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Clinical Trials Monthly - May 2012

 

Clinical Trials Monthly presents new and important trials that may benefit your patients. This month we’ve included trials for lung cancer, melanoma, and prostate cancer.

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

Non-Small Cell Lung Cancer

  • Onartuzumab (MetMAb) for squamous non-small cell lung cancer (NCT01519804)
  • Onartuzumab (MetMAb) + chemotherapy for nonsquamous non-small cell lung cancer (NCT01496742)
  • Erlotinib plus OSI-906 for non-small cell lung cancer (NCT01221077)

Melanoma

  • Combined BRAF inhibitor, dabrafenib, and MEK inhibitor, trametinib, compared to the BRAF inhibitor vemurafenib alone for stage IIIc or stage IV BRAF V600E/K mutationpositive cutaneous melanoma

Prostate Cancer

  • Sipuleucel-T and ADT for non-metastatic prostate cancer (NCT01431391)

Non-Small Cell Lung Cancer

A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (MetMAb) in Combination with Gemcitabine + Cisplatin or Carboplatin as First-line Treatment for Patients with Stage IIIb or IV Squamous Non-Small Cell Lung Cancer (NCT01519804)

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb or RO5490258) in combination with paclitaxel plus platinum in patients with stage IIIB or stage IV squamous non-small cell lung cancer. Onartuzumab is a humanized monovalent (one-armed) monoclonal antibody directed against the hepatocyte growth factor receptor (c-Met). A variety of cancer cells overexpress cMET; onartuzumab, by inhibiting the c-MET signaling pathway, may have antineoplastic activity.

Patients will be randomized to receive either onartuzumab 15 mg/kg IV or placebo on day one of each of four 21-day cycles in combination with paclitaxel 200 mg/m2 IV and platinum (carboplatin/cisplatin) standard dose IV on the same day. Patients who have not progressed after four cycles will continue with either onartuzumab or
placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.

Investigator: Keith D. Eaton, MD, PhD 

A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of RO5490258 (MetMAb) vs. Placebo in Combination with Either Bevacizumab + Platinum + Paclitaxel or Pemetrexed + Platinum in Patients with Untreated Stage IIIb or IV Non-Squamous Non- Small Cell Lung Cancer (NCT01496742) 

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb or RO5490258), a humanized monovalent (one-armed) monoclonal antibody directed against the hepatocyte growth factor receptor (c-Met), in combination with either of two backbone chemotherapy regimens in the first-line setting in patients with stage IIIB or IV non-squamous non-small cell lung cancer.

In Cohort One, patients will be randomized to receive four cycles of bevacizumab (Avastinâ) 15 mg/kg IV, paclitaxel 200 mg/m2 IV, platinum (cisplatin/carboplatin) standard dose IV plus either MetMAb 15 mg/kg IV or placebo on day one of each 21-day cycle.

In Cohort Two, patients will be randomized to receive pemetrexed 500 mg/m2 IV, platinum (cisplatin/carboplatin) standard dose IV plus either MetMAb 15 mg/m2 IV or placebo on day one of each 21-day cycle.

Patients who have not progressed after four cycles will be offered maintenance therapy with their assigned treatment. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Investigator: Keith D. Eaton, MD, PhD 

A Randomized, Double-Blind, Phase II Study of Erlotinib (Tarceva®) in Combination with OSI-906 or Placebo in Chemo-naive Patients with Advanced NSCLC with Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene (NCT01221077)

Erlotinib is an inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase. It works by blocking the action of an abnormal protein that signals cancer cells to multiply and thereby helps slow or stop the spread of cancer cells. In this trial erlotinib is being combined with a placebo or with OSI-906, which is a potential first-in-class small molecule, dual kinase inhibitor. Both active agents are administered orally, erlotinib at 150 mg once daily and OSI-906 at 150 mg twice daily.

OSI-906 helps to block a cellular pathway of resistance that sometimes develops in patients taking erlotinib. That’s why researchers are testing the potential clinical benefits of combining these two drugs. The specific kinase pathways blocked by OSI-906 involve the insulin-like growth factor-1 receptor (IGF-R1) and the insulin receptor (IR).

Investigator: Keith D. Eaton, MD, PhD 

Melanoma

A Phase III, Randomized, Open-Label Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to the BRAF Inhibitor Vemurafenib in Subjects with Unresectable (Stage IIIc) or Metastatic (Stage IV) BRAF V600E/K Mutation-Positive Cutaneous Melanoma www.seattlecca.org/clinical-trials/melanoma-list.cfm

The purpose of this study is to compare overall survival of patients with metastatic melanoma randomized to receive either dabrafenib (a BRAF inhibitor) and trametinib (a MEK inhibitor) to those randomized to receive vemurafenib (the FDA-approved BRAF inhibitor) alone.

Eligible patients must have unresectable stage III or stage IV melanoma, determined to be BRAF V600E or K-positive (by an assay done as part of the study). Patients may not have received prior systemic therapy for unresectable stage III or stage IV melanoma (prior systemic adjuvant therapy is allowed). A history or evidence of certain cardiac risk or brain metastases may be cause for exclusion. Patients are assigned randomly to receive oral doses of either 150mg BID of dabrafenib and 2.0mg QD of trametinib or 960mg BID of vemurafenib.

Patients will come to the clinic once every four weeks to be evaluated by the study doctor, return unused drug, and receive a new supply of study drugs. Patients will also have periodic ECGs, echocardiograms, and CT/MRI scans to evaluate safety and efficacy of the treatments. This study is still in the start-up phase and is not yet open to accrual at Seattle Cancer Care Alliance. Check the website for up-to-date information after June 1.

Investigator: Kim A. Margolin, MD 

Prostate Cancer

Sequencing of Sipuleucel-T and ADT in Men with Nonmetastatic Prostate Cancer (NCT01431391)

The main purpose of this study is to determine whether ADT (androgen deprivation therapy) started before or after sipuleucel-T (Provenge®) leads to a better immune system response. The trial will enroll men with nonmetastatic prostate cancer who have rising levels of prostate specific antigen (PSA) (doubling time £12 months). Half of the men will receive sipuleucel-T infusions first followed by leuprolide acetate (two depot injections, six months apart); the other half will receive ADT followed by sipuleucel-T.

The primary outcome will be immune response as measured by cytokine release following exposure to the fusion protein (PAP/GM-CSF) that is used to activate the immune cells in sipuleucel-T. This study will also evaluate the safety of sipuleucel-T treatment, immune system responses over time, sustained activation of antigen-presenting cells, and changes in PSA values over time.

Sipuleucel-T injection is an autologous cellular immunotherapy prepared from the cells of a patient's own blood. Sometimes referred to as a “cancer vaccine,” it works by causing the body's immune system to fight the cancer cells. It is currently approved for use only in men with asymptomatic metastatic prostate cancer who have already
failed ADT (ie, hormone-refractory prostate cancer).

Investigator: Evan Ya-Wen Yu, MD 

 

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. To read the full description of each trial or enroll your patients online, please visitwww.seattlecca.org/clinicaltrials.

 


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