Overview

This trial is active, not recruiting.

Conditions ovarian cancer, fallopian tube cancer, peritoneal cancer
Treatments carboplatin
Phase phase 2
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator National Institutes of Health (NIH)
Start date November 2010
End date November 2017
Trial size 148 participants
Trial identifier NCT01248962, 10-184

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. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
carboplatin
Carboplatin Standard 30-minute infusion. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg (or famotidine 20mg IV)IV and diphenhydramine 50mg IV before carboplatin infusion.
(Experimental)
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 carboplatincontaining chemotherapy regimen.
carboplatin
Extended 3-hour infusion carboplatin. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg IV (or famotidine 20mg IV) and diphenhydramine 50mg IV before carboplatin infusion.

Primary Outcomes

Measure
To determine if patients have lower rates of hypersensitivity reactions compared to those treated with standard infusion carboplatin.
time frame: 2 years

Secondary Outcomes

Measure
Determine the rate of successful planned treatment completion of carboplatin in each group
time frame: 2 years
Perform a cost-identification analysis of extended infusion carboplatin to estimate the cost per hypersensitivity reaction prevented.
time frame: 2 years
Perform exploratory analyses to correlate hypersensitivity rate to history of atopy, prior drug allergies, number of lifetime platinum cycles, duration since last platinum, and concomitant chemotherapy agent.
time frame: 2

Eligibility Criteria

Female participants at least 21 years old.

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

Additional Information

Official title Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in theTreatment of Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer
Principal investigator Roisin O'Cearbhaill, MD BCh
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.
Location data was received from the National Cancer Institute and was last updated in October 2016.