Back to resultsSafety Study of Imexon Plus Docetaxel in Lung, Breast or Prostate Cancer Patients
Primary Purpose
Non-small Cell Lung Cancer, Breast Cancer, Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
imexon
docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Hormone refractory prostate cancer
Eligibility Criteria
Inclusion Criteria: Be diagnosed with previously treated breast, lung, or prostate cancer where docetaxel is indicated. Prior treatment; at least one prior regimen required. Able to perform the activities of daily living. Off prior cancer therapy for at least 4 weeks. If female neither pregnant nor nursing. Willing to use contraceptives to prevent pregnancy. No other serious illnesses. No other active malignancy. No serious infections. No other current drug therapy for the cancer. Blood counts and blood chemistries in or near normal range. Prior radiation is permitted. Exclusion Criteria: Active brain metastases.
Sites / Locations
- Investigational Site 008
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Docetaxel plus imexon
Outcomes
Primary Outcome Measures
Determine the tolerability
determine the maximally tolerated dose (MTD)
determine the dose limiting toxicities (DLT) of increasing doses of imexon in combination with standard doses of docetaxel
correlate changes in plasma glutathione (GSH) levels with imexon dose levels
Secondary Outcome Measures
Record any objective tumor responses which may occur
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00327288
Brief Title
Safety Study of Imexon Plus Docetaxel in Lung, Breast or Prostate Cancer Patients
Official Title
A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Taxotere® (Docetaxel) in Previously Treated Inoperable Stage III and Stage IV Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic Previously Treated Breast Cancer or Hormone Refractory Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AmpliMed Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Protocol AMP-010 is a Phase 1b study of imexon plus docetaxel for patients with previously treated breast cancer, previously treated lung cancer or hormone refractory prostate cancer. Docetaxel is approved by the Food and Drug Administration (FDA) as a second line therapy for these cancers. The imexon is administered on days 1-5 and the docetaxel on day 1 of every 3 week cycle. The objective of the protocol is to determine the highest dose of imexon which can be given with a full dose of docetaxel, and to provide information to enable the design of a future study focused on one or more specific cancer types.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Breast Cancer, Prostate Cancer
Keywords
Hormone refractory prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Docetaxel plus imexon
Intervention Type
Drug
Intervention Name(s)
imexon
Other Intervention Name(s)
Amplimexon
Intervention Description
IV variable dosages, days 1-5 every 21 days for duration of study
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
Taxotere
Intervention Description
IV once every 21 days for duration of study
Primary Outcome Measure Information:
Title
Determine the tolerability
Time Frame
duration of study
Title
determine the maximally tolerated dose (MTD)
Time Frame
duration of study
Title
determine the dose limiting toxicities (DLT) of increasing doses of imexon in combination with standard doses of docetaxel
Time Frame
duration of study
Title
correlate changes in plasma glutathione (GSH) levels with imexon dose levels
Time Frame
cycle 1
Secondary Outcome Measure Information:
Title
Record any objective tumor responses which may occur
Time Frame
duration of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be diagnosed with previously treated breast, lung, or prostate cancer where docetaxel is indicated.
Prior treatment; at least one prior regimen required.
Able to perform the activities of daily living.
Off prior cancer therapy for at least 4 weeks.
If female neither pregnant nor nursing.
Willing to use contraceptives to prevent pregnancy.
No other serious illnesses.
No other active malignancy.
No serious infections.
No other current drug therapy for the cancer.
Blood counts and blood chemistries in or near normal range.
Prior radiation is permitted.
Exclusion Criteria:
Active brain metastases.
Facility Information:
Facility Name
Investigational Site 008
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19499186
Citation
Moulder S, Dhillon N, Ng C, Hong D, Wheler J, Naing A, Tse S, La Paglia A, Dorr R, Hersh E, Boytim M, Kurzrock R. A phase I trial of imexon, a pro-oxidant, in combination with docetaxel for the treatment of patients with advanced breast, non-small cell lung and prostate cancer. Invest New Drugs. 2010 Oct;28(5):634-40. doi: 10.1007/s10637-009-9273-1. Epub 2009 Jun 6.
Results Reference
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Safety Study of Imexon Plus Docetaxel in Lung, Breast or Prostate Cancer Patients
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