Lung Cancer Clinical Trial
Official title:
A Phase 1/2 Study With Satraplatin and Simultaneous Radiation in Locally Advanced Non-Small Cell Lung Cancer
Verified date | August 2012 |
Source | Agennix |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
PURPOSE: This trial is designed to compare the combination of the investigational oral
cytotoxic drug, satraplatin, and radiation therapy for patients with locally advanced
Non-Small Cell Lung Cancer (NSCLC) with no prior chemotherapy or radiation therapy
treatment. Please refer to the Eligibility Criteria below for key inclusion and exclusion
criteria.
WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a
member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been
clinically proven to be one of the most effective classes of anticancer therapies. Unlike
the currently marketed platinum-based drugs, satraplatin can be given orally.
RATIONALE: Intravenously administered platinum-based drugs are currently used in combination
with radiation therapy in the treatment of patients with locally advanced NSCLC. The purpose
of this Phase I trial is to determine a tolerable dose and schedule for the oral platinum
drug (satraplatin) when given to NSCLC patients throughout the course of their radiotherapy
treatment.
Status | Terminated |
Enrollment | 20 |
Est. completion date | February 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Locally advanced or medically inoperable NSCLC (stage II or III) - ECOG performance status score 0-2 - Adequate bone marrow, liver, and pulmonary functions - Life expectancy > three months. Exclusion Criteria: - Prior malignancy - Serious concurrent uncontrolled medical disorder. - Uncontrolled or significant cardiovascular disease - History of mastectomy - Pregnant or breast-feeding patients are not eligible - Prior radiotherapy to the primary tumor site or cytotoxic chemotherapy |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Agennix |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of MTD and recommended dose for phase II trials | 30 days | Yes |
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