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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01248962
• Other study ID #: 10-184
• Status: Completed
• Phase: Phase 2
• Start date: November 2010
• Est. completion date: August 2018

Study information

• Verified date: June 2019
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Cancer
• Peritoneal Neoplasms

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With and Without Hypersensitivity Reaction	The primary objective of this study is to determine if patients have lower rates of hypersensitivity reactions by comparing the number of participants with and without hypersensitivity reaction	2 years
Secondary	The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group		2 years
Secondary	Perform a Cost-identification Analysis of Extended Infusion Carboplatin to Estimate the Cost Per Hypersensitivity Reaction Prevented.		2 years
Secondary	The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate	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.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center