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.
Verified February 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01248962
First received: November 24, 2010
Last updated: February 28, 2013
Last verified: February 2013
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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:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Carboplatin
Montelukast sodium
Montelukast
U.S. FDA Resources
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: | 114 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (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
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: | February 28, 2013 |
| 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:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Dexamethasone Carboplatin Montelukast Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013