Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in Patients With Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer
| Status: | Completed |
|---|---|
| Conditions: | Ovarian Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 8/11/2018 |
| Start Date: | November 2010 |
| End Date: | August 2018 |
Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in theTreatment of Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer
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 become allergic to it. If that happens, they would have to stop taking the
drug. The standard way to give carboplatin is by vein over 30 minutes. The purpose of this
study is to:
Find out if giving carboplatin over three hours can prevent the allergy. See if medicine
given before the carboplatin can help reduce the risk of allergic reactions.
Some patients have been given carboplatin over 3 hours instead of 30 minutes. They had fewer
allergies than we expected. We do not know if this was because of the way they got
carboplatin or because of something else.
one that seems to work for many treatment cycles. Even though it may work against the cancer,
the patient can become allergic to it. If that happens, they would have to stop taking the
drug. The standard way to give carboplatin is by vein over 30 minutes. The purpose of this
study is to:
Find out if giving carboplatin over three hours can prevent the allergy. See if medicine
given before the carboplatin can help reduce the risk of allergic reactions.
Some patients have been given carboplatin over 3 hours instead of 30 minutes. They had fewer
allergies than we expected. We do not know if this was because of the way they got
carboplatin or because of something else.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Roisin O'Cearbhaill, MD BCh
Phone: 646-888-4227
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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