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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Aleena Banerji, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02035345
First received: November 21, 2013
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Recurrent Ovarian Cancer
Platinum Sensitive Ovarian Cancer
Drug: Carboplatin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To determine the frequency of carboplatin infusion reactions using a slowed carboplatin infusion program [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol.


Estimated Enrollment: 50
Study Start Date: January 2014
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • CBDCA

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02035345

Contacts
Contact: Aleena Banerji, MD (617) 726-3850 tlax@partners.org
Contact: Timothy Lax, MD (617) 726-3850 abanerji@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Aleena Banerji, MD    617-726-3850    abanerji@partners.org   
Contact: Timothy Lax, MD    (617) 726-3850    tlax@partners.org   
Principal Investigator: Aleena Banerji, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Aleena Banerji, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Aleena Banerji, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02035345     History of Changes
Other Study ID Numbers: 13-413
Study First Received: November 21, 2013
Last Updated: September 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Recurrent Ovarian Cancer
Platinum Sensitive Ovarian Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Carboplatin
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014