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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

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ClinicalTrials.gov Identifier: NCT01248962
Recruitment Status : Completed
First Posted : November 25, 2010
Results First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Drug: carboplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in theTreatment of Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer
Actual Study Start Date : November 2010
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Carboplatin

Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With and Without Hypersensitivity Reaction [ Time Frame: 2 years ]
    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


Secondary Outcome Measures :
  1. The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group [ Time Frame: 2 years ]
  2. Perform a Cost-identification Analysis of Extended Infusion Carboplatin to Estimate the Cost Per Hypersensitivity Reaction Prevented. [ Time Frame: 2 years ]
  3. The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate [ Time Frame: 2 years ]
    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 Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248962


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Roisin O'Cearbhaill, MD BCh Memorial Sloan Kettering Cancer Center
  Study Documents (Full-Text)

Documents provided by Memorial Sloan Kettering Cancer Center:
Study Protocol and Statistical Analysis Plan  [PDF] August 15, 2014

More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01248962    
Other Study ID Numbers: 10-184
First Posted: November 25, 2010    Key Record Dates
Results First Posted: October 2, 2019
Last Update Posted: October 2, 2019
Last Verified: June 2019
Keywords provided by Memorial Sloan Kettering Cancer Center:
BEVACIZUMAB (AVASTIN)
CARBOPLATIN
DEXAMETHASONE
GEMCITABINE
LIPODOX(LIPOSOMAL DOXORUBICIN)
 MONTELUKAST (SINGULAR)
TAXOL (PACLITAXEL
Fallopian Tubes
10-184
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Peritoneal Neoplasms
Neoplasms by Site
Neoplasms
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
 Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Carboplatin
Antineoplastic Agents