Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment
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.
Recurrent Ovarian Cancer
Platinum Sensitive Ovarian Cancer
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment|
- To determine the frequency of carboplatin infusion reactions using a slowed carboplatin infusion program [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||November 2018|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
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:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02035345
|Contact: Aleena Banerji, MD||(617) firstname.lastname@example.org|
|Contact: Timothy Lax, MD||(617) email@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Aleena Banerji, MD 617-726-3850 firstname.lastname@example.org|
|Contact: Timothy Lax, MD (617) 726-3850 email@example.com|
|Principal Investigator: Aleena Banerji, MD|
|Principal Investigator:||Aleena Banerji, MD||Massachusetts General Hospital|