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 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT01715168
Eligibility Criteria:
Inclusion Criteria:
1. Have histologically confirmed ovarian cancer that is potentially sensitive to DOXIL/CAELYX
2. Have disease progression or recurrence after a maximum of 2 prior chemotherapies, one of which was platinum based.
3. Be DOXIL/CAELYX treatment naïve
4. Have a normal left ventricular ejection fraction (LVEF) based on institutional ranges.
5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of \</= 2
6. Have an estimated life expectancy of ≥ 3 months
7. Be \>/= 18 and \</= 70 years of age
8. Sign a written Institutional Review Board (IRB)-approved informed consent form
9. Have a negative pregnancy test, if patient is of child-bearing potential
10. Have acceptable liver function:
* Bilirubin \</= upper limit of normal (ULN)
* AST (SGOT), ALT (SGPT) and Alkaline phosphatase \</= 1.5 times upper limit of normal
11. Have acceptable renal function:
* Serum creatinine within normal limits, OR calculated creatinine clearance \>/= 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
12. Have acceptable hematologic status:
* Neutrophils \>/= 1500 cells/mm3
* Platelet count \>/= 100,000 (plt/mm3)
* Hemoglobin \>/= 9 g/dL
13. Have acceptable coagulation status:
* Prothrombin time (PT) or International Normalized Ratio (INR) within 1.5 × ULN
* Partial thromboplastin time (PTT) within 1.5 × ULN
14. Agree to use effective contraceptive methods during the study (nonsterile patients of childbearing potential)
Exclusion Criteria:
1. Have New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG) or during Cardiac Stress Testing within 14 days prior to Day 1
2. Have received \> 250 mg/m2 of doxorubicin or equivalent as other anthracyclines or similar compounds
3. Have received prior treatment with DOXIL/CAELYX
4. Have received radiotherapy to the mediastinal area or concomitant therapy with other potentially cardiotoxic agents
5. Have seizure disorders requiring anticonvulsant therapy
6. Have known brain metastases (unless previously treated and well controlled for a period of \>/= 3 months)
7. Have severe chronic obstructive pulmonary disease with hypoxemia
8. Have had major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1
9. Have an active, uncontrolled bacterial, viral, fungal, or other opportunistic infections requiring systemic therapy
10. Are pregnant or nursing. NOTE: Nonsterile women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
11. Have received treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to study entry (6 weeks for nitrosoureas or Mitomycin C).
12. Have received radiation therapy to \>25% of her total bone marrow during her lifetime
13. Are unwilling or unable to comply with procedures required in this protocol
14. Have known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
15. Have a serious nonmalignant disease (e.g., hydronephrosis, liver failure, significantly impaired hepatic function, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
16. Are currently receiving any other investigational agent
17. Have exhibited allergic reactions to doxorubicin or a similar structural compound
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01715168
Study Brief:
Protocol Section:
NCT01715168