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

• ClinicalTrials.gov Identifier: NCT02035345
• Recruitment Status: Terminated
• First Posted: January 14, 2014
• Results First Posted: November 1, 2016
• Last Update Posted: December 8, 2016
• Sponsor: Massachusetts General Hospital
• Information provided by (Responsible Party): Aleena Banerji, Massachusetts General Hospital

Tracking Information

• First Submitted Date: November 21, 2013
• First Posted Date: January 14, 2014
• Results First Submitted Date: August 30, 2016
• Results First Posted Date: November 1, 2016
• Last Update Posted Date: December 8, 2016
• Study Start Date: January 2014
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Recurrent Ovarian Cancer
• Platinum Sensitive Ovarian Cancer

Intervention

Drug: Carboplatin

Other Names:

• Paraplatin
• CBDCA

Study Arms

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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 27, 2016): 15
• Original Estimated Enrollment (submitted: January 12, 2014): 50
• Actual Study Completion Date: June 2016
• Actual Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02035345
• Other Study ID Numbers: 13-413
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Aleena Banerji, Massachusetts General Hospital
• Study Sponsor: Massachusetts General Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Aleena Banerji, MD; Massachusetts General Hospital

• PRS Account: Massachusetts General Hospital
• Verification Date: November 2016