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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Peritoneal Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: carboplatin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01248962

10-184

Details and patient eligibility

About

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.

Enrollment: 146 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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 Any such conditions that have occurred in the last 6 months but are no longer active at the time of registration are not considered exclusionary.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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Standard 30-minute infusion

Experimental group

Description:

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.

Treatment:

Drug: carboplatin

Drug: carboplatin

extended 3-hour infusion

Experimental group

Description:

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.

Treatment:

Drug: carboplatin

Drug: carboplatin