Safety Study of Imexon Plus Docetaxel in Lung, Breast or Prostate Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Non-small Cell Lung Cancer, Breast Cancer, Prostate Cancer

Intervention / Treatment
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* Drug: imexon
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Docetaxel plus imexon | Drug: imexon<br>* IV variable dosages, days 1-5 every 21 days for duration of study<br>* Other names: Amplimexon;Drug: docetaxel<br>* IV once every 21 days for duration of study<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the tolerability |  | duration of study | 
| determine the maximally tolerated dose (MTD) |  | duration of study | 
| determine the dose limiting toxicities (DLT) of increasing doses of imexon in combination with standard doses of docetaxel |  | duration of study | 
| correlate changes in plasma glutathione (GSH) levels with imexon dose levels |  | cycle 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Record any objective tumor responses which may occur |  | duration of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hormone refractory prostate cancer