A Study Of Ranpirnase(Onconase®) To Pemetrexed Plus Carboplatin In Patients With Non-Squamous Non-Small Cell Lung Cancer

Non-Small Cell Lung Cancer Clinical Trial

Official title:

A Phase II Trial of Addition of Ranpirnase(ONCONASE®) to Permetrexed Plus Carboplatin in Patientes With Non-Squamous Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01184287
• Other study ID #: P30-800
• Status: Withdrawn
• Phase: Phase 2
• First received: August 17, 2010
• Last updated: August 31, 2015

Study information

• Verified date: August 2015
• Source: Tamir Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the trial is to determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed—carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater than 18 years

• ECOG less than 2

• Estimated survival of greater than 12 weeks

Exclusion Criteria:

• Prior systemic chemotherapy for locally advanced or metastatic NSCLC

• Use of any investigational agent within 28 days prior to registration

• Known hypersensitivity to any of the study drugs

• Brain metastases or leptomeningeal disease

• History of prior malignancy within the past three years

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Ranpirnase
Cycles 3 and until patient progression, on days 1,8 and 15 in a 21 day cycle

Locations

Country	Name	City	State
United States	Tower Cancer Research Foundation	Beverly Hills	California
United States	Tri-county Hematology-Oncology Associates, Inc	Canton	Ohio
United States	Van Andel Research Institute	Grand Rapids	Michigan
United States	Sletten Cancer Specialists	Great Falls	Montana
United States	The Cancer Institute at NYU Langone Medical Center	New York	New York
United States	Northern Utah Associates	Ogden	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Tamir Biotechnology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response	To determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed—carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy	4 or more months	No
Secondary	Progression Free Survival (PFS)	To determine the PFS in patients with SD, PR or CR following 2 cycles of doublet chemotherapy	2 years	Yes
Secondary	Survival	To determine the survival of patients with SD, PR or CR following 2 cycles of doublet chemotherapy	2 years	Yes