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Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment

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ClinicalTrials.gov Identifier: NCT02035345
Recruitment Status : Terminated (Extended Carboplatin Infusion did not Reduce Frequency of Hypersensitivity Reactions)
First Posted : January 14, 2014
Results First Posted : November 1, 2016
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
Aleena Banerji, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE November 21, 2013
First Posted Date  ICMJE January 14, 2014
Results First Submitted Date  ICMJE August 30, 2016
Results First Posted Date  ICMJE November 1, 2016
Last Update Posted Date December 8, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
  • Number of Participants With Carboplatin Infusion Hypersensitivity Reactions Using a Slowed Carboplatin Infusion Program [ Time Frame: 2 Years ]
    To determine the frequency of carboplatin infusion hypersensitivity reactions using a slowed carboplatin infusion program
  • Number of Patients With Carboplatin Reactions of Different Severity [ Time Frame: 2 Years ]
    To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol.
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2014)
  • To determine the frequency of carboplatin infusion reactions using a slowed carboplatin infusion program [ Time Frame: 2 Years ]
    To determine the frequency of carboplatin infusion reactions using a slowed carboplatin infusion program
  • To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol. [ Time Frame: 2 Years ]
    To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment
Official Title  ICMJE Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment
Brief Summary This is a research study to determine if administering carboplatin at a slower rate when re-treating recurrent ovarian cancer patients prior to the development of a hypersensitivity reaction will decrease the frequency and severity of future hypersensitivity reactions.
Detailed Description

For women with recurrent ovarian cancer, re-treatment with carboplatin is frequently recommended. However, carboplatin re-treatment can result in an allergic or allergic-like reaction called a hypersensitivity reaction. Symptoms of a hypersensitivity reaction can include, but are not limited to itching, rash, swelling of the lips, tongue, or throat, chest pain, chest tightness, shortness of breath, wheezing, abdominal pain, nausea, vomiting, diarrhea, palpitations, dizziness, confusion, and low pressure. Hypersensitivity reactions occur in 20-40% of women with recurrent ovarian cancer who are re-treated with carboplatin. At least half of the hypersensitivity reactions are described as moderately severe with symptoms of generalized rash, wheezing, facial swelling, difficulty breathing/shortness of breath, and hypotension (low blood pressure).

Patients who suffer from a hypersensitivity reaction while receiving carboplatin and require additional therapy may receive future carboplatin infusions utilizing a "desensitization" technique. A desensitization is when carboplatin is administered in slowly increasing amounts as an inpatient under the direction of the department of Allergy Immunology at Massachusetts General Hospital. A desensitization allows patient to safely receive carboplatin, but requires an inpatient hospitalization, which may be of significant inconvenience to some patients.

As part of this study, the participant will continue to receive carboplatin as part of their standard therapy. The change would be instead of carboplatin being administered over a 30 minute period, the carboplatin be administered intravenously according to the following schedule:

  • First hour - Administer 1 percent of total dose
  • Second hour - Administer 9 percent
  • Third hour - Administer 90 percent

Standard pre-medications will be administered immediately prior to the carboplatin infusion which will include of 20 mg of dexamethasone, 50mg of diphenhydramine, and famotidine 20 mg.

The participant's medical record will also be reviewed to evaluate whether age, cancer stage/grade, number of previous carboplatin cycles, accompanying agents, and/or medical conditions have an effect on hypersensitivity reactions. The participant will also be asked to fill out a short optional form regarding race and ethnicity to evaluate whether or not these factors contribute to hypersensitivity reactions.

If the participant experiences a hypersensitivity reaction, the study protocol will be discontinued. A standard blood draw for a tryptase (a blood test for an allergic reaction) will be obtained at the time of the reaction along with other discretionary laboratories recommended by your oncologist. The participant will then be referred to the Allergy Immunology Department if carboplatin is determined to be necessary for future treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Recurrent Ovarian Cancer
  • Platinum Sensitive Ovarian Cancer
Intervention  ICMJE Drug: Carboplatin
Other Names:
  • Paraplatin
  • CBDCA
Study Arms  ICMJE Experimental: Carboplatin

Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:

  • First hour - Administer 1 percent of total dose (5ml with tubing primed)
  • Second hour - Administer 9 percent (45 mL)
  • Third hour - Administer 90 percent (450 mL)
Intervention: Drug: Carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 27, 2016)
15
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2014)
50
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed ovarian cancers for which carboplatin is an acceptable treatment option. In addition, participants must be candidates for systemic chemotherapy as determined by their treating physician.
  • Participants must have received a carboplatin-containing regimen at initial diagnosis. Retreatment is permitted in second or greater line with carboplatin-based chemotherapy.
  • Age ≥ 18 years of age
  • Eastern Cooperative Oncology Group performance status <2 (see Appendix A).
  • Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to initiating chemotherapy on trial and must agree to practice an effective method of birth control, such as an intrauterine device, tubal ligation, or oral contraceptives, during the study and for six months after their last treatment. Women should not breast-feed while on this study
  • Ability to understand and the willingness to sign a written informed consent document
  • Patients must be willing to comply with study design and requirements for participating on the study.
  • Laboratory Criteria for eligibility The following are laboratory criteria for baseline absolute neutrophil count, platelet count, and creatinine for inclusion on this study.

Exclusion Criteria:

  • Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02035345
Other Study ID Numbers  ICMJE 13-413
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aleena Banerji, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aleena Banerji, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date November 2016

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