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

This study has been completed.
Sponsor:
Information provided by:
AmpliMed Corporation
ClinicalTrials.gov Identifier:
NCT00327288
First received: May 17, 2006
Last updated: September 14, 2010
Last verified: September 2010
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Experimental: A
Docetaxel plus imexon
Drug: imexon
IV variable dosages, days 1-5 every 21 days for duration of study
Other Name: Amplimexon
Drug: docetaxel
IV once every 21 days for duration of study
Other Name: Taxotere

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Evan Hersh, VP Medical Affairs, AmpliMed Corporation
ClinicalTrials.gov Identifier: NCT00327288     History of Changes
Other Study ID Numbers: AMP-010
Study First Received: May 17, 2006
Last Updated: September 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AmpliMed Corporation:
Hormone refractory prostate cancer

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014