Phase I Group

Four investigators from the Department of Medicine comprise the core of the RPCI Phase I Program, together with 4 clinical research coordinators, a regulatory research associate, two investigational drug pharmacists, a PK/PD expert, a laboratory based pharmacogeneticist, a pathologist, biostatistician and radiologist. This group is directed by Dr. Alex Adjei and meets weekly to review studies and patients on studies. In addition to this core group, other clinical investigators perform disease oriented phase I studies (ovarian cancer, colorectal cancer, prostate cancer and gastric cancer as examples) and interact with the phase I group regularly. Approximately 170 patients are enrolled on phase I trials annually. Unique features of this program are:

A dedicated clinical research center: This center has a central nursing area, 17 rooms, 10 of which are private, for administration of chemotherapy. In addition, the Unit also has a procedure room and real-time processing laboratory for performing pharmacokinetic, pharmacodynamic, and correlative science and target validation assessments, as well as storage for patient samples. Telemetry is available for cardiac and other intensive monitoring. The CRC provides a full range of services specializing in early studies involving complex procedures, which are traditionally difficult to perform on the general oncology in-patient unit. These include intense sampling for pharmacokinetic and pharmacodynamic assessments, cardiac monitoring including multiple EKGs, echocardiograms, QTc measurements.

A translational oncology laboratory: This lab develops and performs correlative laboratory studies in conjunction with clinical trials in collaboration with investigators. The lab routinely will:

  • Acquire all nonstandard reagents (e.g., noncommercial antibodies),
  • Develop a protocol that has been optimized for research purposes,
  • Establish a standard operating procedure for correlative assays,
  • Assess reproducibility of the proposed method and establish suitable intra- and inter- assay controls,
  • Acquire, store and assay all samples from clinical studies,
  • Analyze the results with appropriate statistical input,
  • Provide publication-quality examples of the results
  • Perform SNP identification, genotyping, haplotype analysis and genotype-phenotype correlations
  • Preclinical drug testing in primary human tumors grown as xenografts in SCID mice
  • Pharmacogenetic Analysis
  • PK/PD Modeling

There are currently 10 phase I trials accruing patients with others in development, evaluating drugs targeting, which include the following:

  • The IGF-1 receptor
  • Src kinases
  • Aurora kinases
  • c-MET
  • HSP90
  • MEK
  • Several Angiogenesis signaling proteins
  • EGFR family inhibitors