Clinical trial NCT01248962: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Keywords: BEVACIZUMAB (AVASTIN)
CARBOPLATIN
DEXAMETHASONE
GEMCITABINE
LIPODOX(LIPOSOMAL DOXORUBICIN)
MONTELUKAST (SINGULAR)
TAXOL (PACLITAXEL
Fallopian Tubes
10-184
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2010-11-25
Enrollment: 146
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With and Without Hypersensitivity Reaction
timeFrame: 2 years
Secondary outcomes:
measure: The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group
timeFrame: 2 years
measure: Perform a Cost-identification Analysis of Extended Infusion Carboplatin to Estimate the Cost Per Hypersensitivity Reaction Prevented.
timeFrame: 2 years
measure: The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Roisin O'Cearbhaill, MD BCh
role: PRINCIPAL_INVESTIGATOR
References: