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

Phase 2

Completed

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.

Recruitment & 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 Any such conditions that have occurred in the last 6 months but are no longer active at the time of registration are not considered exclusionary.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

Arm && Interventions

Group	Intervention	Description
extended 3-hour infusion	carboplatin	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.
Standard 30-minute infusion	carboplatin	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With and Without Hypersensitivity Reaction	2 years	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

Secondary Outcome Measures

Name	Time	Method
The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate	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.
Perform a Cost-identification Analysis of Extended Infusion Carboplatin to Estimate the Cost Per Hypersensitivity Reaction Prevented.	2 years
The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group	2 years

Locations (1): Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States

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