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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327288
• Other study ID #: AMP-010
• Status: Completed
• Phase: Phase 1
• First received: May 17, 2006
• Last updated: June 22, 2015
• Start date: October 2005
• Est. completion date: July 2008

Study information

• Verified date: June 2015
• Source: AmpliMed Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• imexon
IV variable dosages, days 1-5 every 21 days for duration of study
• docetaxel
IV once every 21 days for duration of study

Locations

Country	Name	City	State
United States	Investigational Site 008	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AmpliMed Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 lu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the tolerability		duration of study	Yes
Primary	determine the maximally tolerated dose (MTD)		duration of study	Yes
Primary	determine the dose limiting toxicities (DLT) of increasing doses of imexon in combination with standard doses of docetaxel		duration of study	Yes
Primary	correlate changes in plasma glutathione (GSH) levels with imexon dose levels		cycle 1	No
Secondary	Record any objective tumor responses which may occur		duration of study	No