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Leveraging a Clinico-Genomic Database to Match Patients to a Trial of Triciribine and Carboplatin: Changing Paradigms in Ovarian Cancer Clinical Research


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

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Trial Information

Leveraging a Clinico-Genomic Database to Match Patients to a Trial of Triciribine and Carboplatin: Changing Paradigms in Ovarian Cancer Clinical Research


A portion of the patient's cancer tissue, previously removed, will be analyzed for a
specific protein (phosphorylated BCL-2 antagonist of cell death). If the patient is found
to have high levels of this protein in their tumor, they may qualify to be in the study.


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

- 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: AST (SGOT) and ALT (SGPT) ≤ 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 patient 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

- Patient tumors must demonstrate high (>median) phospho-BAD levels on
immunohistochemical-based analyses.

Exclusion Criteria:

- Prior TCN-PM therapy

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to TCN-PM

- Patients must be disease-free of prior invasive malignancies for >2 years with the
exception of basal cell or squamous cell carcinoma of the skin.

- Inability to give informed consent

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Description:

To determine the maximum tolerated dose of TCN-PM when combined with carboplatin in a Phase I clinical trial of biomarker-selected women with platinum-resistant, recurrent or persistent epithelial ovarian, fallopian tube and primary peritoneal cancer (OVCA).

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Patricia L. Judson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC-17035

NCT ID:

NCT01690468

Start Date:

October 2013

Completion Date:

October 2015

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612