Trial Outcomes & Findings for Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in Patients With Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer (NCT NCT01248962)
NCT ID: NCT01248962
Last Updated: 2019-10-02
Results Overview
The primary objective of this study is to determine if patients have lower rates of hypersensitivity reactions by comparing the number of participants with and without hypersensitivity reaction
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
146 participants
Primary outcome timeframe
2 years
Results posted on
2019-10-02
Participant Flow
Participant milestones
| Measure |
Standard 30-minute Infusion
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatin containing chemotherapy regimen.
carboplatin: Carboplatin Standard 30-minute infusion. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg (or famotidine 20mg IV)IV and diphenhydramine 50mg IV before carboplatin infusion.
|
Extended 3-hour Infusion
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatincontaining chemotherapy regimen.
carboplatin: Extended 3-hour infusion carboplatin. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg IV (or famotidine 20mg IV) and diphenhydramine 50mg IV before carboplatin infusion.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
72
|
|
Overall Study
COMPLETED
|
58
|
56
|
|
Overall Study
NOT COMPLETED
|
16
|
16
|
Reasons for withdrawal
| Measure |
Standard 30-minute Infusion
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatin containing chemotherapy regimen.
carboplatin: Carboplatin Standard 30-minute infusion. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg (or famotidine 20mg IV)IV and diphenhydramine 50mg IV before carboplatin infusion.
|
Extended 3-hour Infusion
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatincontaining chemotherapy regimen.
carboplatin: Extended 3-hour infusion carboplatin. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg IV (or famotidine 20mg IV) and diphenhydramine 50mg IV before carboplatin infusion.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Complete Response after 4 Cycles
|
1
|
0
|
|
Overall Study
Complete Response after 3 Cycles
|
0
|
1
|
|
Overall Study
Progression of Disease prior to 5 Cycles
|
12
|
13
|
Baseline Characteristics
Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in Patients With Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Standard 30-minute Infusion
n=74 Participants
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatin containing chemotherapy regimen.
carboplatin: Carboplatin Standard 30-minute infusion. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg (or famotidine 20mg IV)IV and diphenhydramine 50mg IV before carboplatin infusion.
|
Extended 3-hour Infusion
n=72 Participants
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatincontaining chemotherapy regimen.
carboplatin: Extended 3-hour infusion carboplatin. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg IV (or famotidine 20mg IV) and diphenhydramine 50mg IV before carboplatin infusion.
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe primary objective of this study is to determine if patients have lower rates of hypersensitivity reactions by comparing the number of participants with and without hypersensitivity reaction
Outcome measures
| Measure |
Standard 30-minute Infusion
n=58 Participants
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatin containing chemotherapy regimen.
carboplatin: Carboplatin Standard 30-minute infusion. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg (or famotidine 20mg IV)IV and diphenhydramine 50mg IV before carboplatin infusion.
|
Extended 3-hour Infusion
n=56 Participants
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatincontaining chemotherapy regimen.
carboplatin: Extended 3-hour infusion carboplatin. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg IV (or famotidine 20mg IV) and diphenhydramine 50mg IV before carboplatin infusion.
|
|---|---|---|
|
Number of Participants With and Without Hypersensitivity Reaction
Experienced HSR (Hypersensitivity Reaction)
|
9 Participants
|
6 Participants
|
|
Number of Participants With and Without Hypersensitivity Reaction
Did not experience HSR (Hypersensitivity Reaction)
|
49 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Standard 30-minute Infusion
n=58 Participants
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatin containing chemotherapy regimen.
carboplatin: Carboplatin Standard 30-minute infusion. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg (or famotidine 20mg IV)IV and diphenhydramine 50mg IV before carboplatin infusion.
|
Extended 3-hour Infusion
n=56 Participants
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatincontaining chemotherapy regimen.
carboplatin: Extended 3-hour infusion carboplatin. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg IV (or famotidine 20mg IV) and diphenhydramine 50mg IV before carboplatin infusion.
|
|---|---|---|
|
The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group
Planned treatment completion
|
49 Participants
|
50 Participants
|
|
The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group
Planned treatment not completed
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data were not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Among the evaluable 114 participants, 15 experienced a Hypersensitivity Reaction/HSR. 6 of the 56 participants in the extended-infusion group and 9 of the 58 participants in the standard-infusion group. These participants were analyzed as a group as the relationship of baseline variables to the rate of carboplatin HSRs were analyzed.
Perform exploratory analyses to correlate hypersensitivity rate to history of atopy, prior drug allergies, number of lifetime platinum cycles, duration since last platinum, and concomitant chemotherapy agent.
