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

Primary Purpose

Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

carboplatin

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring BEVACIZUMAB (AVASTIN), CARBOPLATIN, DEXAMETHASONE, GEMCITABINE, LIPODOX(LIPOSOMAL DOXORUBICIN), MONTELUKAST (SINGULAR), TAXOL (PACLITAXEL, Fallopian Tubes, 10-184

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 Any such conditions that have occurred in the last 6 months but are no longer active at the time of registration are not considered exclusionary.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

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Standard 30-minute infusion

extended 3-hour infusion

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group

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

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.

Full Information

NCT ID

NCT01248962

First Posted

November 24, 2010

Last Updated

October 1, 2019

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT01248962

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

November 2010 (Actual)

Primary Completion Date

August 2018 (Actual)

Study Completion Date

August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Keywords

BEVACIZUMAB (AVASTIN), CARBOPLATIN, DEXAMETHASONE, GEMCITABINE, LIPODOX(LIPOSOMAL DOXORUBICIN), MONTELUKAST (SINGULAR), TAXOL (PACLITAXEL, Fallopian Tubes, 10-184

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

146 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard 30-minute infusion

Arm Type

Experimental

Arm Description

Arm Title

extended 3-hour infusion

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

carboplatin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

carboplatin

Intervention Description

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.

Primary Outcome Measure Information:

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

Secondary Outcome Measure Information:

Title

The Number of People With Successful Planned Treatment Completion of Carboplatin in Each Group

Time Frame

2 years

Title

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

Time Frame

2 years

Title

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

Description

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roisin O'Cearbhaill, MD BCh

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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