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Clinical Trial 18641

Cancer Type: Gynecological Tumor
Interventions:PTX-200; Paraplatin (carboplatin); Triciribine Phosphate monohydrate (PTX-200); carboplatin

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Robert Wenham

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase IA/IB Trial of PTX-200 and Carboplatin in Patients with Platinum-Resistant Recurrent Ovarian Cancer

Summary

The main purpose of this study is to determine if Triciribine (TCN) and carboplatin are safe and tolerable when given together, and to determine if this combination of drugs can help people with recurrent ovarian cancer.

Objective

Primary Objective: To determine the maximum tolerated dose of PTX-200 when combined with carboplatin in a Phase IA clinical trial of women with platinum-resistant, recurrent or persistent OVCA. Secondary Objectives: a) To evaluate the clinical activity of carboplatin plus PTX-200 in women with recurrent/persistent, platinum-resistant OVCA in a phase IB clinical trial assessing response rate, progression-free survival, and duration of stable disease. b) To assess the effect of PTX-200 on phospho-Akt signaling, proliferation and apoptosis within circulating tumor cells. c) Correlative studies to determine baseline p-Akt expression and signaling within circulating tumor cells and the ability of PTX-200 to downregulate p-Akt signaling, inhibit proliferation, and induce apoptosis.

Inclusion Criteria

  • At least 18 years of age
  • Histologically confirmed, measurable or non-measurable, recurrent or persistent, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma. By standard Gynecologic Oncology Group (GOG) criteria, platinum-resistant disease is defined by a disease-free interval of less than 6 months following treatment with a platinum-based regimen, or the progression of disease during platinum-based therapy.
  • At least one prior regimen of chemotherapy, with no maximum number of chemotherapy cycles
  • A serum creatinine ≤ 1.5 mg% obtained ≤ 2 weeks prior to entry
  • Adequate hematologic reserve obtained ≤ 2 weeks prior to entry: leukocytes ≥ 3,000 mm^3; absolute neutrophil count ≥ 1500 mm^3; platelets ≥ 100,000 mm^3
  • Adequate hepatocellular function: aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 3x upper limit of normal within institutional limits; bilirubin ≤ 1.5 mg/dl
  • Gynecologic Oncology Group (GOG) Performance Status of 0, 1, or 2
  • Life expectancy of at least 90 days
  • The participant should be off chemotherapy, biologic therapy and radiation for 28 days.
  • Neuropathy (sensory and motor) less than or equal to grade 1 per Common Toxicity Criteria (CTC) version 4

  • Exclusion Criteria

  • Prior PTX-200 therapy
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to PTX-200.
  • Prior invasive malignancies less than 2 years with the exception of basal cell or squamous cell carcinoma of the skin.
  • Inability to give informed consent
  • Pregnancy
  • Uncontrolled intercurrent illness
  • An absolute medical requirement to be chronically on a drug known to prolong the QT interval. Patient may be on drug known to prolong the QT interval, but this should be a medication that could be discontinued, or switched to an alternative, should a new abnormality in QT interval be observed.
  • HIV-positive patients receiving combination anti-retroviral therapy
  • Chronic interstitial or inflammatory lung disease
  • Receiving other investigational agent(s)