Outcome measures
| Measure |
Standard 30-minute Infusion
n=15 Participants
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatin containing chemotherapy regimen.
carboplatin: Carboplatin Standard 30-minute infusion. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg (or famotidine 20mg IV)IV and diphenhydramine 50mg IV before carboplatin infusion.
|
Extended 3-hour Infusion
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatincontaining chemotherapy regimen.
carboplatin: Extended 3-hour infusion carboplatin. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg IV (or famotidine 20mg IV) and diphenhydramine 50mg IV before carboplatin infusion.
|
|---|---|---|
|
The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate
# of Prior platinum-based regimens (>2 vs 1)
|
2.5 Odds Ratio
Interval 0.8 to 7.5
|
—
|
|
The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate
Prior cisplatin regimen
|
1.5 Odds Ratio
Interval 0.5 to 4.4
|
—
|
|
The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate
Platinum-free interval
|
1 Odds Ratio
Interval 0.96 to 1.0
|
—
|
|
The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate
History of drug allergies
|
0.8 Odds Ratio
Interval 0.3 to 2.4
|
—
|
|
The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate
History of food allergies
|
2.2 Odds Ratio
Interval 0.5 to 9.2
|
—
|
|
The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate
History of atopy
|
2 Odds Ratio
Interval 0.6 to 5.8
|
—
|
Adverse Events
Standard 30-minute Infusion
Serious events: 10 serious events
Other events: 26 other events
Deaths: 57 deaths
Extended 3-hour Infusion
Serious events: 11 serious events
Other events: 24 other events
Deaths: 49 deaths
Serious adverse events
| Measure |
Standard 30-minute Infusion
n=74 participants at risk
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatin containing chemotherapy regimen.
carboplatin: Carboplatin Standard 30-minute infusion. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg (or famotidine 20mg IV)IV and diphenhydramine 50mg IV before carboplatin infusion.
|
Extended 3-hour Infusion
n=72 participants at risk
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatincontaining chemotherapy regimen.
carboplatin: Extended 3-hour infusion carboplatin. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg IV (or famotidine 20mg IV) and diphenhydramine 50mg IV before carboplatin infusion.
|
|---|---|---|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
1.4%
1/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
1/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
1.4%
1/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
1.4%
1/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
12.5%
9/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
1.4%
1/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Investigations
Blood bilirubin increased
|
1.4%
1/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
0.00%
0/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
0.00%
0/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.7%
2/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
0.00%
0/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
0.00%
0/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Investigations
Platelet count decreased
|
1.4%
1/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
0.00%
0/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.7%
2/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
8.3%
6/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.4%
1/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
0.00%
0/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Infections and infestations
Infections and infestations
|
0.00%
0/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
1.4%
1/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
1.4%
1/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
1.4%
1/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
1.4%
1/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
Other adverse events
| Measure |
Standard 30-minute Infusion
n=74 participants at risk
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatin containing chemotherapy regimen.
carboplatin: Carboplatin Standard 30-minute infusion. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg (or famotidine 20mg IV)IV and diphenhydramine 50mg IV before carboplatin infusion.
|
Extended 3-hour Infusion
n=72 participants at risk
This is a non-blinded randomized study comparing standard 30-minute infusion carboplatin to extended 3-hour infusion carboplatin in women with recurrent, ovary, fallopian tube, and primary peritoneal cancer who will be treated with a carboplatincontaining chemotherapy regimen.
carboplatin: Extended 3-hour infusion carboplatin. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg IV (or famotidine 20mg IV) and diphenhydramine 50mg IV before carboplatin infusion.
|
|---|---|---|
|
Immune system disorders
Allergic reaction
|
12.2%
9/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
9.7%
7/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Psychiatric disorders
Anxiety
|
1.4%
1/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
1.4%
1/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Psychiatric disorders
Depression
|
1.4%
1/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
2.8%
2/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
1.4%
1/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Vascular disorders
Flushing
|
1.4%
1/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
1.4%
1/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
9.5%
7/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
13.9%
10/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
1.4%
1/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Psychiatric disorders
Insomnia
|
9.5%
7/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
4.2%
3/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
1.4%
1/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
2.8%
2/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
4.1%
3/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
0.00%
0/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
1.4%
1/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.1%
6/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
6.9%
5/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediastinal disorder
|
1.4%
1/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
0.00%
0/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders
|
1.4%
1/74 • From baseline to up to 3 months after last treatment, up to 2 years
|
1.4%
1/72 • From baseline to up to 3 months after last treatment, up to 2 years
|
Additional Information
Dr. Roisin O'Cearbhaill, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4227
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place