Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in Patients With Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer
Conditions
Ovarian Cancer - Fallopian Tube Cancer - Peritoneal Cancer
Conditions: official terms
Peritoneal Neoplasms
Conditions: Keywords
BEVACIZUMAB (AVASTIN), CARBOPLATIN, DEXAMETHASONE, GEMCITABINE, LIPODOX(LIPOSOMAL DOXORUBICIN), MONTELUKAST (SINGULAR), TAXOL (PACLITAXEL, Fallopian Tubes, 10-184
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: carboplatin Type: Drug
Name: carboplatin Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 21 Years
Gender: 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
Location
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Roisin O'Cearbhaill, MD BCh - 646-888-4227
Start Date
November 2010
Completion Date
November 2015
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page