A Phase 4 interventional study of Carboplatin in Recurrent Ovarian Cancer and Platinum Sensitive Ovarian Cancer, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-08.
Sponsored by Massachusetts General Hospital · Phase 4, Interventional, and Supportive care
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.
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:
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 15 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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Exclusion Criteria:
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)
Drug: Carboplatin
Also known as: Paraplatin, CBDCA
Number of Participants With Carboplatin Infusion Hypersensitivity Reactions Using a Slowed Carboplatin Infusion Program
To determine the frequency of carboplatin infusion hypersensitivity reactions using a slowed carboplatin infusion program
Time frame: 2 Years
Number of Patients With Carboplatin Reactions of Different Severity
To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol.
Time frame: 2 Years
| Milestone | Carboplatin |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
To determine the frequency of carboplatin infusion hypersensitivity reactions using a slowed carboplatin infusion program
| participants | Carboplain Slowed Infusion Group Reactors |
|---|---|
| Number of Participants With Carboplatin Infusion Hypersensitivity Reactions Using a Slowed Carboplatin Infusion Program | 6 |
To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol.
| participants | Carboplatin |
|---|---|
| Grade 2 | 3 |
| Grade 3 | 2 |
| Grade 4 | 1 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Carboplatin | — | 1/15 (6.7%) | 6/15 (40%) |
| Event | Carboplatin |
|---|---|
| AnaphylaxisImmune system disorders | 1/15 |
| Event | Carboplatin |
|---|---|
| Hypersensitivity ReactionImmune system disorders | 5/15 |
| VomitingGastrointestinal disorders | 1/15 |
| HypokalemiaBlood and lymphatic system disorders | 1/15 |
| Age, Categorical(Participants) | Carboplatin |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 7 |
| >=65 years | 8 |
| Gender(Participants) | Carboplatin |
|---|---|
| Female | 15 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Carboplatin |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 13 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Carboplatin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 13 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
This study is terminated, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital