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|NCT02569957 : Effect of Acetylcysteine With Topotecan Hydrochloride on the Tumor Microenvironment in Patients With Persistent or Recurrent High Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer|
|Ages||Min: 18 Years Max: N/A|
1. Patient must have persistent or recurrent high grade endometrioid or serous ovarian,
primary peritoneal or fallopian tube carcinoma. Histologic documentation of the
original primary tumor is required via the pathology report.
2. All patients must have measurable disease that is amenable to biopsy. Measurable
disease is defined as at least one lesion that can be accurately measured in at least
one dimension (longest dimension to be recorded). Each lesion must be ?20 mm when
measured by conventional techniques including palpation, plain film x-ray, CT, and
MRI, or ? 10 mm when measured by high resolution CT.
3. Patient must have at least one target lesion to be used to assess response on this
protocol as defined by RECIST 1.1. Tumors within a previously irradiated field will
be designated as non-target lesions unless progression is documented or a biopsy is
obtained to confirm persistent disease at least 90 days following completion of
4. Patients must have a GOG performance status of 0, 1, or 2.
5. Patients must be free of active infections requiring antibiotics, with the exception
of uncomplicated urinary tract infections (UTIs).
6. Any hormonal therapy directed at the tumor must be discontinued at least one week
prior to initiation of therapy. Continuation of hormone replacement therapies is
7. Any other prior therapy directed at the tumor, including immunologic agents, must be
discontinued at least 3 weeks prior to initiation of therapy.
8. Patients must have had at least one prior platinum/taxane combination
chemotherapeutic regimen for management of primary disease containing carboplatin,
cisplatin, or another organoplatin compound. This initial treatment may include
intraperitoneal therapy, high dose therapy, consolidation, noncytotoxic agents, or
9. Patients must be platinum resistant- defined as progressive disease while receiving
platinum therapy or within 6 months of completing first line platinum therapy or
patients who have progressive disease after two lines of platinum based treatment.
1. Cytotoxic regimens are any that include agents that target the genetic and/or
mitotic apparatus of the dividing cells, resulting in dose limiting toxicity to
the bone marrow or gastrointestinal mucosa
2. Patients are allowed to receive, but not required to receive biologic
(noncytotoxic) therapy as part of their treatment regimen, e.g. bevacizumab.
10. Patients Must Have Adequate:
1. Bone Marrow Function: Absolute Neutrophil Count greater than or equal to
1000/mcl. Platelets greater than or equal to 100,000/mcl. Hemoglobin greater
than 10 g/dl. (Patients may be transfused to achieve this hemoglobin.)
2. Renal Function: creatinine less than or equal to 1.5 x upper limit of normal,
CTCAE v 4.0 grade 1.
3. Hepatic Function: bilirubin less than or equal to 1.5 x upper limit of normal,
CTCAE v 4.0 grade 1. Asparate transaminase (AST) and alkaline phosphatase less
than or equal to 2.5 x upper limit of normal, CTCAE v 4.0 grade 1.
4. Coagulation: PT, PTT less than or equal to 1 to 1.5 x upper limit of normal
CTCAE v 4.0 grade 1 except for patients on therapeutic anticoagulation.
5. Neurologic Function: neuropathy (sensory and motor) less than or equal to CTCAE
v 4.0 grade 1.
11. Patients must have signed an approved informed consent and authorization permitting
release of personal health information.
12. Patients must meet pre-entry requirements as specified.
13. In the unlikely event that patients are still of childbearing potential, these
patients must have a negative serum pregnancy test within 72 hours prior to
initiating protocol therapy and be practicing an effective form of contraception
during protocol therapy and for at least 4 weeks following completion of protocol
14. Patients must be 18 years of age or older.
15. Patients must not be receiving any other investigational agent.
16. Patients must be able to swallow whole pills. -
1. Patients who have had previous treatment with topotecan.
2. Patients who have had more than 4 prior chemotherapy regimens.
3. Patients who have received radiation to more than 25% of marrow-bearing areas.
4. Patients with a history of other invasive malignancies are excluded if there is any
evidence of other malignancy being present within the last 3 years.
5. Patients who have received prior chemotherapy for any abdominal or pelvic tumor other
than for treatment of ovarian carcinoma within the last 3 years are excluded.
Patients may have received prior chemotherapy for localized breast cancer, provided
that it was completed more than three years prior to registration and the patient
remains free of recurrent of metastatic disease.
6. Pregnant or nursing women or women of childbearing potential unless using effective
contraception as determined by the investigator. -
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