Clinical Trials Monthly - November 2012
THIS MONTH'S FEATURED CLINICAL STUDIES
- Breast Cancer: Phase II assessment of pertuzumab with trastuzumab and vinorelbine
- Lung Cancer: BMS-936558 versus docetaxel for advanced NSCLC (UW12017)
- Melanoma: Trial of pIL-12 electroporation malignant melanoma (IL12MEL)
- Renal Cell Carcinoma: PF-04856884 + Axitinib for previously treated metastatic renal cell carcinoma
A Two-Cohort, Open-Label, Multi-Center Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination with Trastuzumab and Vinorelbine in First-Line Patients with HER2-Positive Advanced (Metastatic or Locally Advanced) Breast Cancer, (VELVET) UW12012, NCT01565083
In this multicenter Phase II trial, patients are enrolled into two cohorts:
- Cohort I: Pertuzumab and trastuzumab administered sequentially in separate infusion bags, followed by vinorelbine.
Cohort 2: Pertuzumab and trastuzumab administered together in
a single infusion bag followed by vinorelbine.
Inclusion criteria include patients with histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection may participate in this trial; HER2-positive (defined as either immunohistochemistry [IHC] 3+ or in situ hybridization [ISH] positive) as assessed by local laboratory on primary or metastatic tumor (ISH positivity is defined as a ratio of 2.0 or greater for the number of HER2 gene copies to the number of signals for CEPI7, or for single probe tests, a HER2 gene count greater than 4); at least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.; and an Eastern Cooperative Oncology Group (ECOG) performance status 0 or I.
Investigator: Jennifer Specht, MD
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) UW12017, NCT01642004
The purpose of the study is to compare the change in tumor size, and overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy. Criteria for eligibility in this study includes histologically or cytologic ally-documented squamous cell NSCLC who present with stage IIIB/IV disease or recurrent disease following radiation therapy or surgical resection; disease recurrence or progression during/after one prior platinum-containing chemotherapy regimen for advanced or metastatic disease; measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; and Eastern Cooperative Oncology Group (ECOG) performance status 1.
Investigator: Laura Q.M. Chow, MD
A Multicenter Phase II Trial of Intratumoral pIL-12 Electroporation in Advanced Stage Cutaneous and In-Transit Malignant Melanoma, NCT01502293
This is a single-arm, open-label, multicenter Phase II interventional trial for patients with AJCC stage IIIB, IIIC, or IV M1a melanoma with cutaneous or in-transit lesions accessible to electroporation. The goal of this study is to determine the 24-week distant response rate (complete and partial) of patients with advanced cutaneous melanoma treated with IL-12 plasmid electroporation. Treatment on this trial includes one eight-day cycle of IL-12 plasmid, 0.5 mg/ml X 1ml intratumorally with electroporation on days 1, 5, and 8. If there is evidence of persistent disease after 180 days (six months) and no evidence of systemic progression, patients may be retreated every three months at the investigator’s discretion. Otherwise, only one cycle of treatment will be given. Patient eligibility includes pathologically documented melanoma, AJCC stage IIIB, IIIC or IV M1a with cutaneous melanoma lesions accessible to electroporation. Patients with stage IIIB or IIIC disease may have cutaneous in-transit disease or cutaneous satellitosis and patients with stage IV M1a disease may have either of these with distant cutaneous metastatic sites; ECOG performance status 0-2; patients may have received prior chemotherapy or immunotherapy (with vaccines or Interferon or IL-2) for progression or persistent disease. All chemotherapy or immunotherapy must be stopped four weeks prior to electroporation. Patients may have had radiation therapy, but must have progressive disease after radiation therapy if the lesions to be electroporated are within the radiation field. In addition, it must be at least two weeks since administration of radiation therapy and all signs of toxicity must have abated.
Investigator: Shailender Bhatia, MD
A Phase II Trial of PF-04856884 (CVX-060), a Selective Angiopoietin-2 (Ang-2) Inhibitor in Combination with Axitinib in Patients with Previously Treated Metastatic Renal Cell Carcinoma, NCT01441414
In this study we will evaluate the combination of PF-04856884 (CVX-060) in combination with axitinib in patients who have received one prior systemic regimen for metastatic renal cell carcinoma (mRCC) versus axitinib alone. Eligibile patients will have histologically or cytologically confirmed renal cell cancer (RCC) with a component of clear cell subtype and evidence of metastasis; evidence of unidimensionally measurable disease; prior therapy (Part I) either having received one to three prior systemic regimens for treatment of mRCC, or (Part II) evidence of disease progression following one prior regimen administered as first-line therapy for mRCC. The prior regimen must have contained one of the following: VEGFR2 tyrosine kinase inhibitor (TKI) or other anti VEGF (Vascular Endothelial Growth Factor) compounds, such as bevacizumab; patients must have adequate bone marrow, liver, and renal function.
Investigator: Scott Tykodi, MD, PhD
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