Safety Study of Imexon Plus Docetaxel in Lung, Breast or Prostate Cancer Patients - Full Text View

Sponsored by:	AmpliMed Corporation
Information provided by:	AmpliMed Corporation
ClinicalTrials.gov Identifier:	NCT00327288

Purpose

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.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer Breast Cancer Prostate Cancer	Drug: imexon Drug: docetaxel	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Lung Cancer Prostate Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Further study details as provided by AmpliMed Corporation:

Primary Outcome Measures:

Determine the tolerability [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
determine the maximally tolerated dose (MTD) [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
determine the dose limiting toxicities (DLT) of increasing doses of imexon in combination with standard doses of docetaxel [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
correlate changes in plasma glutathione (GSH) levels with imexon dose levels [ Time Frame: cycle 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Record any objective tumor responses which may occur [ Time Frame: duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2005
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Docetaxel plus imexon	Drug: imexon IV variable dosages, days 1-5 every 21 days for duration of study Drug: docetaxel IV once every 21 days for duration of study

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327288

Locations

United States, Texas
Investigational Site 008
Houston, Texas, United States, 77030

Sponsors and Collaborators

AmpliMed Corporation

More Information

Responsible Party:	AmpliMed Corporation ( Evan Hersh, VP Medical Affairs )
Study ID Numbers:	AMP-010
Study First Received:	May 17, 2006
Last Updated:	August 12, 2008
ClinicalTrials.gov Identifier:	NCT00327288
Health Authority:	United States: Food and Drug Administration

Keywords provided by AmpliMed Corporation:

Hormone refractory prostate cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Prostatic Diseases
Skin Diseases
Genital Neoplasms, Male
Breast Neoplasms
Urogenital Neoplasms
Genital Diseases, Male
Carcinoma

Docetaxel
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Prostatic Neoplasms
Carcinoma, Non-Small-Cell Lung
Breast Diseases
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009