Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT01690468
Eligibility Criteria:
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 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
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
* Pregnancy
* Corrected QT interval (QTc) prolongation \> 450 milliseconds (msec)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01690468
Study Brief:
Protocol Section:
NCT01690468