Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Alabama at Birmingham
With
National Cancer Institute (NCI)
Age
19–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Patients must have histologically documented invasive epithelial ovarian or extra-ovarian adenocarcinoma
Patients must have persistent or recurrent disease after standard debulking/staging surgery and conventional chemotherapy.Prior chemotherapy must have included a taxane/platinum based regimen
Patients must have evidence of intraabdominal disease; disease may be measurable or nonmeasurable
Patients must have a GOG performance status of 0, 1, or 2, and have a life expectancy of greater than 3 months
Patients must have adequate hematologic, renal, cardiac, pulmonary, coagulation, and hepatic function defined as:
1. WBC\> 3,000 ul
2. Granulocytes\> 1,500 ul
3. Platelets\> 100,000
4. Creatinine clearance (actual or calculated) \>80 mg/dl or serum creatinine \<2.0
5. Serum transaminases \<2.5x upper limits of normal
6. Normal serum bilirubin
7. PT/PTT/INR \< 1.5 x institutional ULN
8. Ejection fraction on echocardiogram \> 55%
9. O2 saturation \> 92%
Patients must be 19 years or older (as mandated by Alabama state law) and must have signed informed consent
You may not be if
Patients with epithelial ovarian tumors of low malignant potential (with or without invasive implants), with ovarian stromal tumors, or with germ cell tumors of the ovary are ineligible to participate in the study
Patients with the only site of disease located beyond the abdominal cavity are ineligible to participate in the study
Patients who are pregnant or lactating are ineligible to participate in the study
Patients with a GOG performance status of 3 or 4 are ineligible to participate in the study
Patients with active heart disease (characterized by angina, unstable arrhythmia, congestive heart failure or EF \< 55%, pulmonary hypertension), active or chronic debilitating pulmonary disease (i.e., active pneumonia, severe COPD, pulmonary edema, O2 saturation \< 92%), or coagulation disorders (i.e., bleeding disorders, on therapeutic anti-coagulants)
Clareo Health | Safety Study of a Genetically Modified Adenovirus in Ovarian Cancer Patients
