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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02035345
Recruitment Status : Terminated (Extended Carboplatin Infusion did not Reduce Frequency of Hypersensitivity Reactions)
First Posted : January 14, 2014
Results First Posted : November 1, 2016
Last Update Posted : December 8, 2016
Information provided by (Responsible Party):
Aleena Banerji, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Recurrent Ovarian Cancer Platinum Sensitive Ovarian Cancer Drug: Carboplatin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment
Study Start Date : January 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2016

Arm Intervention/treatment
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)
Drug: Carboplatin
Other Names:
  • Paraplatin

Primary Outcome Measures :
  1. 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

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02035345

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Aleena Banerji, MD Massachusetts General Hospital
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Responsible Party: Aleena Banerji, Principal Investigator, Massachusetts General Hospital Identifier: NCT02035345    
Other Study ID Numbers: 13-413
First Posted: January 14, 2014    Key Record Dates
Results First Posted: November 1, 2016
Last Update Posted: December 8, 2016
Last Verified: November 2016
Keywords provided by Aleena Banerji, Massachusetts General Hospital:
Recurrent Ovarian Cancer
Platinum Sensitive Ovarian Cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents