NCT01302886)

This will be the first study to determine the treatment effects of BHQ880 in patients with smoldering multiple myeloma.

BHQ880 is a monoclonal antibody therapy. One way BHQ880 works is by helping bone-forming cells regain their ability to make bone. Bone destruction and resulting bone pain is a symptom of multiple myeloma. BHQ880 has also been shown to affect the growth of multiple myeloma cells in laboratory studies. It is not known whether BHQ880 will affect the growth of multiple myeloma cells in patients.

Patients with “smoldering” myeloma are essentially asymptomatic: they are not significantly anemic, do not have high calcium or bone disease, and do not have kidney impairment. “High-risk” however means that, due to certain features, these patients are considered very likely to progress to symptomatic disease in a short time. In this trial, patients will receive BHQ880 via intravenous infusion (over two hours) every 28 days for 12 months. With visits for monthly infusions plus tests for safety, bone metabolism/density, and drug pharmacokinetics, patients will come to SCCA 21 times over about 14 months with a follow-up visit at 90 days after the final treatment.

Investigator: William Bensinger, MD

Bone Marrow Transplantation

A Phase III Randomized, Multicenter Trial Testing Whether Exercise and/or Stress Management Improves Functional Status And Symptoms of Autologous and Allogeneic Recipients (NCT01278927)

Earlier studies suggest that patients who exercise and/or use stress management methods after transplant may have better physical and mental well-being than patients who do not. In this study, we hope to confirm any such improvements in patient quality of life, including emotional and physical health, and to measure how long any such improvements may last. Although the study may not benefit participants directly, we believe that the information gained will help future transplant patients.

Patients in this study will be randomly assigned to one of four groups before their transplant date. Group 1 will get general information about transplantation and how to take care of themselves after their transplant. Group 2 will get information about exercise and be asked to exercise regularly after their transplant. Group 3 will get information about stress management and be asked to use stress management methods after their transplant. Group 4 will get information about both and be asked to exercise regularly and use stress management methods after their transplant.

Investigator: Stephanie Lee, MD, MPH

Hodgkin's and Non-Hodgkin's Lymphoma

Phase II Safety and Efficacy Study of Cal-101 (GS-1101) in Relapsed or Refractory Hodgkin’s Lymphoma (NCT01393106)

CAL-101 (GS-1101) is a potent, selective inhibitor of a type of phosphatidylinositol 3 kinase (PI3K) enzyme that is implicated in cancer and inflammatory diseases. In the Phase I trial of this drug, CAL-101 was well tolerated with no dose-limiting toxicity in any of the patients. CAL-101 decreases cellular proliferation and/or cell death in a range of NHL cell lines.

In this open-label single-arm Phase II study, patients with histologically confirmed classic Hodgkin’s lymphoma will receive CAL-101 in tablet form to be taken twice per day, once in the morning and once in the evening, starting at 150 mg twice per day. Treatment with CAL-101 can continue in responding patients as long as the study is still ongoing and the patients have no excess toxicity from treatment. The primary outcome is overall response rate.

Investigator: Ajay Gopal, MD

Phase II Study to Assess the Efficacy and Safety of Cal-101 in Indolent B-Cell Non-Hodgkin’s Lymphoma Refractory to Rituximab and Alkylating Agents (NCT01282424)

The purpose of this study is to evaluate the efficacy and safety of CAL-101 in patients with previously treated indolent (slow-growing) non-Hodgkin’s lymphoma (iNHL) that is resistant to rituximab and alkylating-agent chemotherapy. The primary objective will be to assess the overall response rate.

CAL-101 (GS-1101) is a potent, selective inhibitor of a type of phosphatidylinositol 3 kinase (PI3K) enzyme that is implicated in cancer and inflammatory diseases. In the Phase I trial of this drug, CAL-101 was well tolerated with no dose-limiting toxicity in any of the patients. CAL-101 decreases cellular proliferation and/or cell death in a range of NHL cell lines.

Eligible patients will be older than 18 years of age and have a histologically confirmed B-cell iNHL. They will receive CAL-101 in tablet form to be taken twice per day, once in the morning and once in the evening. Treatment with CAL-101 can continue in responding patients as long as the study is ongoing and the patients have no excess toxicity from treatment.

