Clinical trial NCT00327327: Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma
Official title: A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Adenocarcinoma
Lead sponsor: AmpliMed Corporation
Sponsor class: INDUSTRY
First posted: 2006-05-18
Enrollment: 105
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: AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug imexon in combination with an approved drug, gemcitabine, for the treatment of patients with previously untreated pancreatic cancer. The treatment consists of dosing with both imexon and gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the highest doses of the two drugs that can be safely combined together.


Eligibility criteria: Inclusion Criteria:

* Inoperable cancer of the pancreas.
* Blood cell counts and blood chemistries in or near normal range.
* Able to perform the activities of daily living.
* A projected life expectancy of at least 2 months.
* 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 current other drug therapy for the cancer or steroid therapy.
* Prior radiation is permitted as is chemotherapy given during radiation or to prevent relapse after surgical removal of the disease.

Exclusion Criteria:

* Prior chemotherapy for metastatic disease.
* Brain metastases

Primary outcomes:
measure: Determine maximally tolerated dose (MTD)
timeFrame: until MTD reached
measure: determine dose limiting toxicities.
timeFrame: until MTD reached
Secondary outcomes:
measure: Changes in plasma thiol levels
timeFrame: until MTD reached
measure: pharmacokinetics
timeFrame: until MTD reached
measure: objective tumor responses.
timeFrame: until MTD reached
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Ocoee
country: United States
facility: US Oncology Orlando, Cancer Centers of FL
state: Florida
city: Indianapolis
country: United States
facility: US Oncology Indiana
state: Indiana
city: Ann Arbor
country: United States
facility: Univ of Michigan
state: Michigan
city: Albany
country: United States
facility: US Oncology Albany, New York Oncology
state: New York
city: Kettering
country: United States
facility: US Oncology Kettering
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Ctr.
state: Pennsylvania
city: Norfolk
country: United States
facility: US Oncology, Virginia Oncology Assoc
state: Virginia
city: Vancouver
country: United States
facility: US Oncology Northwest, Northwest Cancer Specialists
state: Washington
Study officials:
affiliation: University of Michigan
name: Mark Zalupski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fox Chase Cancer Center
name: Steven Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen SJ, Zalupski MM, Modiano MR, Conkling P, Patt YZ, Davis P, Dorr RT, Boytim ML, Hersh EM. A phase I study of imexon plus gemcitabine as first-line therapy for advanced pancreatic cancer. Cancer Chemother Pharmacol. 2010 Jul;66(2):287-94. doi: 10.1007/s00280-009-1162-y. Epub 2009 Oct 24.