Recurrent Ovarian CancerPhase 4NCT02035345
Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment
A Phase 4 study testing Carboplatin in people with Recurrent Ovarian Cancer and Platinum Sensitive Ovarian Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Ovarian Cancer, Platinum Sensitive Ovarian Cancer
- What is being tested?
- Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
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.
Read the 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.
- Being tested
- Carboplatin
- Keywords
- Recurrent Ovarian Cancer, Platinum Sensitive Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Also called Paraplatin, CBDCA
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin | Experimental | 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) Receives: Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 Years
Number of Patients With Carboplatin Reactions of Different Severity
To characterize the nature and symptoms of carboplatin reactions associated with the slowed infusion protocol.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionJun 2016
Why it stopped: Extended Carboplatin Infusion did not Reduce Frequency of Hypersensitivity Reactions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleena Banerji, Massachusetts General Hospital
- Investigators
- Aleena Banerji, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035345
- Sponsor's protocol ID
- 13-413
- Status last verified
- Nov 2016
- First submitted
- 21 Nov 2013
- Last updated
- 8 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment
- ClinicalTrials.gov ID
- NCT02035345
- Acronym / sponsor ID
- 13-413
- Keywords
- Recurrent Ovarian Cancer, Platinum Sensitive Ovarian Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Extended Carboplatin Infusion did not Reduce Frequency of Hypersensitivity Reactions
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 14 Jan 2014 (estimated)
- Results
- Posted 1 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carboplatin | Experimental | Drug: CarboplatinCarboplatin 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinAlso: Paraplatin, CBDCA | Drug | Carboplatin |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleena Banerji, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carboplatin in people with Recurrent Ovarian Cancer and Platinum Sensitive Ovarian Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Carboplatin Infusion Hypersensitivity Reactions Using a Slowed Carboplatin Infusion Program (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.