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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: carboplatin


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 Any such conditions that have occurred in the last 6 months but are no longer active at the time of registration are not considered exclusionary.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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard 30-minute infusion<br>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. | Drug: carboplatin<br>* 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.<br>|
| Experimental: extended 3-hour infusion<br>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. | Drug: carboplatin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group |  | 2 years | 
| Perform a Cost-identification Analysis of Extended Infusion Carboplatin to Estimate the Cost Per Hypersensitivity Reaction Prevented. |  | 2 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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10-184, BEVACIZUMAB (AVASTIN), CARBOPLATIN, DEXAMETHASONE, GEMCITABINE, LIPODOX(LIPOSOMAL DOXORUBICIN), MONTELUKAST (SINGULAR), TAXOL (PACLITAXEL, Fallopian Tubes