Brief Title
Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in Patients With Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer
Official Title
Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in theTreatment of Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer
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 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants With and Without Hypersensitivity Reaction
Secondary Outcome
The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group
Condition
Ovarian Cancer
Intervention
carboplatin
Study Arms / Comparison Groups
Standard 30-minute infusion
Description: This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatin containing chemotherapy regimen.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
146
Start Date
November 2010
Completion Date
August 2018
Primary Completion Date
August 2018
Eligibility 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
Gender
Female
Ages
21 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Roisin O'Cearbhaill, MD BCh, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01248962
Organization ID
10-184
Responsible Party
Sponsor
Study Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Institutes of Health (NIH)
Study Sponsor
Roisin O'Cearbhaill, MD BCh, Principal Investigator, Memorial Sloan Kettering Cancer Center
Verification Date
June 2019