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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01248962
First received: November 24, 2010
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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. 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.

Some patients have been given carboplatin over 3 hours instead of 30 minutes. They had fewer allergies than we expected. We do not know if this was because of the way they got carboplatin or because of something else.


Condition Intervention Phase
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Drug: carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To determine if patients have lower rates of hypersensitivity reactions compared to those treated with standard infusion carboplatin. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The primary objective of this study is to perform a randomized study to determine whether patients treated for relapsed ovary, fallopian and primary peritoneal with extended infusion carboplatin.


Secondary Outcome Measures:
  • Determine the rate of successful planned treatment completion of carboplatin in each group [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Perform a cost-identification analysis of extended infusion carboplatin to estimate the cost per hypersensitivity reaction prevented. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: November 2010
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01248962

Contacts
Contact: Roisin O'Cearbhaill, MDBCh 646-888-4227
Contact: David Hyman, MD 646-888-4544

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Roisin O'Cearbhaill, MD BCh    646-888-4227      
Contact: David Hyman, MD    646-888-4544      
Principal Investigator: Roisin O'Cearbhaill, MD BCh         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Roisin O'Cearbhaill, MD BCh Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01248962     History of Changes
Other Study ID Numbers: 10-184
Study First Received: November 24, 2010
Last Updated: August 15, 2014
Health Authority: United States: Institutional Review Board

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
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms
Carboplatin
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 20, 2014