Status:
COMPLETED
Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in Patients With Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
21+ years
Phase:
PHASE2
Brief Summary
Patients who have this kind of cancer are often treated with several drugs. Carboplatin is one that seems to work for many treatment cycles. Even though it may work against the cancer, the patient can...
Eligibility Criteria
Inclusion
- MSKCC Histologically confirmed ovarian, fallopian tube or primary peritoneal carcinoma.
- Patient has received at least one prior platinum-containing (cisplatin or carboplatin) regimen
- Age ≥ 21 years old
- Karnofsky Performance Status (KPS) \> or = to 70%
- Adequate hematologic, hepatic and renal function as defined below:
- Hemoglobin ≥ 7.0 g/dl
- Absolute neutrophil count ≥ 1,000/mm3
- Platelet count ≥ 100,000/mm3
- Serum creatinine ≤ 1.5 x the upper limit of normal or calculated creatinine clearance ≥ 60 mL/min
Exclusion
- Prior carboplatin or cisplatin hypersensitivity reaction
- Uncontrolled intercurrent illness including infection, congestive heart failure, myocardial infarction, transient ischemic attack or stroke within 6 months. Any such conditions that have occurred in the last 6 months but are no longer active at the time of registration are not considered exclusionary.
- Patients receiving other investigational agents
- Patients with HIV disease will be permitted, only if they are on effective antiretroviral therapy, have a CD4 count greater than 400, and have had no opportunistic infections within the past 6 months
- Pregnant or lactating women
- Life expectancy of less than 12 weeks
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT01248962
Start Date
November 1 2010
End Date
August 1 2018
Last Update
October 2 2019
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065