Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Miami
Age
18–80
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
1\. Patients must have platinum-resistant disease relapsing within 6 months or less from the date of their last cycle of initial adjuvant chemotherapy recurrent adenocarcinoma from a primary ovarian, tubal, or peritoneal cancer following first-line chemotherapy for metastatic disease. There is no limit on prior number of chemotherapy regimens. Patients who have received prior systemic docetaxel and platinum-based chemotherapy are eligible
1.1 Patients must have ≥ 1cm measurable disease on imaging studies independent of patients having an optional surgical salvage procedure.
2\. Patients must have a life expectancy of at least 6 months.
3\. Patients must have Karnofsky performance status of ≥ 60 or Gynecology Oncology (GOG) performance status of ≤ 2 (see www.GOG.org website).
4\. Age 18 - 80 years old
5\. Patients must have an adequate bone marrow, renal, and hepatic function:
* 5.1 WBC: ≥ 3,000 /mcl
* 5.2 ANC: ≥ 1,500 /mcl
* 5.3 Platelets: ≥ 100,000 /mcl
* 5.4 Creatinine: \< 2.0 mg/dcl
* 5.5 Bilirubin: \< 1.5x institutional normal value
* 5.6 LDH, GGT, SGPT (ALT), SGOT (AST), and ALK Phos:\< 3x institutional normal value.
6\. Ability to understand and the willingness to sign a written informed consent document.
You may not be if
1\. Patients who have received prior radiotherapy to the chest, whole abdomen, or lower extremities above the knees.
2\. Patients who have received prior radiation therapy to the head, neck, or lower extremities below the knees if greater than 3 years prior to study entry.
3\. Evidence of extra-abdominal extension of disease (such as groin nodes, lung, supraclavicular nodes, and pleural fluid).
4\. Patients may not be receiving any other investigational agents within 4 weeks preceding the start of study treatment) or chemotherapy for at least 3 weeks preceding the start of study treatment.
5\. Patients who have been diagnosed with another prior malignant tumor within 3 years of study entry, excluding non-melanoma skin cancer and carcinoma in situ of the cervix.
6\. Patients with prior history of a severe hypersensitivity reaction to paclitaxel (polysorbate 80-Cremophor).
7\. Patients with current history of uncontrolled hypertension, angina pectoris, heart failure, cardiac dysrhythmias, pericardial disease, cardiomyopathy, or active infection.
8\. Presence of any medical condition that in the opinion of the investigator deems the patient unable to participate.
9\. Females of child-bearing potential. It is expected that ovarian cancer patients would have had a hysterectomy and/or oophorectomy as part of the original standard of care.
10\. Patients that are \< 18 yrs. of age or \> 80 yrs. of age.
Clareo Health | LDFWART With Docetaxel in Patients With Platinum-Resistant Recurrent Ovarian Carcinoma
