Overview

Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in Patients With Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer

Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
0
Participant gender:
Female
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 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. Some people have been given carboplatin over 3 hours rather than 30 minutes and had fewer allergies than expected. 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Institutes of Health (NIH)
Treatments:
BB 1101
Carboplatin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Montelukast
Criteria
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conditions that have occurred in the last 6 months but are no longer active at the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