Eloxatin® Plus Gemcitabine Chemotherapy for Mesothelioma

NCT00859469 | Completed Phase 2 Results DMC

• 1 other identifier: AAAA2861
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with pleural or peritoneal mesothelioma, what is the response rate to combined Oxaliplatin (ELOXATIN®) and Gemcitabine chemotherapy?

Conditions

Mesothelioma

Keywords

Mesothelioma

Outcome Measures

Primary Outcomes (1)

• Best Response

  Radiologic response by RECIST criteria will be compared between baseline and at 2 months. Disease assessment: Two objective status determinations of CR before progression are required for a best response of CR. Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. Two determinations of stable/no response or better before progression, but not qualifying as CR or PR are required for a best response of stable/no response.

  Two months

Secondary Outcomes (2)

• Overall Survival

  50 months

• Progression-free Survival

  50 months

Study Arms (1)

Oxaliplatin and Gemcitabine

EXPERIMENTAL

Gemcitabine 1000 mg/m² IV infusion over 90 minutes, then Oxaliplatin 100 mg/m² IV infusion over 2 hours repeated for 14 days up to 6 cycles

Drug: Oxaliplatin; Drug: Gemcitabine

Interventions

Oxaliplatin DRUG

Oxaliplatin 100 mg/m2 IV infusion for 2 hours

Also known as: Eloxatin

Oxaliplatin and Gemcitabine

Gemcitabine DRUG

Gemcitabine 1000mg/m2 IV infusion for 90 minutes

Also known as: Gemzar

Oxaliplatin and Gemcitabine

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically confirmed malignant pleural or peritoneal mesothelioma epithelial, sarcomatoid, or mixed subtype, not amenable to curative treatment with surgery. Patients with pleural mesothelioma will be clinically staged using the International Mesothelioma Interest Group staging criteria. Note that there is no staging system for peritoneal mesothelioma and those patients will only be followed for survival. Patients may be entered based on local pathology.
• Disease status must be that of measurable disease as defined by modified Southwest Oncology Group (SWOG) criteria.
• Measurable disease: The presence of at least one measurable lesion. If only one lesion is present, the neoplastic nature of the disease site should be confirmed by histology.
• Measurable lesions: Lesions that can be accurately measured in at least one dimension with the longest diameter ≥20 mm using conventional techniques or ≥10 mm using spiral computerized tomography (CT) scans. At least one level must have one rind measurement ≥15 mm.
• CT (specifically spiral CT) scans and magnetic resonance imaging (MRI) are the preferred methods of measurement.
• Clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes).
• For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion is required.
• NOTE: Neither pleural effusions nor positive bone scans are considered measurable.
• Patients may have undergone pleurodesis. If pleurodesis was performed, there must be at least a 2-week delay before Oxaliplatin or gemcitabine is administered. If the original CT scan occurred prior to the pleurodesis, an additional CT scan is required 2 weeks or longer after the pleurodesis, which will then be considered the baseline scan.
• NOTE: For patients with clinically significant pleural effusions or ascites, consideration should be given to draining the fluid.
• Performance status of 0, 1 or 2 on Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (after any palliative measures including pleural drainage have occurred).
• Estimated life expectancy of at least 12 weeks.

You may not qualify if:

• More than one previous regimen of systemic chemotherapy. Prior intracavitary cytotoxic drugs will count as a prior regimen, unless given for the purpose of pleurodesis. Immunomodulators will not be regarded as chemotherapy. Prior systemic treatment with pemetrexed plus a platinum compound will not be a contraindication for gemcitabine-oxaliplatin.
• Prior radiation therapy to the target lesion, unless the lesion is clearly progressing and the interval between the most recent radiation therapy and enrollment is at least 4 weeks.
• Active infection (at the discretion of the investigator).
• Pregnancy or breast feeding.
• Serious concomitant systemic disorders (including oncologic emergencies) incompatible with the study (at the discretion of the investigator).
• Patients with a "currently active" second malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix are not to be registered. Patients who are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse.
• Use of any investigational agent within 4 weeks before enrollment into the study.
• Disease which cannot be radiologically imaged.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Mesothelioma

Interventions

Oxaliplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Joshua Leinwand
• Organization: Columbia University

jcl2125@columbia.edu

212-305-4076

Study Officials

• Robert N Taub, MD, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: March 9, 2009
• First Posted: March 11, 2009
• Study Start: April 1, 2004
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2013
• Last Updated: October 30, 2019
• Results First Posted: February 24, 2012

Record last verified: 2019-10

Locations

US (1)