Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-02 @ 12:28 AM
Study NCT ID:
NCT00859469
Status:
COMPLETED
Last Update Posted:
2019-10-30
First Post:
2009-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Oxaliplatin (Eloxatin®) Plus Gemcitabine as First or Second-line Chemotherapy for Patients With Malignant Pleural or Peritoneal Mesothelioma: A Phase II Clinical Trial
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In patients with pleural or peritoneal mesothelioma, what is the response rate to combined Oxaliplatin (ELOXATIN®) and Gemcitabine chemotherapy?
Detailed Description:
Oxaliplatin (ELOXATIN®) is an organoplatinum complex which exerts its cytotoxic effect chiefly through inhibition of tumoral DNA synthesis and repair, leading to cellular apoptosis. The antiproliferative activity of oxaliplatin has been shown to approximate that of cisplatin or carboplatin in different tumor types.
This is a phase II clinical trial of Oxaliplatin (ELOXATIN®) plus gemcitabine as first or secondline chemotherapy for patients with malignant pleural or peritoneal mesothelioma. This study aims to determine the objective tumor response rate for Oxaliplatin plus gemcitabine given every 14 days in patients with malignant pleural mesothelioma and/or malignant peritoneal mesothelioma who have no more than one prior chemotherapy regimen. A total of 29 patients are expected to be enrolled in the study, each with a participation duration of 6 months.
Patients will be screened using standard health care assessments and tests. All of these tests must be done within 4 weeks before patients begin treatment. Patients who are deemed eligible will start the treatment cycle, defined as an interval of 14 days, and comprising of treatment with Gemcitabine followed immediately by Oxaliplatin. The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.
In the absence of specific indications for discontinuation of study drugs, patients will routinely be offered 6 cycles of therapy. Further cycles may be given if in the opinion of the investigator this is in the patient's best interest.
This is a phase II clinical trial of Oxaliplatin (ELOXATIN®) plus gemcitabine as first or secondline chemotherapy for patients with malignant pleural or peritoneal mesothelioma. This study aims to determine the objective tumor response rate for Oxaliplatin plus gemcitabine given every 14 days in patients with malignant pleural mesothelioma and/or malignant peritoneal mesothelioma who have no more than one prior chemotherapy regimen. A total of 29 patients are expected to be enrolled in the study, each with a participation duration of 6 months.
Patients will be screened using standard health care assessments and tests. All of these tests must be done within 4 weeks before patients begin treatment. Patients who are deemed eligible will start the treatment cycle, defined as an interval of 14 days, and comprising of treatment with Gemcitabine followed immediately by Oxaliplatin. The study drugs will be administered in the following manner: Gemcitabine, at 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin, at 100 mg/m² IV infusion over 2 hours.
In the absence of specific indications for discontinuation of study drugs, patients will routinely be offered 6 cycles of therapy. Further cycles may be given if in the opinion of the investigator this is in the patient's best interest.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: