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

NCT01248962 | Completed Phase 2 Results DMC

• 1 other identifier: 10-184
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Secondary Outcomes (3)

• 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

Study Arms (2)

Standard 30-minute infusion

EXPERIMENTAL

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

extended 3-hour infusion

EXPERIMENTAL

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

Interventions

carboplatin DRUG

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.

Standard 30-minute infusion

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior carboplatin or cisplatin hypersensitivity reaction
• 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

Sponsors & Collaborators

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

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube 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; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Dr. Roisin O'Cearbhaill, MD
• Organization: Memorial Sloan Kettering Cancer Center

ocearbhr@mskcc.org

646-888-4227

Study Officials

• Roisin O'Cearbhaill, MD BCh

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: November 25, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: October 2, 2019
• Results First Posted: October 2, 2019

Record last verified: 2019-06

Locations

US (1)