Slowed Carboplatin Infusion for Ovarian Cancer Patients Receiving Carboplatin Re-Treatment

NCT02035345 | Terminated Phase 4 Results DMC

• 1 other identifier: 13-413
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Ovarian Cancer; Platinum Sensitive Ovarian Cancer

Keywords

Recurrent Ovarian Cancer; Platinum Sensitive Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  2 Years

Study Arms (1)

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)

Drug: Carboplatin

Interventions

Carboplatin DRUG

Also known as: Paraplatin, CBDCA

Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Dr. Aleena Banerji
• Organization: Massachusetts General Hospital

abanerji@mgh.harvard.edu

6177263850

Study Officials

• Aleena Banerji, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: January 14, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2016
• Last Updated: December 8, 2016
• Results First Posted: November 1, 2016

Record last verified: 2016-11

Locations

US (1)