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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01248962
First received: November 24, 2010
Last updated: August 15, 2014
Last verified: August 2014

November 24, 2010
August 15, 2014
November 2010
November 2015   (final data collection date for primary outcome measure)
To determine if patients have lower rates of hypersensitivity reactions compared to those treated with standard infusion carboplatin. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
The primary objective of this study is to perform a randomized study to determine whether patients treated for relapsed ovary, fallopian and primary peritoneal with extended infusion carboplatin.
Same as current
Complete list of historical versions of study NCT01248962 on ClinicalTrials.gov Archive Site
  • Determine the rate of successful planned treatment completion of carboplatin in each group [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Perform a cost-identification analysis of extended infusion carboplatin to estimate the cost per hypersensitivity reaction prevented. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 2 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in Patients With Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer
Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in theTreatment of Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • Drug: carboplatin
    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.
  • Drug: carboplatin
    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.
  • Experimental: Standard 30-minute infusion
    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.
    Intervention: Drug: carboplatin
  • Experimental: extended 3-hour infusion
    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.
    Intervention: Drug: carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
November 2015
November 2015   (final data collection date for primary outcome measure)

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
Female
21 Years and older
No
Contact: Roisin O'Cearbhaill, MDBCh 646-888-4227
Contact: David Hyman, MD 646-888-4544
United States
 
NCT01248962
10-184
Yes
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
National Institutes of Health (NIH)
Principal Investigator: Roisin O'Cearbhaill, MD BCh Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP