DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Intervention: carboplatin (Drug); carboplatin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Roisin O'Cearbhaill, MD BCh, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

Overall contact:
Roisin O'Cearbhaill, MDBCh, Phone: 646-888-4227

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To determine if patients have lower rates of hypersensitivity reactions compared to those treated with standard infusion carboplatin.

Secondary outcome:

Determine the rate of successful planned treatment completion of carboplatin in each group

Perform a cost-identification analysis of extended infusion carboplatin to estimate the cost per hypersensitivity reaction prevented.

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.

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Locations and Contacts

Roisin O'Cearbhaill, MDBCh, Phone: 646-888-4227

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States; Recruiting
Roisin O'Cearbhaill, MD BCh, Phone: 646-888-4227
David Hyman, MD, Phone: 646-888-4544
Roisin O'Cearbhaill, MD BCh, Principal Investigator
Additional Information

Memorial Sloan Kettering Cancer Center

Starting date: November 2010
Last updated: August 18, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017