Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer
Conditions
Keywords
BEVACIZUMAB (AVASTIN), CARBOPLATIN, DEXAMETHASONE, GEMCITABINE, LIPODOX(LIPOSOMAL DOXORUBICIN), MONTELUKAST (SINGULAR), TAXOL (PACLITAXEL, Fallopian Tubes, 10-184
Brief summary
Patients who have this kind of cancer are often treated with several drugs. Carboplatin is one that seems to work for many treatment cycles. Even though it may work against the cancer, the patient can become allergic to it. If that happens, they would have to stop taking the drug. The standard way to give carboplatin is by vein over 30 minutes. Some people have been given carboplatin over 3 hours rather than 30 minutes and had fewer allergies than expected. The purpose of this study is to: Find out if giving carboplatin over three hours can prevent the allergy. See if medicine given before the carboplatin can help reduce the risk of allergic reactions.
Interventions
DRUGcarboplatin
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.
Sponsors
National Institutes of Health (NIH)
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* MSKCC Histologically confirmed ovarian, fallopian tube or primary peritoneal carcinoma. * Patient has received at least one prior platinum-containing (cisplatin or carboplatin) regimen * Age ≥ 21 years old * Karnofsky Performance Status (KPS) \> or = to 70% * Adequate hematologic, hepatic and renal function as defined below: * Hemoglobin ≥ 7.0 g/dl * Absolute neutrophil count ≥ 1,000/mm3 * Platelet count ≥ 100,000/mm3 * Serum creatinine ≤ 1.5 x the upper limit of normal or calculated creatinine clearance ≥ 60 mL/min
Exclusion criteria
* Prior carboplatin or cisplatin hypersensitivity reaction * Uncontrolled intercurrent illness including infection, congestive heart failure, myocardial infarction, transient ischemic attack or stroke within 6 months. Any such conditions that have occurred in the last 6 months but are no longer active at the time of registration are not considered exclusionary. * Patients receiving other investigational agents * Patients with HIV disease will be permitted, only if they are on effective antiretroviral therapy, have a CD4 count greater than 400, and have had no opportunistic infections within the past 6 months * Pregnant or lactating women * Life expectancy of less than 12 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With and Without Hypersensitivity Reaction | 2 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group | 2 years | — |
| Perform a Cost-identification Analysis of Extended Infusion Carboplatin to Estimate the Cost Per Hypersensitivity Reaction Prevented. | 2 years | — |
| The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate | 2 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 74 |
| 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. | 72 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 |
| Overall Study | Complete Response after 3 Cycles | 0 | 1 |
| Overall Study | Complete Response after 4 Cycles | 1 | 0 |
| Overall Study | Progression of Disease prior to 5 Cycles | 12 | 13 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Extended 3-hour Infusion | Total | Standard 30-minute Infusion |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 22 Participants | 57 Participants | 35 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 89 Participants | 39 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) White | 62 Participants | 128 Participants | 66 Participants |
| Region of Enrollment United States | 72 Participants | 146 Participants | 74 Participants |
| Sex: Female, Male Female | 72 Participants | 146 Participants | 74 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 57 / 74 | 49 / 72 |
| other Total, other adverse events | 26 / 74 | 24 / 72 |
| serious Total, serious adverse events | 10 / 74 | 11 / 72 |
Outcome results
Primary
Number of Participants With and Without Hypersensitivity Reaction
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
Time frame: 2 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard 30-minute Infusion | Number of Participants With and Without Hypersensitivity Reaction | Experienced HSR (Hypersensitivity Reaction) | 9 Participants |
| Standard 30-minute Infusion | Number of Participants With and Without Hypersensitivity Reaction | Did not experience HSR (Hypersensitivity Reaction) | 49 Participants |
| Extended 3-hour Infusion | Number of Participants With and Without Hypersensitivity Reaction | Experienced HSR (Hypersensitivity Reaction) | 6 Participants |
| Extended 3-hour Infusion | Number of Participants With and Without Hypersensitivity Reaction | Did not experience HSR (Hypersensitivity Reaction) | 50 Participants |
Secondary
Perform a Cost-identification Analysis of Extended Infusion Carboplatin to Estimate the Cost Per Hypersensitivity Reaction Prevented.
Time frame: 2 years
Population: Data were not collected
Secondary
The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group
Time frame: 2 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard 30-minute Infusion | The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group | Planned treatment completion | 49 Participants |
| Standard 30-minute Infusion | The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group | Planned treatment not completed | 9 Participants |
| Extended 3-hour Infusion | The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group | Planned treatment completion | 50 Participants |
| Extended 3-hour Infusion | The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group | Planned treatment not completed | 6 Participants |
Secondary
The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate
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.
Time frame: 2 years
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard 30-minute 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 |
| Standard 30-minute Infusion | The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate | Prior cisplatin regimen | 1.5 Odds Ratio |
| Standard 30-minute Infusion | The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate | Platinum-free interval | 1 Odds Ratio |
| Standard 30-minute Infusion | The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate | History of drug allergies | 0.8 Odds Ratio |
| Standard 30-minute Infusion | The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate | History of food allergies | 2.2 Odds Ratio |
| Standard 30-minute Infusion | The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate | History of atopy | 2 Odds Ratio |