Platinum Sensitive Ovarian Cancer, Recurrent Ovarian Cancer
Conditions
Keywords
Recurrent Ovarian Cancer, Platinum Sensitive Ovarian Cancer
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.
Interventions
DRUGCarboplatin
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Carboplatin Infusion Hypersensitivity Reactions Using a Slowed Carboplatin Infusion Program | 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 | 2 Years | To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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)
Carboplatin | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Carboplatin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Gender Female | 15 Participants |
| Gender Male | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 15 |
| serious Total, serious adverse events | 1 / 15 |
Outcome results
Primary
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
Population: Total number of patients in the study that received carboplatin via slowed infusion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Carboplain Slowed Infusion Group Reactors | Number of Participants With Carboplatin Infusion Hypersensitivity Reactions Using a Slowed Carboplatin Infusion Program | 6 participants |
Primary
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
Population: Among the 15 patients enrolled, the HSR rate was 40% which occurred after a median of 2 protocol treatments, which prompted early termination of this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Carboplain Slowed Infusion Group Reactors | Number of Patients With Carboplatin Reactions of Different Severity | Grade 2 | 3 participants |
| Carboplain Slowed Infusion Group Reactors | Number of Patients With Carboplatin Reactions of Different Severity | Grade 3 | 2 participants |
| Carboplain Slowed Infusion Group Reactors | Number of Patients With Carboplatin Reactions of Different Severity | Grade 4 | 1 participants |