Status:
COMPLETED
Pharmacokinetic Study of Avastin and Doxil in Ovarian Cancer
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Genentech, Inc.
University of New Mexico Cancer Center
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
This study is to study pharmacokinetics of Doxil using Doxil and Avastin on ovarian cancer patients who are resistant to or have relapsed from platinum-based therapy.
Detailed Description
This study registration at clinicaltrials.gov is divided into 2 records. This record (NCT00846612) is for pharmacokinetics of Doxil. Another record (NCT00945139) describes the efficacy and safety of t...
Eligibility Criteria
Inclusion
- Patients must be platinum resistant
- No prior anthracycline use
- PS ≤ 2
- Lab values within certain limits (ANC \> 1000, platelets \> 100,000; ALT, AST 2x ULN, creatinine \< 2.0);
- No more than 3 prior chemotherapy regimens, only 2 of which can have included platinum-containing regimens.
- Use of effective means of contraception in subjects of child-bearing potential
Exclusion
- Disease-Specific Exclusions:
- Evidence of complete or partial bowel obstruction
- Need for IV hydration or TPN
- \> 2 prior abdominal surgeries
- History of gastrointestinal perforation
- Gastrointestinal perforation due to any other cause within the last 6 months
- General Medical Exclusions:
- Inability to comply with study and/or follow-up procedures
- Life expectancy of less than 12 weeks
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored Avastin cancer study
- Avastin-Specific Exclusions:
- Inadequately controlled hypertension (defined as systolic blood pressure greater than 150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications)
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E of the protocol)
- History of myocardial infarction or unstable angina within 6 months prior to study enrollment
- History of stroke or transient ischemic attack within 6 months prior to study enrollment
- Known CNS disease
- Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- Symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
- History of abdominal fistula, or intra-abdominal abscess within 6 months prior to study enrollment
- Serious, non-healing wound, ulcer, or bone fracture
- Proteinuria at screening as demonstrated by either
- Urine protein:creatinine (UPC) ratio no less than 1.0 at screening OR
- Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible).
- Known hypersensitivity to any component of Avastin
- Pregnant (positive pregnancy test) or lactating. No effective means of contraception (men and women) in subjects of child-bearing potential
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00846612
Start Date
January 1 2008
End Date
June 1 2012
Last Update
September 30 2019
Active Locations (4)
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1
Univ. of New Mexico cancer research and treatment center
Albuquerque, New Mexico, United States, 87131
2
Bellevue Hospital
New York, New York, United States, 10016
3
NYU Cancer Center
New York, New York, United States, 10016
4
NYU medical center (Tisch Hospital)
New York, New York, United States, 10016