Investigator: Ajay Gopal, MD

Breast Cancer

MARIANNE Trial: A Randomized, Three-Arm, Multicenter, Phase III Study to Evaluate the Efficacy and The Safety of T-DM1 Combined with Pertuzumab or T-DM1 Combined with Pertuzumab-Placebo (Blinded For Pertuzumab), versus the Combination of Trastuzumab Plus Taxane, as the First Line Treatment of HER2 Positive Progressive, Recurrent Locally Advanced, or Metastatic Breast Cancer

T-DM1 is a conjugate of trastuzumab (Herceptin®), the much-used anti-HER2 breast cancer agent, and DM1, a maytansine derivative with potent cytotoxic and mitosis-blocking activity. It is hoped that conjugation will improve cell targeting and reduce toxicity of DMI. Pertuzumab is a newer monoclonal antibody that inhibits HER2 receptors from pairing with other HER receptors.

This is a study for patients with HER2-positive progressive or recurrent locally advanced or untreated metastatic breast cancer. Patients will be randomly assigned to one of the three treatment arms described above. We are looking for the response rate, survival rate, and one and two-year survival rates.

Investigator: Julie Gralow, MD

Combined Targeted Therapies for Triple Negative, Advanced  Breast Cancer – a Phase II Trial of Weekly Nab-Paclitaxel (Abraxane®) and Bevacizumab (Avastin®) Followed by Maintenance Targeted Therapy With Bevacizumab (Avastin) and Erlotinib (Tarceva®) (NCT00733408)

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, 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 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 studies how well paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab work when followed by bevacizumab and erlotinib in treating patients with metastatic breast cancer.

Enrolled patients receive the paclitaxel formulation IV once weekly for 24 weeks and bevacizumab IV once every two weeks for 24 weeks. Patients responding to this induction therapy receive bevacizumab IV once every two weeks plus oral erlotinib once daily.

Investigator: Jennifer Specht, MD

For more info: Phase II Study Evaluating the Safety and Efficacy of Sunitinib Maleate (Sutent®) in Combination with Weekly Paclitaxel (Taxol®) Followed by Doxorubicin (Adriamycin®) and Daily Oral Cyclophosphamide (Cytoxan®) Plus G-CSF as Neoadjuvant Chemotherapy for Locally Advanced or Inflammatory Breast Cancer (NCT00513695)

The purpose of this study is to determine the safety and effectiveness of an investigational drug treatment for patients with locally advanced or inflammatory breast cancer. The investigational drug called sunitinib inhibits cell signaling that is involved with tumor cell proliferation and angiogenesis. In this study, sunitinib will be added to the current standard (i.e., non-research) drug treatment regimen for locally advanced or inflammatory breast cancer.

Treatment in this study will last about six months. Surgery, which is not a part of this study, is expected to take place about a month after completion of this study treatment. Participants will receive treatment at Seattle Cancer Care Alliance. If hospitalization is needed while in Seattle, participants will be admitted to University of Washington Medical Center. Follow-up may continue for up to five years after treatment has stopped.

Investigator: Jennifer Specht, MD

A Prospective, Randomized, Double-Blind, Stratified, Multicenter, Two-Arm Trial of the Continued Efficacy and Safety of Zometa® (Every Four Weeks vs. Every 12 Weeks) in Patients with Documented Bone Metastases from Breast Cancer (NCT00320710)

This clinical study will look at the effectiveness of giving Zometa (zoledronic acid) every four weeks for one year versus every 12 weeks for one year in breast cancer patients with bone metastases that have been pretreated with Zometa.

Zometa is administered by injection to treat hypercalcemia of malignancy (HCM), a condition resulting in high calcium blood levels due to cancer. Zometa is also used to reduce and delay bone complications due to bone metastases from solid tumors. It is used with anti-cancer medicines and is not an anti-cancer therapy.

To determine efficacy, we will measure patients’ skeletal related event (SRE) rate during continued treatment in two dosing groups. SREs include bone fracture, radiation therapy/surgery to bone, and spinal cord compression. Patients in this study have documented bone metastases from breast cancer, and have been pretreated with Zometa or Aredia® (pamidronate), or all sequential regimens of both agents, for at least nine doses during the first 10 to 15 months of treatment, and are on either Zometa or Aredia at the time of study entry.

Investigator: Georgiana Ellis, MD

Refer your patients online!

You may refer your patients for treatment on a clinical trial online at www.seattlecca.org/clinicaltrials.

Referral or Consultation

To discuss your patients’ treatment options with an SCCA physician, please call our intake office at (206) 288-SCCA (7222) or (800) 804-8824. 


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