Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in Patients With Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01248962
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 146
• Location: 1
• Arms: 2
• Actual Duration (Months): 93
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer	Drug: carboplatin; Drug: carboplatin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 146 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in theTreatment of Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer
• Actual Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Aug 1, 2018
• Actual Study Completion Date: Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.
Experimental: 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.	Drug: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group [2 years]

2. Perform a Cost-identification Analysis of Extended Infusion Carboplatin to Estimate the Cost Per Hypersensitivity Reaction Prevented. [2 years]

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Roisin O'Cearbhaill, MD BCh, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 15, 2014

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT01248962
• Other Study ID Numbers: 10-184
• First Posted: Nov 25, 2010
• Last Update Posted: Oct 2, 2019
• Last Verified: Jun 1, 2019

• Keywords provided by Memorial Sloan Kettering Cancer Center: BEVACIZUMAB (AVASTIN); CARBOPLATIN; DEXAMETHASONE; GEMCITABINE; LIPODOX(LIPOSOMAL DOXORUBICIN); MONTELUKAST (SINGULAR); TAXOL (PACLITAXEL; Fallopian Tubes; 10-184
• Additional relevant MeSH terms: Fallopian Tube Neoplasms; Peritoneal Neoplasms; Carboplatin

Study Results

Participant Flow

Arm/Group Title	Standard 30-minute Infusion	Extended 3-hour Infusion
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	74	72
COMPLETED	58	56
NOT COMPLETED	16	16

Baseline Characteristics

Arm/Group Title	Standard 30-minute Infusion	Extended 3-hour Infusion	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	74	72	146
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	39 52.7%	50 69.4%	89 61%
>=65 years	35 47.3%	22 30.6%	57 39%
Sex: Female, Male (Count of Participants)
Female	74 100%	72 100%	146 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1.4%	4 5.6%	5 3.4%
Native Hawaiian or Other Pacific Islander	1 1.4%	0 0%	1 0.7%
Black or African American	3 4.1%	5 6.9%	8 5.5%
White	66 89.2%	62 86.1%	128 87.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 4.1%	1 1.4%	4 2.7%
Region of Enrollment (Count of Participants)
United States	74 100%	72 100%	146 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With and Without Hypersensitivity Reaction
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard 30-minute Infusion	Extended 3-hour Infusion
Arm/Group Description	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.	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.
Measure Participants	58	56
Experienced HSR (Hypersensitivity Reaction)	9 12.2%	6 8.3%
Did not experience HSR (Hypersensitivity Reaction)	49 66.2%	50 69.4%

2. Secondary Outcome

Title	The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard 30-minute Infusion	Extended 3-hour Infusion
Arm/Group Description	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.	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.
Measure Participants	58	56
Planned treatment completion	49 66.2%	50 69.4%
Planned treatment not completed	9 12.2%	6 8.3%

3. Secondary Outcome

Title	Perform a Cost-identification Analysis of Extended Infusion Carboplatin to Estimate the Cost Per Hypersensitivity Reaction Prevented.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Data were not collected

Arm/Group Title	Standard 30-minute Infusion	Extended 3-hour Infusion
Arm/Group Description	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.	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.
Measure Participants	0	0

4. Secondary Outcome

Title	The Odds Ratio for the Relationship of Baseline Variables to the Carboplatin Hypersensitivity Rate
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Participants Who Experienced HSR
Arm/Group Description	Participants who Experienced Hypersensitivity Reaction
Measure Participants	15
# of Prior platinum-based regimens (>2 vs 1)	2.5
Prior cisplatin regimen	1.5
Platinum-free interval	1
History of drug allergies	0.8
History of food allergies	2.2
History of atopy	2

Adverse Events

Time Frame	From baseline to up to 3 months after last treatment, up to 2 years
Arm/Group Title	Standard 30-minute Infusion		Extended 3-hour Infusion
Arm/Group Description	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.		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.
All Cause Mortality
	Standard 30-minute Infusion		Extended 3-hour Infusion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	57/74 (77%)		49/72 (68.1%)
Serious Adverse Events
	Standard 30-minute Infusion		Extended 3-hour Infusion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/74 (13.5%)		11/72 (15.3%)
Blood and lymphatic system disorders
Anemia	1/74 (1.4%)		1/72 (1.4%)
Febrile neutropenia	2/74 (2.7%)		0/72 (0%)
Cardiac disorders
Supraventricular tachycardia	1/74 (1.4%)		0/72 (0%)
Gastrointestinal disorders
Ascites	1/74 (1.4%)		1/72 (1.4%)
Small intestinal obstruction	2/74 (2.7%)		6/72 (8.3%)
Lower gastrointestinal hemorrhage	0/74 (0%)		1/72 (1.4%)
Upper gastrointestinal hemorrhage	0/74 (0%)		1/72 (1.4%)
Infections and infestations
Abdominal Infection	0/74 (0%)		1/72 (1.4%)
Infections and infestations	0/74 (0%)		1/72 (1.4%)
Investigations
Blood bilirubin increased	1/74 (1.4%)		0/72 (0%)
Platelet count decreased	1/74 (1.4%)		0/72 (0%)
Metabolism and nutrition disorders
Anorexia	1/74 (1.4%)		9/72 (12.5%)
Dehydration	1/74 (1.4%)		0/72 (0%)
Musculoskeletal and connective tissue disorders
Pain in extremity	1/74 (1.4%)		0/72 (0%)
Vascular disorders
Thromboembolic event	0/74 (0%)		1/72 (1.4%)
Other (Not Including Serious) Adverse Events
	Standard 30-minute Infusion		Extended 3-hour Infusion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/74 (35.1%)		24/72 (33.3%)
Immune system disorders
Allergic reaction	9/74 (12.2%)		7/72 (9.7%)
Metabolism and nutrition disorders
Hyperglycemia	7/74 (9.5%)		10/72 (13.9%)
Metabolism and nutrition disorders	1/74 (1.4%)		2/72 (2.8%)
Psychiatric disorders
Anxiety	1/74 (1.4%)		1/72 (1.4%)
Depression	1/74 (1.4%)		2/72 (2.8%)
Insomnia	7/74 (9.5%)		3/72 (4.2%)
Respiratory, thoracic and mediastinal disorders
Resp, thoracic & mediastinal disorder	1/74 (1.4%)		0/72 (0%)
Skin and subcutaneous tissue disorders
Erythema multiforme	0/74 (0%)		1/72 (1.4%)
Hyperhidrosis	0/74 (0%)		1/72 (1.4%)
Palmar-plantar erythrodysesthesia syndrome	3/74 (4.1%)		0/72 (0%)
Pruritus	0/74 (0%)		1/72 (1.4%)
Rash maculo-papular	6/74 (8.1%)		5/72 (6.9%)
Skin & subcutaneous tissue disorders	1/74 (1.4%)		1/72 (1.4%)
Vascular disorders
Flushing	1/74 (1.4%)		1/72 (1.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.