Clinical trial NCT00327288: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Breast Cancer
Prostate Cancer
Keywords: Hormone refractory prostate cancer
Lead sponsor: AmpliMed Corporation
Sponsor class: INDUSTRY
First posted: 2006-05-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Determine the tolerability
timeFrame: duration of study
measure: determine the maximally tolerated dose (MTD)
timeFrame: duration of study
measure: determine the dose limiting toxicities (DLT) of increasing doses of imexon in combination with standard doses of docetaxel
timeFrame: duration of study
measure: correlate changes in plasma glutathione (GSH) levels with imexon dose levels
timeFrame: cycle 1
Secondary outcomes:
measure: Record any objective tumor responses which may occur
timeFrame: duration of study
Other outcomes:
Locations:
city: Houston
country: United States
facility: Investigational Site 008
state: Texas
Study officials:
References:
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.