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

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.

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.